Ms. Mona Rowe
Brookhaven National Laboratory
Bldg. 134
Upton, NY 11973-5000
Phone: 631-344-2345
Fax: 631-344-3368
E-mail: mrowe@bnl.gov
Number of Human Subjects projects reported: 50
| BNL-96-265 | "General Magnetic Resonance Imaging (MRI) and Spectroscopic (MRS) Studies of Human Subjects" |
| BNL-99-301 | "PET Studies of Alcoholism: Measurement of Brain Glucose Metabolism and Dopamine Activity in Alcoholics During Early and Late Detoxification" |
| BNL-99-302 | "PET Studies of Alcoholism: Measurement of Brain Metabolism and Brain Dopamine Concentration with 18FDG and 11C-Raclopride" |
| BNL-99-317 | "PET Studies of Alcoholism: Measurement of the Effect of Alcohol Intoxication on Brain Glucose Metabolism" |
| BNL-99-348 | "Monitoring Methamphetamine Abuse Treatment with 1H MRS" |
| BNL-99-349 | "Brain Activation Studies in Patients with Early HIV Dementia" |
| BNL-00-324 | "PET Studies of Catechol-O-Methyltransferase (COMT) with [18F]Ro-41-0960" |
| BNL-00-325 | "PET Studies of Monoamine Oxidase (MAO)" |
| BNL-00-326 | "Brain Dopamine and Reward and Motivation in Controls and Substance Abusers" |
| BNL-00-328 | "Perception of Pleasure and Control of Behavior in Drug Addiction: An fMRI Study" |
| BNL-00-344 | "Blood Brain Barrier Permeability and the Menstrual Cycle" |
| BNL-01-345 | "Brain Imaging Studies of Obesity" |
| BNL-01-346 | "PET Studies of Monoamine Oxidase (MAO) and Brain Glucose Metabolism in Alzheimer's Disease" |
| BNL-01-350 | "PET Imaging Studies of Brain Dopamine: Changes in Subjects Infected with Human Immunodeficiency Virus (HIV)" |
| BNL-01-352 | "PET Studies of Cocaine Abuse: Effects of Expectation" |
| BNL-01-353 | "PET Studies in Attention Deficit Disorder: Role of Dopamine" |
| BNL-01-355 | "Blood Brain Barrier Permeability in MS Lesion Development" |
| BNL-01-357 | "Magnetization Transfer Imaging and MR Spectroscopy in Elderly Schizophrenics" |
| BNL-01-359 | "Cerebrovascular Changes in HIV and Psychostimulant Drug Abuse" |
| BNL-01-360 | "Attentional Modulation in Early Sensory Processing" |
| BNL-01-362 | "Investigation of the "Early Response" in Functional MRI" |
| BNL-01-363 | "Precise In Vivo Measurement of Brain Metabolites" |
| BNL-02-364 | "Brain Dopamine, Reward and Motivation in Obese Subjects With and Without a Binge Eating Disorder" |
| BNL-02-365 | "Imaging of Neuroendocrine Tumors Using PET (COMT)" |
| BNL-02-366 | "Water Spaces in Leg Muscle Before and After Exercise" |
| BNL-02-367 | "Heavy Ion Induced Chromosome Damage and Biomedical Countermeasures" |
| BNL-02-369 | "Clinical Correlates of Longitudinal Changes in Alzheimer's Disease: A Glucose Challenge Study" |
| BNL-02-370 | "Imaging of Brain Metabolic Responses to Food Presentation" |
| BNL-02-371 | "Botulinum Toxoid" |
| BNL-02-372 | "Characterization of Dopamine Transporter Blockade by GW353162 in the Human Brain" |
| BNL-02-373 | "Methamphetamine Effects in Brain Dopamine Activity" |
| BNL-02-374 | "Clinical Correlates of Longitudinal PET Changes in Normal Aging, Mild Cognitive Impairment and Alzheimer's Disease " |
| BNL-02-377 | "Proton Magnetic Resonance Spectroscopy (1H MRS) in Schizophrenia (Project 5 of Conte Center Grant through Mt. Sinai Medical Center)" |
| BNL-03-378 | "K Determination in Brain" |
| BNL-03-381 | "Brain Metabolic Response to Images of Violent Behavior" |
| BNL-03-382 | "Effects of Atomoxetine Versus Methylphenidate on Dopamine in the Human Brain" |
| BNL-03-383 | "Effects of Marijuana Abuse on Brain Activation, Neurometabolites and Cognition" |
| BNL-03-384 | "Sodium MRI of the Brain" |
| BNL-03-385 | "Monoamine Oxidase (MAO) Genetics and Brain Function" |
| BNL-03-386 | "PET Imaging of Nicotinic Receptors" |
| BNL-03-387 | "Acoustic Interference on Attention in HIV Patients" |
| BNL-03-388 | "Measurement of Dopamine Systems in Subjects At-Risk for Alcoholism" |
| BNL-03-389 | "Effects of Shielding on Space Radiation Biological Effectiveness" |
| BNL-03-390 | "Brain Dopamine Function in Adults with ADHD" |
| BNL-03-391 | "Brain Activation and Neurometabolites in Attention Deficit Hyperactivity Disorder" |
| BNL-03-392 | "Pharmacological MRI to Evaluate the Pharmacokinetics of Methylphenidate Infusion" |
| BNL-03-393 | "Non-Invasive Blood Radioactivity Monitor" |
| BNL-04-394 | "Brain Metabolic Response to Satiety Control: Effects of Implantable Gastric Stimulation (IGS)" |
| BNL-04-398 | "Medical Surveillance of Current BNL Employees Identified as Beryllium Exposed" |
| BNL-04-399 | "Imaging of Brain Metabolic Response to Mathematical Task" |
"General Magnetic Resonance Imaging (MRI) and Spectroscopic (MRS) Studies of Human Subjects"
Principal Investigator: Dr. William Rooney, Brookhaven National Laboratory
Project started in: 1996
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 04/15/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 12
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
The goal of this research is to evaluate tissue magnetic resonance signal relaxivities at the 4 Tesla (4T) field strength and to conduct research aimed at increasing our understanding of the mechanisms and evolution of normal tissue function and human disease states. This work will not be used for routine diagnosis. About 300 studies, all of normal adult volunteers, are ultimately expected to be made in a year. No radiopharmaceuticals (drugs) or surgical procedures will be used in this study. Each participant will be asked to complete an entry questionnaire prior to completing a consent form and being allowed into the magnet. The purpose of the entry questionnaire is to screen out individuals who may have problems in the magnet caused by metal implants, claustrophobia, etc. During the study, the subjects will be monitored visually and communicated with via a two-way intercom from the control room where the operator is located. Because of the strong magnetic field, individuals with surgically implanted metallic devices such as clips, artificial joints, certain heart valves and pacemakers will be excluded from this study, as well as subjects with claustrophobia. The possible risks due to the magnet itself are primarily related to the slight possibility of a sensation of dizziness or nausea as the subject moves in and out of the magnet or moves their head in the magnet. The magnet is thought to be able to exert a force on the fluid within the semicircular canals near the ears, thus giving a sensation of disequilibrium. The sensations go away if the head is not in motion or if the individual is not moving in and out of the magnet. Subjects are exposed to noise from the machine, for which earplugs are provided. All records are confidential and may not be disclosed without the subject's written consent with the exception that the FDA and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
"PET Studies of Alcoholism: Measurement of Brain Glucose Metabolism and Dopamine Activity in Alcoholics During Early and Late Detoxification"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 1999
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 04/15/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 9
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
Dopamine is a chemical compound in the brain which is important in movement and in feelings of reward and well-being. Recent positron emission tomography (PET) imaging studies have shown that dopamine activity and brain metabolism are abnormally low in alcoholics. An important question is whether these systems recover when subjects withdraw from alcohol. To do this, a PET camera will be used to visualize dopamine activity (using [11C]raclopride and [11C]d-threo-methylphenidate or [11C]cocaine as tracers) and brain sugar metabolism (using F-18-fluorodeoxyglucose (18FDG) as a tracer) in alcoholics and a comparison group of at-risk and control subjects. Imaging will be done on two different days, four to six weeks apart to assess recovery. The radiotracers used are labeled with the short lived isotopes, carbon-11 (half life: 20.4 minutes) and fluorine-18 (half life: 110 minutes). Forty alcoholic subjects, sixteen non-alcoholic subjects and forty subjects at risk for alcoholism will be enrolled in the study in order to complete 16 in each group. The information from this study will add to our understanding of the relationship between changes in brain dopamine activity and brain metabolism and the degree to which deficits recover when alcoholics stop drinking. The use of a control population is necessary as a comparison group. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. All records are confidential and may not be disclosed without the subject's written permission with the exception that the FDA and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
"PET Studies of Alcoholism: Measurement of Brain Metabolism and Brain Dopamine Concentration with 18FDG and 11C-Raclopride"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 1999
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 05/20/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 11
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
Dopamine is a chemical compound in the brain which is important in movement and in feelings of reward and well-being. The goal of this study is to find out whether alcoholics and cocaine abusers have different brain dopamine function than non-alcoholic and non-cocaine addicted subjects. This will be done with a brain imaging method called positron emission tomography (PET). A PET camera will visualize how much dopamine the brain releases and also how certain brain regions become activated in response to the injection of methylphenidate, a stimulant drug known to release dopamine. Dopamine release will be measured using a radiotracer called [11C]raclopride and brain activation will be measured using a radiotracer called F-18 fluorodeoxyglucose. Both C-11 and F-18 are radioisotopes of short half life. Subjects will be tested on two different days with both of these radiotracers. On one day, they will receive a saline solution and on the other methylphenidate. They will not know on which day they will receive the saline or the methylphenidate. Fifteen alcoholic subjects, ten normal controls and five subjects at risk for alcoholism will be studied. The ability of the human brain to release dopamine in response to a drug challenge as well as its ability to activate certain brain areas is important in understanding human behavior and the mechanisms involved in alcohol and cocaine addiction. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. All records are confidential and may not be disclosed without the subject's written permission with the exception that the FDA and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
"PET Studies of Alcoholism: Measurement of the Effect of Alcohol Intoxication on Brain Glucose Metabolism"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 1999
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 01/21/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
This study will measure the acute effects of alcohol on brain glucose metabolism in normal subjects. Twenty normal controls (male and female) will be recruited. Each subject will undergo two to three positron emission tomography (PET) scans (a type of imaging device) with 4.5 millicuries (mCi) of 18-fluorodeoxyglucose (18FDG), a radioactive analog of glucose (sugar), to estimate glucose metabolism in various parts of the brain. One of the scans will be done with a placebo (diet soda), and the other two will be done after administration of alcohol (0.75 grams per kilogram body weight (g/kg) and either 0.25 or 0.5 g/kg). The study will take two to three days. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. Alcohol impairs motor coordination and subjects should not drive or perform any activity that requires motor skills on the day of the study. It can also cause nausea and/or vomiting. Also, the use of alcohol with other drugs may be dangerous. All records are confidential and may not be disclosed without the subject's written permission with the exception that the FDA and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
"Monitoring Methamphetamine Abuse Treatment with 1H MRS"
Principal Investigator: Dr. Linda Chang, Brookhaven National Laboratory
Project started in: 1999
This project ended in fiscal year 2004.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 04/15/03
Explanation of IRB approval:
Protocol was inactivated 04/13/04.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 17
Reporting period for number of human subjects:
Other: 04/15/03 to 04/13/04
Explanation:
Protocol was inactivated 04/13/04.
Type(s) of Human Subjects Involvement:
The purpose of this study is to find out whether people who were dependent on methamphetamine have abnormal brain chemistry or abnormal thinking and memory, and to determine whether behavioral treatment for methamphetamine-dependence is associated with improvement of brain chemicals and thinking processes. Also, the study will determine whether magnetic resonance spectroscopy (MRS) can be used as a tool to predict the length of time to relapse. Subjects will be asked to undergo a brain scan known as magnetic resonance imaging/magnetic resonance spectroscopy (MRI/MRS) which uses a strong magnet and radio waves to generate signals that indicate the amounts of a variety of important chemicals in the body. Subjects will also be given a series of neuropsychological tests that examine the subject's psychomotor speed, fine and gross motor functioning, and various cognitive functions. The subject population for this study will include 75 subjects who have been dependent on methamphetamine and 30 healthy drug-free control subjects. We expect to study approximately equal numbers of male and female subjects over the next two years for a combined total of 105 subjects. All 75 subjects who have been dependent on methamphetamine will repeat the study at four months and nine months after initial evaluation. The effects of inserting needles to draw blood are usually some pain, bleeding and/or a bruise or swelling where the needle was inserted, and on rare occasions, infection. Occasionally the area around the vein may swell. Any area where the skin anesthetic will be applied may become red and/or irritated. The neuropsychological testing and evaluation may make subjects feel uncomfortable.
All records are confidential and may not be disclosed without the subject's written permission, except that the FDA and/or funding agencies may inspect the records.
"Brain Activation Studies in Patients with Early HIV Dementia"
Principal Investigator: Dr. Thomas Ernst, Brookhaven National Laboratory
Project started in: 1999
This project ended in fiscal year 2004.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 10/21/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Other: 10/21/03 to 04/13/04
Explanation:
Protocol was inactivated 04/13/04.
Type(s) of Human Subjects Involvement:
The purpose of this research is to determine the effects of the human immunodeficiency virus (HIV) on the mental processing (functioning of the brain) in AIDS patients, using several magnetic resonance imaging (MRI) techniques. Brain function will be examined using a technique called functional MRI (fMRI). The study will observe the response of the brain to different functions (such as seeing, remembering, or moving body parts). In addition, a perfusion magnetic resonance imaging (pMRI) scan will be done to observe blood flow in the brain. This research study will enroll subjects who are HIV-positive and subjects who are HIV-negative and are healthy. Subjects will also be given a series of neuropsychological tests that examine the subject's psychomotor speed, fine and gross motor functioning, and various cognitive functions. The subject population for this study will include 20 early HIV-CMC (HIV-cognitive motor complex; ADC stages 0.5 and 1) subjects, 20 HIV subjects without cognitive deficits (ADC stage 0), 20 subjects with HIV-CMC (ADC stages 0.5 and 1) who have never been treated with antiretroviral drugs, and 20 healthy control subjects. We expect to study 80 subjects over the next two years. Due to the gender distribution of the disease (HIV) approximately 75 percent of the total subjects studied will be male and approximately 25 percent will be female. Only 40 subjects (antiretroviral drug naive subjects) will repeat the study three months after initial evaluation. The major risk of the spinal tap is pain on the back where the spinal tap was done. Some individuals develop a headache that can last for days; prolonged headache develops in only 1 in 50 to 1 in 200 subjects. This headache is usually relieved with Tylenol (acetaminophen), drinking a lot of fluids and lying flat. A persistent headache may result from continued spinal fluid leakage. The effects of inserting needles to draw blood are usually some pain, bleeding and/or a bruise or swelling where the needle was inserted and on rare occasions, infection. Occasionally the area around the vein may swell. Any area where the skin anesthetic will be applied may become red and/or irritated. The neuropsychological testing and evaluation may make subjects feel uncomfortable. The risks of a gadolinium injection include discomfort and bruising at the site of puncture and, less commonly, the formation of a small blood clot or swelling of the vein and nearby tissue and bleeding from the puncture site. A small number of people have had bad reactions to the gadolinium contrast agent solution. Some of the bad reactions include headache, dizziness, metallic taste in mouth, nausea, and rash or hives. Death has been reported due to severe allergic reactions, but this has been an extremely rare occurrence with an estimated risk of 1 in 500,000.
All records are confidential and may not be disclosed without the subject's written permission, except that the FDA and/or funding agencies may inspect the records.
"PET Studies of Catechol-O-Methyltransferase (COMT) with [18F]Ro-41-0960"
Principal Investigator: Dr. Yu-Shin Ding, Brookhaven National Laboratory
Project started in: 2000
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 02/21/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
COMT (catechol-O-methyltransferase) is a natural enzyme in the body that is sometimes found in greater amounts in certain breast tumors. The purpose of this study is to determine whether the larger amounts of COMT can be seen in breast cancer with positron emission tomography (PET), a medical imaging method similar to a camera, and whether this information can be of value in breast cancer diagnosis and treatment. The procedure will involve PET scanning with a tracer called [18F]Ro41-0960, which links itself with the COMT already in the tumor. Subjects with breast cancer who are scheduled to undergo surgery will have a PET scan within two weeks preceding the surgery. The results of the PET scan will be compared with the results obtained by examination of the surgical sample, which is removed during the surgery. If PET and the experimental tracer [18F]Ro41-0960 provide diagnostic information, it could reduce the need for unnecessary breast biopsies and make current diagnostic procedures better. This study may also provide knowledge which may suggest new treatments for breast cancer. Twenty breast cancer patients will be studied up to two times each.
A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as that delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
All records are confidential and may not be disclosed without the subject's written permission with the exception that the FDA and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
"PET Studies of Monoamine Oxidase (MAO)"
Principal Investigator: Dr. Joanna S. Fowler, Brookhaven National Laboratory
Project started in: 2000
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 09/17/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
We are developing methods to image the enzyme monoamine oxidase (MAO) in the human body. This is an important baseline study which will allow future studies to assess the potential effect of drugs, foods, or other exposures that inhibit MAO. Drug studies, however, are not a part of this effort. MAO breaks down neurotransmitter amines and vasoactive chemical compounds present in certain fermented foods, drugs, and beverages. If MAO is inhibited, the individual is at risk for dangerous elevations in blood pressure. Therefore, a knowledge of the effect of drugs and other substances on MAO is important. Positron emission tomography (PET) imaging will allow this assessment to be made directly in the human body. MAO exists in two subtypes, MAO A and MAO B which differ in their selectivity for breaking down different chemical compounds.
We are studying 36 subjects in two years. We will measure MAO A and/or MAO B in each subject. MAO A will be measured using [11C]clorgyline and [11C]clorgyline-D2 (deuterium substituted [11C]clorgyline) and MAO B will be measured using [11C]L-deprenyl and [11C]L-deprenyl-D2 (deuterium substituted [11C]L-deprenyl). Volunteers may participate in either or both of these studies. If they participate in one of the studies they will receive two PET scans and if they participate in both of the studies, they will receive four PET scans.
A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as that delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
All records are confidential and may not be disclosed without the subject's written permission with the exception that the FDA and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
"Brain Dopamine and Reward and Motivation in Controls and Substance Abusers"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 01/21/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 15
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
For Study #1, we will use positron emission tomography (PET) to assess the involvement of dopamine (DA) in motivation and reinforcing behavior in healthy control subjects using food stimulation (n=10), mathematical stimulation (n=20), and video stimulation (n=10) and to compare these responses to neutral stimulation. For Study #2, we will compare responses to reinforcing (behavioral) stimuli and neutral stimuli in cocaine abusers (n=20) and healthy control subjects (n=20). We will compare the responses to drug and non-drug related behavioral reinforcers (stimulation) and compare these responses to neutral stimulation.
For this study, we predict that (1) DA in human subjects will be involved with reward and motivational circuits and (2) cocaine abusers will have decreased activation of reward circuits by naturally rewarding stimuli when compared with controls, but they will have very robust responses to drug related stimuli.
In addition to the above, we will contact obese subjects (n=10) who participated in a comparable study to see if their obesity status is similar to what it was a few years ago, and if it is, we will ask these subjects to return to BNL to complete the Dutch Eating Behavior Questionnaire. We want to investigate whether obese subjects have different eating behaviors from normal body weight subjects and to correlate their eating behaviors with the PET results obtained from another protocol. The reason for this is that this study has shown that brain DA is involved with the restraint and emotionality components regulating eating behavior in humans and that these two dimensions reflect different neurobiological processes in normal body weight subjects (control subjects). The total number of subjects approved for this study is 90.
All records are confidential and may not be disclosed without the subject's written permission with the exception that funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
"Perception of Pleasure and Control of Behavior in Drug Addiction: An fMRI Study"
Principal Investigator: Dr. Rita Goldstein, Brookhaven National Laboratory
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 03/18/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 12
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The goal of this application is to evaluate human brain function implicated in the perception of pleasure and control of behavior by simultaneous functional magnetic resonance imaging (fMRI) recordings and behavioral assessment. Specifically, this project will examine whether chronic use of cocaine and/or alcohol changes the pattern of this brain activity in such a way as to increase the uncontrollable use of these drugs. The results of this work will provide information on the brain circuits underlying drug-related behaviors, emotions and cognitions, which may then open a possibility of timely intervention and prevention of drug addiction. The human brain mapping will be obtained using a 4 Tesla (4T) magnetic resonance imaging scanner with presentations of visual and/or auditory stimuli to subjects in the scanner. No radiopharmacueticals, chemicals (drugs) or surgical procedures will be used in this study. The total duration of the fMRI study will be two hours or less. Subjects will include 20 normal controls, 20 cocaine abusers, and 20 alcoholics.
The study is considered to involve minimal risk. No serious ill effects have been reported to date from any site operating with 4T magnetic field strength. Because of the strong magnetic field, however, subjects will be screened for the presence of any surgically implanted metallic devices such a clips, artificial joints, heart valves, and pacemakers. Since the study involves entering a confining space (the magnet), subjects may not be able to participate if they have a history of claustrophobia, or if they experience anxiousness when entering the magnet. The risks due to the magnet are primarily related to the slight possibility of a sensation of dizziness or nausea as subjects move into and out of the magnet, or move their head within the magnet. All records are confidential and may not be disclosed without the subject's written permission with the exception that the FDA and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
"Blood Brain Barrier Permeability and the Menstrual Cycle"
Principal Investigator: Dr. William Rooney, Brookhaven National Laboratory
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 08/17/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 05/20/03 to 08/17/04
Explanation:
Protocol was inactivated for a few months.
Type(s) of Human Subjects Involvement:
One of the unique properties of brain blood vessels is the so-called "blood-brain barrier," which is important in brain volume regulation and in protecting brain cells from potentially toxic substances in the blood. Multiple sclerosis (MS) is a disease of unknown origin that produces lesions in the brain and spinal cord disease, and it is believed that an initiating event in new lesion formation is the transient disruption of the blood-brain barrier. MS strikes women twice as often as men. Several studies have raised the possibility that menstrual cycle hormones influence MS disease activity and could account for why women are at increased risk for the disease. The primary question that we address in this study is the extent to which the blood-brain barrier permeability changes with hormone levels that vary during the menstrual cycle. A secondary question is whether these changes are greater in women that have MS. Ten women between the ages of 18 and 40 years will be enrolled; five women with MS and five healthy women as controls. Dr. Patricia Coyle will recruit the MS candidates from the Multiple Sclerosis Comprehensive Care Center at the State University of New York at Stony Brook. All MS candidates will undergo an initial screening visit at Stony Brook. All enrolled participants will undergo a contrast enhanced magnetic resonance imaging (MRI) exam every week for four weeks at Brookhaven National Laboratory. Eight to ten teaspoons of blood will be withdrawn at each MRI examination to measure hormone and contrast agent levels. The contrast agent is an FDA approved compound that has an excellent safety profile. The high-field MRI scanner at Brookhaven National Laboratory will be used because it has a better ability to detect low levels of contrast agent than standard clinical scanners.
The study is considered to involve minimal risk. No serious ill effects have been reported to date from any site operating with 4 Tesla (4T) magnetic field strength. Because of the strong magnetic field, however, subjects will be screened for the presence of any surgically implanted metallic devices such a clips, artificial joints, heart valves, and pacemakers. Since the study involves entering a confining space (the magnet), subjects may not be able to participate if they have a history of claustrophobia, or if they experience anxiousness when entering the magnet. The risks due to the magnet are primarily related to the slight possibility of a sensation of dizziness or nausea as subjects move into and out of the magnet, or move their head within the magnet. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. A small number of people have had bad reactions to the gadolinium contrast agent solution. Some of the bad reactions include headache, dizziness, metallic taste in mouth, nausea, and rash or hives. Death has been reported due to severe allergic reactions, but this has been an extremely rare occurrence with an estimated risk of 1 in 500,000.
All records are confidential and may not be disclosed without the subject's written permission with the exception that the FDA and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
"Brain Imaging Studies of Obesity"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2001
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 10/15/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The prevalence of obesity is increasing worldwide. The mechanisms leading to the loss of control of food intake are not understood. Dopamine (DA) is one of the neurotransmitters that involve feeding behavior and its pharmacological manipulation has marked effects in food intake. Abnormal dopaminergic activity has been demonstrated in genetically inbred mice for obesity and has been postulated to underlie disorders entailing compulsive behaviors such as overeating. Our prior study showed that striatal DA D2 receptor availability was significantly lower in obese than in control subjects. It has been postulated that subjects who have low dopamine activity are more prone to self-administer food or reinforcing drugs as a way of compensating for the decreased dopaminergic activity. Animal studies indicate a decrease in body weight by dietary restriction increases DA D2 receptor concentration. Bariatric operations include procedures that decrease the volume capacitance of the stomach or establish a partial selective malabsorption are used to induce weight loss. These surgical procedures have been proven to be effective at inducing and maintaining a significant weight loss. The purpose of this study is to investigate if changes in the brain dopamine system of obese individuals revert to normal with surgically assisted weight loss. The study will evaluate 30 obese subjects (body mass index > 40 kg/m2) who are to undergo bariatric surgery and 30 control subjects in the age range 20 to 55 years of age. Obese subjects will be tested prior to and 6 to 12 months after surgery. Each evaluation will entail studies with two tracers, to measure postsynaptic DA sites ([11C]raclopride for dopamine D2 receptors) and to measure regional brain function (18F-fluorodeoxyglucose, for regional glucose metabolism) using positron emission tomography (PET) scans. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. All records are confidential and may not be disclosed without the subject's written permission, except that the FDA and/or funding agencies may inspect the records.
"PET Studies of Monoamine Oxidase (MAO) and Brain Glucose Metabolism in Alzheimer's Disease"
Principal Investigator: Dr. Joanna S. Fowler, Brookhaven National Laboratory
Project started in: 2001
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 09/17/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
In this study we propose to determine whether monoamine oxidase B (MAO B) imaging with positron emission tomography (PET) and [11C]L-deprenyl-D2 can be used to detect plaque formation in Alzheimer's disease at very early stages and whether it tracks the progression of symptoms. Ultimately the goal is to have a marker which is predictive and which can be used to determine whether new therapies are effective against disease progression. We will recruit subjects with Alzheimer's disease who are part of a longitudinal study (a study where the same subject is followed over time) at Mt. Sinai School of Medicine (MSSM) and a group of age-matched healthy subjects (including the spouses of the patients). There will be 16 subjects in each group. Each subject will receive a PET scan with [11C]L-deprenyl-D2 (to measure brain MAO B). If subjects agree, they may also have an 18FDG scan to measure brain function which will be of value in assessing whether regions with high MAO B also have diminished brain function. The scans may be repeated 12 to 24 months later (based on the assessment of the subject by the Mt. Sinai physician) to assess whether changes in the PET scans track the progression of symptoms. We have successfully used [11C]L-deprenyl-D2 to map MAO B in the normal human brain. A magnetic resonance imaging/magnetic resonance spectroscopy (MRI/MRS) scan will be run on the same day or near in time to the PET scan to detect structural changes and to assess gliosis (a proliferation of glial cells (the major type of brain cell)) through measurement of myoinositol (a chemical compound) which is elevated in gliosis. The MRI/MRS scan will serve as an additional descriptive measure of the increase in glial cells in the brain. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. All records are confidential and may not be disclosed without the subject's written permission, except that the FDA and/or funding agencies may inspect the records.
"PET Imaging Studies of Brain Dopamine: Changes in Subjects Infected with Human Immunodeficiency Virus (HIV)"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2001
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 12/17/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 18
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
Clinical and laboratory studies indicate human immunodeficiency virus (HIV) infection frequently results in brain dopaminergic dysfunction and dementia. This dementia syndrome is called HIV cognitive motor complex (CMC). The purpose of this study is to investigate changes in the brain dopamine system of subjects infected with HIV and the efficacy of highly active antiretroviral treatment. The study will compare 80 HIV subjects with or without a history of psychostimulant drug use, 20 to 65 years of age who have not yet begun highly active antiretroviral medication, with 20 age matched healthy control subjects. Each evaluation will entail positron emission tomography (PET) studies with two tracers to measure: postsynaptic dopamine (DA) sites ([11C]raclopride for dopamine D2 receptors) and presynaptic DA sites ([11C]cocaine for dopamine transporter). HIV subjects will be asked to repeat testing 6 to 12 months after treatment using the same two tracers. We predict that subjects with HIV dementia have a decrease in DA transporters, which leads to Parkinsonian signs and HIV-CMC. We postulate that these abnormalities are partially compensated with normal or up regulated DA receptors. We predict that effective highly active antiretroviral treatment will improve dopamine function. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. Any area where the skin anesthetic will be applied may become red and/or irritated. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. All records are confidential and may not be disclosed without the subject's written permission, except that the FDA and/or funding agencies may inspect the records.
"PET Studies of Cocaine Abuse: Effects of Expectation"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2001
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 12/17/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 11
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this study is to compare the activation of the brain in response to intravenous methylphenidate (brand name Ritalin), a drug that, like cocaine, also blocks removal of dopamine. Brain activation will be compared to when cocaine abusers are expecting to receive the drug versus to when they are not, and to assess if expectation can activate a similar circuit to that activated by the drug. For this purpose, we will measure regional brain glucose metabolism using positron emission tomography (PET) and 18-fluorodeoxyglucose (18FDG) as a radiotracer, which serves as an index of brain function in current cocaine abusers under four different conditions: 1) subjects are told they will receive placebo and are given placebo; 2) subjects are told they will receive methylphenidate and are given placebo; 3) subjects are told they will receive methylphenidate and are given methylphenidate; and 4) subjects are told they will receive placebo and are given methylphenidate. We will study 24 active cocaine abusers and 24 normal control subjects over a three-year period. Each subject gets four 18FDG injections and each injection is given on a different day. A magnetic resonance imaging (MRI) scan is also run to assess structural abnormalities, such as atrophy.
Methylphenidate is a mild central nervous system stimulant used to treat attention deficit disorder and narcolepsy. It increases heart rate and blood pressure and can cause a behavioral "high." It can also elicit negative feelings of anxiety. In the event that either cardiovascular or behavioral complications occur, they can be effectively treated with an intramuscular injection of a neuroleptic. There is also some evidence that methylphenidate may lower the seizure threshold in some individuals who have a prior history of seizure disorders. Therefore, methylphenidate will not be given to patients with cardiac disease or patients with seizure disorders. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. All records are confidential and may not be disclosed without the subject's written permission, except that the FDA and/or funding agencies may inspect the records.
"PET Studies in Attention Deficit Disorder: Role of Dopamine"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2001
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 12/17/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 15
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this research is to assess if there are changes in the brain of subjects with attention deficit hyperactivity disorder (ADHD). More specifically, we want to assess if there are abnormalities in brain dopamine (DA), which is a chemical that regulates attention and motor activity in the brain. Dopamine is also the chemical that is affected by drugs used in the treatment of ADHD such as Ritalin and Adderall. We will use positron emission tomography (PET) to measure dopamine brain activity in adult subjects with ADHD. We will use [11C]cocaine to measure dopamine transporters (DAT), and we will use [11C]raclopride with and without methylphenidate pretreatment to measure changes in extracellular dopamine. ADHD is a disorder characterized by hyperactivity and attention problems that affects five to ten percent of the general population. Despite the large numbers of people affected by ADHD, very little is known about what causes it. In this study brain DA activity will be measured using an imaging camera called PET to image the molecules involved in the communication of the dopamine signals in the brain (dopamine transporters, DAT, dopamine receptors, and dopamine itself). We will complete studies in no more than 50 subjecs: 25 with ADHD and 25 normal controls. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
Methylphenidate is a mild central nervous system stimulant used to treat attention deficit disorder and narcolepsy. It increases heart rate and blood pressure and can cause a behavioral "high." It can also elicit negative feelings of anxiety. In the event that either cardiovascular or behavioral complications occur, they can be effectively treated with an intramuscular injection of a neuroleptic. There is also some evidence that methylphenidate may lower the seizure threshold in some individuals who have a prior history of seizure disorders. Therefore, methylphenidate will not be given to patients with cardiac disease or patients with seizure disorders. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. All records are confidential and may not be disclosed without the subject's written permission, except that the FDA and/or funding agencies may inspect the records.
"Blood Brain Barrier Permeability in MS Lesion Development"
Principal Investigator: Dr. William Rooney, Brookhaven National Laboratory
Project started in: 2001
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 02/21/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this study is to determine if brain blood vessels let contrast agent or water pass through more easily in people with multiple sclerosis (MS) than in people who do not have the disease. This information may help investigators better diagnose and possibly identify brain regions where lesions may soon appear. Twenty five MS subjects and twenty five control subjects will undergo scanning with an research-dedicated magnetic resonance imaging (MRI) instrument. MS subjects and controls will be studied at multiple times. Each subject will receive an injection of a FDA approved gadolinium-based contrast agent which will assist the investigators in measuring brain blood vessel properties. The MRI machine creates a strong magnetic field. If subjects have certain metal objects in the body, for example, metal fragments in the eye, non-removable hearing aids, nerve stimulators, or pacemakers, they would not be allowed to enter the magnet area and cannot participate in this study. Subjects may be bothered by feelings of claustrophobia while in the scanner. Because the magnetic resonance imaging/magnetic resonance spectroscopy (MRI/MRS) scanner makes loud "knocking" noises, they are asked to wear earplugs. While the MRI/MRS makes the "knocking" noise, subjects might feel a tingling sensation in their arms or legs, but it is unlikely that this will occur. Subjects may become dizzy or experience a metallic taste in the mouth if they move the head quickly in the magnet. The radio waves produced by the scanner could cause a warm sensation, but this is unlikely. Although the long-term risk of exposure to the MRI/MRS machine is not known, there is no known long-term risk based on the information collected over the past 20 years. The effects of inserting needles to draw blood are usually some pain, bleeding and/or a bruise or swelling where the needle was inserted and on rare occasions, infection. Occasionally the area around the vein may swell. The risks of a gadolinium injection include discomfort and bruising at the site of puncture and, less commonly, the formation of a small blood clot or swelling of the vein and nearby tissue and bleeding from the puncture site. A small number of people have had bad reactions to the gadolinium contrast agent solution. Some of the bad reactions include headache, dizziness, metallic taste in mouth, nausea, and rash or hives. Death has been reported due to severe allergic reactions, but this has been an extremely rare occurrence with an estimated risk of 1 in 500,000. All records are confidential and may not be disclosed without the subject's written permission, except that the FDA and/or funding agencies may inspect the records.
"Magnetization Transfer Imaging and MR Spectroscopy in Elderly Schizophrenics"
Principal Investigator: Dr. Linda Chang, Brookhaven National Laboratory
Project started in: 2001
This project ended in fiscal year 2004.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 06/17/03
Explanation of IRB approval:
Protocol was inactivated 04/13/04.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Other: 06/17/03 to 04/13/04
Explanation:
Protocol was inactivated 04/13/04.
Type(s) of Human Subjects Involvement:
This is a study to understand the dementia that sometimes affects schizophrenics as they age past 60 years. We intend to compare the brains of three groups: elderly people with schizophrenia and dementia, elderly people with schizophrenia without dementia, and elderly people with neither schizophrenia nor dementia. We will do the examinations with a magnetic resonance scanner. The information we will get from the magnetic resonance scanner will tell us about the chemical composition of the brains of the three groups. We hope by exploring the differences between the groups we will learn why some people with schizophrenia experience a decline in functioning and others do not. Subjects and controls will undergo written psychological tests, receive a physical exam, an electrocardiogram (EKG), and basic blood and urine tests to make sure they are not acutely ill or using drugs. After these tests they will be scanned in a magnetic resonance scanner for about two hours. We will evaluate patients with several magnetic resonance imaging (MRI) techniques: structural, magnetization transfer (a way of evaluating myelin), and spectroscopy (a way of measuring chemicals in the brain). The MRI machine creates a strong magnetic field. If subjects have certain metal objects in your body, for example, metal fragments in the eye, non-removable hearing aids, nerve stimulators, or pacemakers, they would not be allowed to enter the magnet area and cannot participate in this study. Subjects may be bothered by feelings of claustrophobia (feeling enclosed) while in the scanner. Because the MRI/MRS makes loud knocking noises, they are asked to wear earplugs. While the MRI/MRS makes the knocking noise, subjects might feel a tingling sensation in their arms or legs, but it is unlikely that this will occur. Subjects may become dizzy or experience a metallic taste in the mouth if they move their head quickly in the magnet. The radio waves produced by the scanner could cause a warm sensation, but this is unlikely. Although the long-term risk of exposure to the MRI/MRS machine is not known, there is no known long-term risk based on the information collected over the past 20 years.The effects of inserting needles to draw blood are usually some pain, bleeding and/or a bruise or swelling where the needle was inserted and on rare occasions, infection. Occasionally the area around the vein may swell. All records are confidential and may not be disclosed without the subject's written permission, except that the FDA and/or funding agencies may inspect the records.
"Cerebrovascular Changes in HIV and Psychostimulant Drug Abuse"
Principal Investigator: Dr. Linda Chang, Brookhaven National Laboratory
Project started in: 2001
This project ended in fiscal year 2004.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 05/20/03
Explanation of IRB approval:
Protocol was inactivated 04/13/04.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 7
Reporting period for number of human subjects:
Other: 05/20/03 to 04/13/04
Explanation:
Protocol was inactivated 04/13/04.
Type(s) of Human Subjects Involvement:
The purpose of this study is to understand whether damage to the blood brain barrier (BBB) or changes in blood flow in the brain occur in HIV patients with or without a history of stimulant drug dependence. Subjects will be injected with a contrast agent then scanned with an ultra-fast magnetic resonance scanning technique to measure how quickly the contrast agent passes through the brain. The investigators will also measure how much of the contrast agent leaks across the blood brain barrier. A total of 80 subjects will be studied: 20 subjects with HIV that have not started highly active antiretroviral therapy (HAART) or that have been stable on a HAART regimen for at least four weeks; 20 subjects with HIV and a history of psychostimulant drug dependence; 20 HIV negative subjects with a history of psychostimulant drug dependence; and 20 normal controls. Each subject will be studied once. The MRI machine creates a strong magnetic field. If subjects have certain metal objects in their body, for example, metal fragments in the eye, non-removable hearing aids, nerve stimulators, or pacemakers, they would not be allowed to enter the magnet area and cannot participate in this study. Subjects may be bothered by feelings of claustrophobia (feeling enclosed) while in the scanner. Because the magnetic resonance imaging/magnetic resonance spectroscopy (MRI/MRS) scanner makes loud knocking noises, they are asked to wear earplugs. While the MRI/MRS makes the knocking noise, subjects might feel a tingling sensation in their arms or legs, but it is unlikely that this will occur. Subjects may become dizzy or experience a metallic taste in the mouth if they move the head quickly in the magnet. The radio waves produced by the scanner could cause a warm sensation, but this is unlikely. Although the long-term risk of exposure to the MRI/MRS machine is not known, there is no known long-term risk based on the information collected over the past 20 years. The major risk of the spinal tap is pain on the back where the spinal tap was done. Some individuals develop a headache that can last for days; prolonged headache develops in only 1 in 50 to 1 in 200 subjects. This headache is usually relieved with Tylenol (acetaminophen), drinking a lot of fluids, and lying flat. A persistent headache may result from continued spinal fluid leakage.
The effects of inserting needles to draw blood are usually some pain, bleeding and/or a bruise or swelling where the needle was inserted and on rare occasions, infection. Occasionally the area around the vein may swell. Any area where the skin anesthetic will be applied may become red and/or irritated. The neuropsychological testing and evaluation may make subjects feel uncomfortable. The risks of a gadolinium injection include discomfort and bruising at the site of puncture and, less commonly, the formation of a small blood clot or swelling of the vein and nearby tissue and bleeding from the puncture site. A small number of people have had bad reactions to the gadolinium contrast agent solution. Some of the bad reactions include headache, dizziness, metallic taste in mouth, nausea, and rash or hives. Death has been reported due to severe allergic reactions, but this has been an extremely rare occurrence with an estimated risk of 1 in 500,000. All records are confidential and may not be disclosed without the subject's written permission, except that the FDA and/or funding agencies may inspect the records.
"Attentional Modulation in Early Sensory Processing"
Principal Investigator: Dr. Thomas Ernst, Brookhaven National Laboratory
Project started in: 2001
This project ended in fiscal year 2004.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 05/20/03
Explanation of IRB approval:
Protocol was inactivated 04/13/04.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3
Reporting period for number of human subjects:
Other: 05/20/03 to 04/13/04
Explanation:
Protocol was inactivated 04/13/04.
Type(s) of Human Subjects Involvement:
The purpose of this study is to investigate the properties of basic sight and perception in humans using psychophysics and functional magnetic resonance imaging (fMRI). This will lead to a better understanding of visual attention and how attention can be affected. The first part of the study with involve psychophysics experiments at the University of Southern California (USC) to measure subjects ability to visually discriminate objects with small differences. They will perform these tasks for four to six weeks until they achieve a stable level of performance. The second part of the study will involve fMRI scans at Brookhaven National Laboratory (BNL) during which the subjects will perform the tasks they have practiced. Each subject will undergo four fMRI scans on two successive days. We plan to enroll 15 subjects at USC in order to select 10 to come to BNL for the fMRI part of the study.
The MRI machine creates a strong magnetic field. If subjects have certain metal objects in their body, for example, metal fragments in the eye, non-removable hearing aids, nerve stimulators, or pacemakers, they would not be allowed to enter the magnet area and cannot participate in this study. Subjects may be bothered by feelings of claustrophobia (feeling enclosed) while in the scanner. Because the magnetic resonance imaging/magnetic resonance spectroscopy (MRI/MRS) scanner makes loud knocking noises, they are asked to wear earplugs. While the MRI/MRS makes the knocking noise, subjects might feel a tingling sensation in their arms or legs, but it is unlikely that this will occur. Subjects may become dizzy or experience a metallic taste in the mouth if they move their head quickly in the magnet. The radio waves produced by the scanner could cause a warm sensation, but this is unlikely. Although the long-term risk of exposure to the MRI/MRS machine is not known, there is no known long-term risk based on the information collected over the past 20 years. All records are confidential and may not be disclosed without the subject's written permission, except that the FDA and/or funding agencies may inspect the records.
"Investigation of the "Early Response" in Functional MRI"
Principal Investigator: Dr. Thomas Ernst, Brookhaven National Laboratory
Project started in: 2001
This project ended in fiscal year 2004.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 05/20/03
Explanation of IRB approval:
Protocol was inactivated 04/13/04.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 9
Reporting period for number of human subjects:
Other: 05/20/03 to 04/13/04
Explanation:
Protocol was inactivated 04/13/04.
Type(s) of Human Subjects Involvement:
The purpose of this effort is to further study a small signal that can be detected with functional magnetic resonance imaging (fMRI) within 500 milliseconds after a stimulus (e.g., a flash of light). This small signal change is called the early response, which is different from the typical signal observed with standard fMRI techniques. Sixty healthy control subjects will be studied. For Phase I (technical development), twenty subjects will undergo one fMRI scan using a contrast agent. For Phase II (experimental phase), forty subjects will undergo two fMRI scans, one of which uses a contrast agent. During the scans, each subject will see occasional flashes of light through goggles. Each scan is expected to last one and a half hours. The MRI machine creates a strong magnetic field. If subjects have certain metal objects in their body, for example, metal fragments in the eye, non-removable hearing aids, nerve stimulators, or pacemakers, they would not be allowed to enter the magnet area and cannot participate in this study. Subjects may be bothered by feelings of claustrophobia (feeling enclosed) while in the scanner. Because the magnetic resonance imaging/magnetic resonance spectroscopy (MRI/MRS) scanner makes loud knocking noises, they are asked to wear earplugs. While the MRI/MRS makes the knocking noise, subjects might feel a tingling sensation in their arms or legs, but it is unlikely that this will occur. Subjects may become dizzy or experience a metallic taste in the mouth if they move the head quickly in the magnet. The radio waves produced by the scanner could cause a warm sensation, but this is unlikely. Although the long-term risk of exposure to the MRI/MRS machine is not known, there is no known long-term risk based on the information collected over the past 20 years. The effects of inserting needles to draw blood are usually some pain, bleeding and/or a bruise or swelling where the needle was inserted and on rare occasions, infection. Occasionally the area around the vein may swell. The risks of a gadolinium injection include discomfort and bruising at the site of puncture and, less commonly, the formation of a small blood clot or swelling of the vein and nearby tissue and bleeding from the puncture site. A small number of people have had bad reactions to the gadolinium contrast agent solution. Some of the bad reactions include headache, dizziness, metallic taste in mouth, nausea, and rash or hives. Death has been reported due to severe allergic reactions, but this has been an extremely rare occurrence with an estimated risk of 1 in 500,000. All records are confidential and may not be disclosed without the subject's written permission, except that the FDA and/or funding agencies may inspect the records.
"Precise In Vivo Measurement of Brain Metabolites"
Principal Investigator: Dr. Thomas Ernst, Brookhaven National Laboratory
Project started in: 2001
This project ended in fiscal year 2004.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 08/20/03
Explanation of IRB approval:
Protocol was inactivated 04/13/04.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2
Reporting period for number of human subjects:
Other: 08/20/03 to 04/13/04
Explanation:
Protocol was inactivated 04/13/04.
Type(s) of Human Subjects Involvement:
The purpose of this study is to design a new magnetic resonance (MR) technique to measure certain brain chemicals that are difficult to measure with standard techniques. In Phase I of this study, this technique will be developed and optimized in 20 healthy control subjects. Each subject will undergo one MRI session. In Phase II of this study, the optimized technique will be tested in both healthy controls and HIV positive subjects to understand the effects of HIV infection on brain chemistry. Twenty control subjects and 20 HIV infected subjects will undergo one MRI each. The MRI machine creates a strong magnetic field. If subjects have certain metal objects in their body, for example, metal fragments in the eye, non-removable hearing aids, nerve stimulators, or pacemakers, they would not be allowed to enter the magnet area and cannot participate in this study. Subjects may be bothered by feelings of claustrophobia (feeling enclosed) while in the scanner. Because the magnetic resonance imaging/magnetic resonance spectroscopy (MRI/MRS) scanner makes loud knocking noises, they are asked to wear earplugs. While the MRI/MRS makes the knocking noise, subjects might feel a tingling sensation in their arms or legs, but it is unlikely that this will occur. Subjects may become dizzy or experience a metallic taste in the mouth if they move their head quickly in the magnet. The radio waves produced by the scanner could cause a warm sensation, but this is unlikely. Although the long-term risk of exposure to the MRI/MRS machine is not known, there is no known long-term risk based on the information collected over the past 20 years. The effects of inserting needles to draw blood are usually some pain, bleeding and/or a bruise or swelling where the needle was inserted and on rare occasions, infection. Occasionally the area around the vein may swell. Any area where the skin anesthetic will be applied may become red and/or irritated. All records are confidential and may not be disclosed without the subject's written permission, except that the FDA and/or funding agencies may inspect the records.
"Brain Dopamine, Reward and Motivation in Obese Subjects With and Without a Binge Eating Disorder"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2002
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 12/17/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 13
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this study is to determine if dopamine is involved in the response to pleasurable, stressful or unpleasant food experiences in obese subjects. Twenty obese subjects with a binge eating disorder and 20 obese subjects without a binge eating disorder will be studied. First they will receive a dose of methylphenidate or a placebo. They will not know which they are receiving. Following the administration of methylphenidate or placebo, they will either see, smell, taste or be exposed to a variety of foods, or see, smell, taste or be exposed to things such as pictures, toys, clothing items or be asked questions that do not result in a strong emotional feeling or response. Following the behavioral intervention, they will undergo a position emission tomography (PET) scan. PET is a type of camera which will take pictures of the subject's brain. Each subject will be asked to return on a separate day to undergo the same procedure, but in reverse order as the first day.
Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. The effects of inserting needles to draw blood are usually some pain, bleeding and/or a bruise or swelling where the needle was inserted and on rare occasions, infection. Occasionally the area around the vein may swell. Any area where the skin anesthetic will be applied may become red and/or irritated.
A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. All records are confidential and may not be disclosed without the subject's written permission, except that the FDA and/or funding agencies may inspect the records.
"Imaging of Neuroendocrine Tumors Using PET (COMT)"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2002
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 02/21/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this study is to determine whether the radiotracers [18F]Ro41-0960 and [11C]clorgyline can be used with positron emission tomography (PET) to image a neuroendocrine tumor (NET). Five normal subjects and 20 subjects with NET that produce catecholamines (NETC) will have only one injection of [18F]Ro41-0960 with two whole body PET scans; one beginning at 60 minutes after radiotracer injection and the other about four hours after radiotracer injection. Twenty subjects with NET that produce serotonin (NETS) will have only one injection of [11C]clorgyline with only one whole body PET scan about 10 minutes after radiotracer injection. If the tumor(s) can be visualized after examining the data from the first whole body scan in the subjects with NET that produce catecholamines (NETC), it may not be necessary to perform the second whole body scan in some of these subjects. We shall evaluate the feasibility of using [18F]Ro41-0960 and [11C]clorgyline to visualize NETS in human subjects. NETS subjects who show a positive result from their [11C]clorgyline PET scan will be asked to return for two more PET scans: one with [11C]clorgyline; and the other with [11C]clorgyline-D. With this knowledge we can begin to devise effective approaches to treat and cure this devastating medical illness.
Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. All records are confidential and may not be disclosed without the subject's written permission, except that the FDA and/or funding agencies may inspect the records.
"Water Spaces in Leg Muscle Before and After Exercise"
Principal Investigator: Dr. William Rooney, Brookhaven National Laboratory
Project started in: 2002
This project ended in fiscal year 2004.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 01/21/03
Explanation of IRB approval:
Protocol was inactivated at its continuing review.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 01/21/03 to 12/18/03
Explanation:
Protocol was inactivated at its continuing review.
Type(s) of Human Subjects Involvement:
Water organization is profoundly affected by disease processes. Consequently, a technique for measuring water volumes could aid diagnosis and prognosis. We have developed a method which allows for non-invasive quantification of water fractions in vivo and one of the principal objectives of this study is to validate our approach in a well-characterized model where water volume fractions are known to change. Muscle is mostly water: 5 percent is in the bloodspace, 10 percent is in the space between cells, and the remaining 85 percent is found in the muscle cells themselves. During exercise these percentages change and we wish to measure this change. We will recruit five healthy controls and use magnetic resonance imaging (MRI) to measure muscle properties before and after exercise. Three subject visits are required. The first visit will be a screening visit including resting electrocardiogram (EKG) and blood sample to check kidney function. The second visit includes the MRI exam of the resting leg muscle, while the third visit includes the MRI exam of the working muscle. Both MRI exams require administration of a (FDA approved) contrast agent. Blood samples will be obtained during the second and third visits to measure hematocrit.
The MRI machine creates a strong magnetic field. If subjects have certain metal objects in their body, for example, metal fragments in the eye, non-removable hearing aids, nerve stimulators, or pacemakers, they would not be allowed to enter the magnet area and cannot participate in this study. Subjects may be bothered by feelings of claustrophobia (feeling enclosed) while in the scanner. Because the magnetic resonance imaging/magnetic resonance spectroscopy (MRI/MRS) scanner makes loud knocking noises, they are asked to wear earplugs. While the MRI/MRS makes the knocking noise, subjects might feel a tingling sensation in thgeir arms