Ms. Mona
Rowe
Brookhaven National Laboratory
Building 400
Upton, NY 11973-5000
Phone: 631-344-5056
Fax: 631-344-3368
E-mail: mrowe@bnl.gov
Number of Human Subjects projects reported: 42
| 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" |
| BNL-99-302 | "Dopaminergic Brain Function in Alcoholics: Response to Methylphenidate Challenge" |
| BNL-00-328 | "Perception of Pleasure and Control of Behavior in Drug Addiction: An fMRI Study" |
| BNL-01-352 | "PET Studies of Cocaine Abuse: Effects of Expectation" |
| BNL-01-353 | "PET Studies in Attention Deficit Disorder: Role of Dopamine" |
| 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-02-367 | "Heavy Ion Induced Chromosome Damage and Biomedical Countermeasures" |
| BNL-02-369 | "Clinical Correlates of Longitudinal PET Changes in Alzheimer's Disease (AD): A Glucose Challenge Study" |
| BNL-02-370 | "Imaging of Brain Metabolic Responses to Food Presentation" |
| BNL-02-371 | "Botulinum Toxoid Immunization" |
| 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-03-381 | "Brain Metabolic Response to Images of Violent Behavior" |
| BNL-03-385 | "Monoamine Oxidase (MAO) Genetics and Brain Function" |
| BNL-03-387 | "Acoustic Interference on Attention " |
| BNL-03-388 | "Measurement of Dopamine Systems in Subjects At-Risk for Alcoholism" |
| BNL-03-389 | "Influence of the Shielding on the Space Radiation Biological Effectiveness" |
| BNL-03-390 | "Brain Dopamine Function in Adults with ADHD" |
| BNL-04-394 | "Brain Metabolic Response to Satiety Control: Effects of Implantable Gastric Stimulation (IGS)" |
| BNL-04-399 | "Imaging of Brain Metabolic Response to Mathematical Task" |
| BNL-05-400 | "The Role of Gastric Distention in Eating Behavior" |
| BNL-05-401 | "Cerebral Language Organization in Children with Autism Spectrum Disorders - an fMRI Study of Dichotic Listening" |
| BNL-05-404 | "Brain Metabolic Responses to Cocaine Cue in Cocaine Users" |
| BNL-05-410 | "The Role of Norepinephrine Transporter (NET) in Stimulants" |
| BNL-05-411 | "SND 103190: An Open-Label, Randomized PET Study in Healthy Male Volunteers Consisting of Part A and Part B" |
| BNL-06-393 | "Non-Invasive Blood Radioactivity Monitor" |
| BNL-06-413 | "Imaging Insulin Resistance in Obesity" |
| BNL-06-414 | "Neurogenetics of Inhibitory Control" |
| BNL-06-415 | "Ovarian Hormone Modulation of Intracranial Pressure (ICP): MR Study" |
| BNL-06-416 | "PET Study of Retinal Prothesis Functionality" |
| BNL-06-417 | "Acoustic Interference on Attention in Cocaine Abusers" |
| BNL-06-418 | "Novel Multi-Modality MRI and Transcranial Magnetic Stimulation to Study Brain Connectivity" |
| BNL-06-419 | "PET Studies of Modafinil (Provigil)" |
| BNL-06-420 | "PET Studies of the Pharmacokinetics of d-Methamphetamine in the Human Body" |
| BNL-07-421 | "PET Studies of Sleep Deprivation" |
| BNL-07-422 | "Genomics of Brain Structure and Function" |
| BNL-07-423 | "N-Methyl-D-Aspartate (NMDA) Receptor in Alzheimer's Disease" |
| BNL-07-424 | "PET Imaging of Brain Metabolic Responses to Low-Field Magnetic Stimulation Using 4T MR" |
| BNL-07-427 | "Norepinephrine Transporter (NET) Blockade by Low Dose Atomoxetine" |
| BNL-07-428 | "The Effect of CX157 on the Inhibition of Brain MAO-A Using PET in Healthy Normal Volunteers" |
"General Magnetic Resonance Imaging (MRI) and Spectroscopic (MRS) Studies of Human Subjects"
Principal Investigator: Dr. Dardo Tomasi, Brookhaven National Laboratory
Project started in: 1996
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: Stony Brook University
Most recent approval: 05/02/07
IRB approval number: 20076190
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 8
Reporting period for number of human subjects:
Year prior to last IRB approval date
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 Food and Drug Administration (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"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 1999
Status of the Research this Fiscal Year:
Study enrollment is permanently closed, participants have completed research-related interventions, and long-term follow-up is completed. The remaining research activities are limited only to data analysis.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Stony Brook University
Most recent approval: 08/08/07
IRB approval number: 20073514
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:
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, 16 non-alcoholic subjects, and 40 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 Food and Drug Administration (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.
"Dopaminergic Brain Function in Alcoholics: Response to Methylphenidate Challenge"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 1999
Status of the Research this Fiscal Year:
Study enrollment is permanently closed, participants have completed research-related interventions, and long-term follow-up is completed. The remaining research activities are limited only to data analysis.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Stony Brook University
Most recent approval: 09/05/07
IRB approval number: 20074090
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:
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 Food and Drug Administration (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.
"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
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: Stony Brook University
Most recent approval: 03/05/07
IRB approval number: 20076133
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 41
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The goal of the present research is to evaluate human brain function implicated in the perception of pleasure and control of behavior by functional magnetic resonance imaging (fMRI) recordings and behavioral assessment, cognitive event related potential (ERP) testing, and other physiological (e.g., skin conductance responses) and behavioral (neuropsychological) testing. 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 the possibility of timely intervention and prevention of drug addiction. The human brain mapping will be obtained using a 4 Tesla (4T) magnetic resonance imaging (MRI) scanner with presentations of visual and/or auditory stimuli to subjects in the scanner. Electrophysiological (ERP) data will be acquired outside the MRI environment using NeuroScan 64-channel equipment. No radiopharmacueticals or surgical procedures will be used in this study. Oral methylphenidate is administered to enhance resolution in this research. 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 or ERP testing. 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; no risk larger than minimal has been identified with ERP testing. All records are confidential and may not be disclosed without the subject's written permission with the exception that the Food and Drug Administration (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 Cocaine Abuse: Effects of Expectation"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2001
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: Stony Brook University
Most recent approval: 03/08/07
IRB approval number: 20076131
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 when cocaine abusers are expecting to receive the drug versus when they are not, and to assess if expectation can activate a similar circuit to that activated by the drug 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 complete studies in a total of 96 (n=96) subjects: 48 subjects for Study Part 1A and 48 subjects for Study Part 1B. For Study Part 1A, subjects will have four fluorodeoxyglucose-positron emission tomography (FDG-PET) scans, each one on a different day. For Study Part 1B, subjects will have four raclopride PET scans, two of each on two days of study. 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 Food and Drug Administration (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
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Stony Brook University
Most recent approval: 01/09/07
IRB approval number: 20076074
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:
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, dopamine receptors, and dopamine itself). We will complete studies in no more than 50 subjects: 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 Food and Drug Administration (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
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: Stony Brook University
Most recent approval: 01/09/07
IRB approval number: 20076072
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 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 uses a type of camera which takes 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 Food and Drug Administration (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
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Stony Brook University
Most recent approval: 04/05/07
IRB approval number: 20076181
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:
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 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 Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Heavy Ion Induced Chromosome Damage and Biomedical Countermeasures"
Principal Investigator: Dr. Francis Cucinotta, NASA Johnson Space Center
Project started in: 2002
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Stony Brook University
Most recent approval: 03/28/07
IRB approval number: 20076086
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 the effect of radiation on chromosomes. Blood samples will be drawn from subjects several hours before irradiating these samples at the NASA Space Radiation Laboratory (NSRL) at BNL. Whole blood will be exposed to ions at various doses up to 1.5 Gy. After irradiation, lymphocytes will be stimulated to grow in culture and incubated. Samples will be collected after chromosomes are forced to condense in both the interphase and metaphase stages of the cell cycle. Chromosome damage will be assessed using fluorescence markers for individual chromosomes. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of 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 Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Clinical Correlates of Longitudinal PET Changes in Alzheimer's Disease (AD): A Glucose Challenge Study"
Principal Investigator: Dr. Mony J. de Leon, NYU School of Medicine
Project started in: 2002
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Stony Brook University
Most recent approval: 04/18/07
IRB approval number: 20076130
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 examine the effects of higher than normal levels of glucose (sugar) on cognitive performance (mental activity) and on glucose metabolism in the brain. A specific goal is to try to understand whether abnormal glucose metabolism may underlie the memory loss that occurs in Alzheimer's disease. Brain glucose metabolism will be measured using a positron emission tomography (PET) scan. PET is a type of camera that takes pictures of the subject's brain. Each PET scan will involve the administration of the radiotracer 18-fluorodeoxyglucose (18FDG). A radiotracer is a radioactive chemical that is injected into the bloodstream in very small amounts. Each subject will be scanned twice: once with and once without the administration of glucose. Eight control subjects and eight subjects with early Alzheimer's Disease will be studied and compared.
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 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. There should be no risk associated with the amount or time of glucose infusion. However, if glucose is infused too quickly it can leak through the vein and form a lump in the vein and/or cause a burning sensation. Infusing glucose too quickly could also cause mental confusion and/or loss of consciousness. 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 Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Imaging of Brain Metabolic Responses to Food Presentation"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2002
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: Stony Brook University
Most recent approval: 03/08/07
IRB approval number: 20076132
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:
The purpose of this study is to compare the effect of behavioral and neutral stimulation on brain glucose metabolism. Brain glucose metabolism will be measured using a positron emission tomography (PET) scan. PET is a type of camera that takes pictures of the subject's brain. Each PET scan will involve the administration of the radiotracer 18-fluorodeoxyglucose (18FDG). A radiotracer is a radioactive chemical that is injected into the bloodstream in very small amounts.
Study #1A, Specific Aim 1: We will evaluate brain glucose metabolic activity in 20 normal control subjects under food, neutral, and baseline interventions. We hypothesize that frontal (orbitofrontal cortex, OFC), parietal (somatosensory cortex), and hypothalamic metabolism will be significantly increased in food presentation when compared to neutral/baseline (no intervention) conditions. We also hypothesize that parietal (somatosensory cortex) metabolism will be significantly increased in neutral stimulation when compared to baseline condition.
Study #1B, Specific Aim 1: We will evaluate brain glucose metabolic activity in 20 normal control subjects under the food desire, attempted inhibition, and baseline interventions. We hypothesize that metabolism in the superior frontal gyrus and anterior cingulate gyrus will be significantly increased and orbitofrontal metabolism will be decreased in the attempted inhibition when compared to food desire conditions. We hypothesize that parietal (somatosensory cortex), orbitofrontal, and insular metabolism will be significantly increased in food desire condition when compared to baseline condition. We also hypothesize the association of emotion (i.e., decreased food desire) with increased metabolic change in anterior cingulate gyrus. Forty control subjects will be studied.
Study 1C: We will evaluate brain glucose metabolic activity in 24 normal control female subjects of childbearing potential under the food desire and attempted inhibition during mid-follicular (4 to 8 days after the onset of menses) and luteal (6 to 10 days after the luteinizing hormone surge as determined by urinary luteinizing hormone essay) phases of the menstrual cycle. We hypothesize that during the luteal phase there will be increased metabolism in striatum and orbitofrontal cortex compared to the mid-follicular phase. We also hypothesize that cognitive inhibition will decrease metabolic activity in amygdala, hippocampus, and striatum during mid-follicular phase but not during luteal phase.
Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of 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. 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 Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Botulinum Toxoid Immunization"
Principal Investigator: Dr. Joseph P. Falco, Brookhaven National Laboratory
Project started in: 2002
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Stony Brook University
Most recent approval: 01/04/07
IRB approval number: 20076059
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:
This study's purpose is to prevent Botulism (reaction to toxin) in employees working with Botulinum toxin by administration of Botulinum toxoid. There are three subjects participating in this study. Subjects will be given injections at 0, 2, and at 12 and 24 weeks. The first booster will be given 12 months after the initial series. Subsequent booster injections are given at one-year intervals.
"Methamphetamine Effects in Brain Dopamine Activity"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2002
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: Stony Brook University
Most recent approval: 08/24/07
IRB approval number: 20074835
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 6
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
PART 1: We will use positron emission tomography (PET) and the radiotracer [11C]raclopride to assess the test/retest reproducibility for the measures of dopamine changes in five normal controls with PET and raclopride with and without pretreatment of oral methylphenidate at baseline and again within a one-month period.
PART 2: In this part of the study, we will investigate how much damage methamphetamine (METH) does to the human brain and to evaluate whether the brain can recover with detoxification from METH after a drug-free period of about six to nine months. We will use [11C]cocaine to measure dopamine transporter levels and [11C]raclopride to measure dopamine cell function by comparing the binding of [11C]raclopride with and without pretreatment or oral methylphenidate. A magnetic resonance imaging (MRI) scan will be obtained in this part of the study to correct for potential brain deterioration in the subjects, and this will be repeated on the return visit six to nine months later. We want to test 40 METH abusers over a four-year period during early withdrawal (between two weeks and three months of last METH use) and then retest them six to nine months after a drug-free period. Twenty normal controls will be tested in parallel and ten of them will be retested six to nine months later.
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. Since methylphenidate will be administered orally, the likelihood of cardiac stimulation is lower. 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.
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 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 Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Clinical Correlates of Longitudinal PET Changes in Normal Aging, Mild Cognitive Impairment and Alzheimer's Disease"
Principal Investigator: Dr. Mony J. de Leon, New York University School of Medicine
Project started in: 2002
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: Stony Brook University
Most recent approval: 04/25/07
IRB approval number: 20076198
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 33
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 identify the earliest indicators of memory and brain changes in normal aging which predict the change to mild cognitive impairment or Alzheimer's Disease. The study will examine how areas of the brain that are related to memory functioning use sugar which is fuel for the brain. The study will use positron emission tomography (PET) which is a special camera that takes pictures of the movement of a radiotracer in the brain. A radiotracer is a radioactive chemical that is injected into the bloodstream in very small amounts. Three groups will be studied. Group 1: 35 healthy 50 to 90 year old subjects with an observed memory decline; Group 2: 35 healthy 50 to 90 year old subjects without a history of memory decline; and Group 3: 25 healthy 20 to 40 year old control subjects. Over 36 months, Groups 1 and 2 will receive three clinical evaluations with magnetic resonance imaging (MRI) and PET imaging. These will be obtained twice, once at the start of the study and again 36 months later. The control group will be studied only once.
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 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 Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Brain Metabolic Response to Images of Violent Behavior"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2003
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: Stony Brook University
Most recent approval: 06/28/07
IRB approval number: 20076288
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
Part l: The purpose of this part is to determine if chemicals in the human brain change when subjects either watch a violent video or a neutral video as compared to when they do not. Twenty-four male subjects will have three positron emission tomography (PET) scans with a tracer that will be performed on three different days to assess the effect of no intervention (baseline scan), behavioral (violent video presentation), and neutral (neutral video presentation) interventions on brain glucose metabolism. Subjects will also receive a fourth PET scan using [11C]DASB which can occur on the same day as any 18FDG scan or a different day. The radiotracer for this study is 18-fluorodeoxyglucose (18FDG), which is a radioactive sugar that is injected into the bloodstream in very small amounts and serves as an indicator of brain function. If subjects have the [11C]DASB scan on the same day as an 18FDG scan, it will be done first. PET is a special camera that takes pictures of the movement of a radiotracer in the body.
Part 2: The purpose of this part is to measure levels of serotonin in the brain and compare it to levels of serotonin in saliva. We will also analyze levels of monoamine oxidase, subtype A (MAO A) secondarily to see if we can associate those results with other measures that we obtain in this study. Both serotonin and the MAO transporter are involved in the regulation of mood and behavior. Results of genotyping of serotonin and the MAO A transporter do not predict any disease susceptibility or disorder, just the presence of either long or short serotonin or high or low MAO A transporter levels. One PET scan with a radiotracer will be administered. The radiotracer for this study is [11C]DASB, which is injected into the bloodstream in a small amount and serves as an indicator of serotonin transporter levels.
We will also perform two separate functional magnetic resonance imaging (fMRI) scans in subjects who meet criteria, which will allow us to simultaneously record brain activity to paradigms that involve emotional processing and behavioral regulation. In addition, for subjects who give their informed consent, we would like to obtain genetic samples in the form of cheek swabs to perform genotyping of MAO A and the serotonin transporter genes in order to possibly determine a correlation between genetic results and metabolic responses to video stimulation.
Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of 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 or become red 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. 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 Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Monoamine Oxidase (MAO) Genetics and Brain Function"
Principal Investigator: Dr. Joanna Fowler, Brookhaven National Laboratory
Project started in: 2003
Status of the Research this Fiscal Year:
Study enrollment is permanently closed, participants have completed research-related interventions, and long-term follow-up is completed. The remaining research activities are limited only to data analysis.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Stony Brook University
Most recent approval: 06/18/07
IRB approval number: 20076279
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:
The purpose of this study is to determine whether subjects who have a high or low monoamine oxidase (MAO A) genotype also have high or low levels of brain MAO A. MAO is an enzyme that breaks down neurotransmitters, such as dopamine, serotonin, and norepinephrine, which are involved in the regulation of mood and behavior. Understanding this relationship between MAO A genotype and levels of brain MAO A is important because it is a first step in understanding the relationship of genes to behavior. Subjects will receive two positron emission tomography (PET) scans on the same day, each one with a different radiotracer. The radiotracers we will use for this study are [11C]clorgyline and 18-fluorodeoxyglucose (18FDG). In addition, we would also like to determine the functional significance of this genotype by conducting functional magnetic resonance imaging (fMRI) and neuropsychological tests, which can tell us how brain function is related to behavior, thought processes, and emotion. We will complete the study using 30 healthy control subjects.
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 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. 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 Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Acoustic Interference on Attention"
Principal Investigator: Dr. Dardo Tomasi, Brookhaven National Laboratory
Project started in: 2003
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Current study is completed.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Stony Brook University
Most recent approval: 03/27/06
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:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this study is to evaluate how acoustic noise interferes with brain activity in healthy subjects and patients infected with the human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). Under noisy conditions, brain function requiring attention or memory may become more difficult due to the loss of concentration induced by the acoustic interference. This interference can be stronger in patients with AIDS, because HIV has already caused injury to the nervous system. The findings from this study will demonstrate how louder noise might affect cognitive function, for both men and women as related to gender differences, and help guide future comparisons between functional magnetic resonance imaging (fMRI) studies performed at different magnetic field strengths. The subject population for this study will involve two groups: a) seronegative control subjects and b) HIV-seropositive men with early stages of HIV dementia.
Neuroimaging data will be acquired using a whole body 4 Tesla magnetic resonance imaging (MRI) scanner, which is considered a "minimal risk device" by the Food and Drug Administration (FDA). 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) machine 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 major risk of the spinal tap is pain in 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. 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.
"Measurement of Dopamine Systems in Subjects At-Risk for Alcoholism"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2003
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: Stony Brook University
Most recent approval: 07/25/07
IRB approval number: 20075905
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 purpose of this study is to examine levels of dopamine (DA) and brain glucose function in people who are at a high risk (HR) for alcoholism. We will compare the results we obtain with those of low risk (LR) subjects. People who have a biological father and at least two relatives who are or were alcoholics are considered at HR for alcoholism. People who have no family history of alcoholism are considered LR for alcoholism. It is thought that low dopamine levels and low brain glucose function may be an inherited vulnerability factor for alcoholism, which may make some HR people more susceptible to becoming alcoholics; whereas higher levels of dopamine and brain glucose function may be an inherited protective factor for alcoholism, which may be what is preventing some HR people from becoming alcoholics.
Dopamine and brain glucose function will be measured with positron emission tomography (PET) scans in 120 subjects over the next five years. PET is a special camera that takes pictures of the movement of a radiotracer in the brain. Radiotracers are radioactive chemicals that are injected into the bloodstream in very small amounts in order to show levels of dopamine and brain sugar. Sixty HR and sixty LR subjects will have two PET scans performed preferrably on the same day of study. One PET scan will be done to measure dopamine levels, and the other PET scan will be done to measure sugar levels in areas of their brains during a normal state. Subjects will also have a magnetic resonance imaging (MRI) scan performed to compare these results.
MRI is an imaging system that uses a strong magnet and radiowaves to generate pictures of the body. 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.
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 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. Alcohol impairs motor coordination and subjects will not be permitted to drive or perform any activity that requires motor skills on the day of the study. It can cause nausea and/or vomiting. Also, the use of alcohol with other drugs may be dangerous and subjects must not take any other drugs within a week of the 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 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. 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 Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Influence of the Shielding on the Space Radiation Biological Effectiveness"
Principal Investigator: Dr. Marco Durante, Universita Federico II, Naples, Italy
Project started in: 2003
This is an international project.
Foreign Subjects Yes
Foreign Data Yes
Foreign Specimens Yes
Foreign Collaborators Yes
Foreign IRB No
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Stony Brook University
Most recent approval: 08/13/07
IRB approval number: 20075888
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement: