Ms. Kathy S. Burrows
801 University Blvd SE
Suite 200
Albuquerque, NM 87106
Phone: 505-272-7578
Fax: 505-272-7574
E-mail: kburrows@unm.edu
Number of Human Subjects projects reported: 21
| MIND-99-UNM HRRC 00-328 | "A MEG and fMRI Study of How the Brain Processes Time" |
| MIND-02-MGH 1999-P-008666/19 | "Toward the prevention of schizophrenia: Neurobiological studies of families with schizophrenia" |
| MIND-02-MGH 2001-P-000257/6 | "Functional and structural neuroimaging studies of higher cognitive function in schizophrenia" |
| MIND-02-MGH2001-P-001059/1 | "Executive inhibitory processes in neuropsychiatric disorders of childhood. " |
| MIND-02-MGH2002-P-00580/1 | "Multimodality imaging of cognitive processes in normal subjects" |
| MIND-02-MGHMcCarley | "First episode schizophrenia: an ERP and MEG longitudinal study" |
| MIND-02-Minn 0104M95501 | "MRS assessment of glutamate in young patients with schizophrenia" |
| MIND-02-Minn 0109M07887 | "Genomics and white matter abnormalities in schizophrenia." |
| MIND-02-Minn VAMC 2896 | "The neural network of auditory verbal hallucinations" |
| MIND-02-Minn0006M55421 | "fMRI studies of single-noun processing in schizophrenia" |
| MIND-02-Minn005M50901 | "MEG of visual attention deficits in schizophrenia" |
| MIND-02-Minn0205M25581 | "fMRI Study of Spatial Memory in Adolescents with Schizophrenia" |
| MIND-02-MinnVA 2778 | "Dynamic study of rapid semantic priming in schizophrenia" |
| MIND-02-MinnVA2772 | "Ultru high field fMRI and MEG for praxis" |
| MIND-02-NMVA HRRC 02-076 | "Initial Efficacy Study of a New Whole-Head Magnetoencephalograpy System" |
| MIND-02-UNM HRRC 02-051 | "Longitudinal assessment brain neurochemistry early in schizophrenia with high-field proton spectroscopy as a predictor of functional deterioration." |
| MIND-02-UNM HRRC 02-220 | "Brain Morphology and neurochemistry in child and adolescent onset schizophrenia" |
| MIND-02-UNM HRRC 99-336 | "Sensory gating and working memory in schizophrenia" |
| MIND-02-UNM HRRC02-075 | "Functional MRS of the normal brain." |
| MIND-02-UNM-HRRC 01-537 | "Dynamic Systems Mediating Verbal and Spatial Working Memory Tasks as Characterized by MEG" |
| MIND-02-UNM-HRRC 20-287 | "MEG Studies of Temporal Information Processing in Normal Subjects" |
"A MEG and fMRI Study of How the Brain Processes Time"
Principal Investigator: Dr. Deborah Harrington, MIND Institute
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: UNM
Most recent approval: 08/19/02
IRB approval number: HRRC 00-328
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 41
Reporting period for number of human subjects:
Other: 01/01/02 to 12/31/02
Explanation:
MIND Institute fiscal year
Type(s) of Human Subjects Involvement:
Objectives: The mechanisms by which the brain times events and stores them in memory for later use is of great interest. The purpose of this research is to use magnetoencephalography (MEG) and functional magnetic resonance imaging (fMRI) to study the brain systems that control our ability to perceive and remember the amount of time that has passed. The working hypothesis is that the basal ganglia regulate the "timekeeper" mechanism.
Methodology: see above
Exposure to Ionizing Radiation, Radioactive Substances, and Chemical Substances:
Not applicable
Involvement of Human Subjects:
Procedures involving Human Subjects: Subjects will be asked to perform a variety of tasks to assess the ability to distinguish different intervals of time and different pitches of sound. These involve listening to sounds through earphones and then pressing a button on a keyboard or lifting a finger. These tasks will be performed while the subject is undergoing MEG and the fMRI.
Risks: Subjects will need to lie still in the MRI machine during testing. This test will take up to 90 minutes. Subjects will be given breaks at regular intervals. The MRI machine makes a loud banging noise. Efforts to make subjects comfortable will be made including providing earplugs or other support. Patients with pacemakers, metal in their body, aneurysm clips, ear implants or nerve stimulators will not be able to participate in this study. Pregnant women will also be excluded from participation in this study. All subjects may withdraw from the study at any time without consequence.
Privacy/Confidentiality/Consent: The study records may be made available to the Food and Drug Administration and the University of New Mexico Research and Review Committee. Otherwise, subject records will be kept strictly confidential.
"Toward the prevention of schizophrenia: Neurobiological studies of families with schizophrenia"
Principal Investigator: Dr. Ming T. Tsuang, MIND Institute
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: MGH
Most recent approval: 05/07/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 16
Reporting period for number of human subjects:
Other: 01/01/02 to 12/31/02
Explanation:
MIND Institute fiscal year
Type(s) of Human Subjects Involvement:
Objectives: To better identify the neural substrate of schizophrenia by identifying subsyndromal phenomenology that may be transmitted in persons at risk for this illness. This study will focus on temporal-limbic brain regions and their pre-frontal connections that have been identified previously as critical in understanding the nature of schizophrenia. A second aim is to identify the specificity of these hypotheses for schizophrenia compared with persons with bipolar psychotic disorders.
Methodology: 24 persons in each group will be studied and 50normal controls for a total of 146 subjects over 3 years. Subjects will be given diagnostic interviews and cognitive testing to assess IQ, attention, working and declarative memory, executive function, language domains and motor function. Patients will then participate in functional and structural imaging procedures.
Exposure to Ionizing Radiation, Radioactive Substances, and Chemical Substances:
Not applicable
Involvement of Human Subjects:
Procedures involving Human Subjects: Subjects will be recruited from local hospital clinics and consumer groups (NAMI). Subjects will give written, informed consent. Subjects will undergo cognitive testing and MRI procedures.
Risks: Subjects may become bored or fatigued during testing. All subjects will be given numerous breaks. All subjects are free to withdraw at any time without consequence.
Privacy/Confidentiality/Consent: Study information will be kept confidential to the extent allowed by law. The FDA and sponsor of the study may access study records. In publications resulting from the study no names will be used.
"Functional and structural neuroimaging studies of higher cognitive function in schizophrenia"
Principal Investigator: Dr. Stephan Heckers, MIND Institute
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: MGH
Most recent approval: 03/06/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 60
Reporting period for number of human subjects:
Other: 01/01/02 to 12/31/02
Explanation:
MIND Institute fiscal year
Type(s) of Human Subjects Involvement:
Objectives: These projects will investigate the cognitive and neuropsychological basis of deficits in higher cognitive function in schizophrenia using structural and functional neuroimaging techniques. Others and we have established that schizophrenic patients show specific and selective deficits in working memory, declarative memory and language function. This study will use new methods for the acquisition and analysis of functional and structural data sets, using fMRI, MEG and cortical flat mapping techniques.
Methodology: This study consists of six functional neuroimaging experiments. Men and women aged 18-55, right-handed and with a normal verbal IQ will be studied. Schizophrenic subjects will be recruited as outpatients and must meet inclusion criteria consisting of being on a stable dose of antipsychotic medication for at least 6 weeks or unmedicated, no substance abuse, and ability to give informed consent. Subjects will be given rating scales to assess symptoms (SANS, SAPS, Simpson-Angus, GAS, AIMS, and BPRS).
Exposure to Ionizing Radiation, Radioactive Substances, and Chemical Substances:
Not applicable
Involvement of Human Subjects:
Procedures involving Human Subjects: Subjects will be recruited and given a series of neuroimaging procedures including fMRI and MEG.
Risks: The risks are minimal as both procedures are non-invasive. Subjects will be given many breaks ad may withdraw at any time without consequence.
Privacy/Confidentiality/Consent: Subjects must provide written, informed consent. All information will be kept confidential. The FDA and sponsor of this study may access study files. Any publications resulting from this study will not mention any names.
"Executive inhibitory processes in neuropsychiatric disorders of childhood."
Principal Investigator: Dr. Kristina T. Ciesielski, MIND Institute
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: MGH
Most recent approval: 10/15/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 14
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
Objectives: The goal is to develop complementary fMRI and MEG cognitive paradigms that dissociate involvement of frontal-striatal and frontal-cerebellar brain subsystems with a view toward developing a diagnostic aid for childhood-onset disorders such as OCD and schizophrenia. These subsystems are sensitive to developmental changes and to deficits in executive inhibitory control (the ability to suppress irrelevant thoughts and behaviors), which is secerely abnormal in psychopathological entities such as OCD and schizophrenia. The study will be conducted in two parts: the first part will focus on the investigation of functional and anatomical aspects of the two brain subsystems underlying executive inhibitory control in typically developing healthy children. These data will provide a foundation of normal activity of brain subsystem component involvement, and will be used to validate the degree to which our cognitive paradigms dissociate involvement of the frontal-striatal and frontal-cerebellar subsystems in executive inhibitory control tasks. The second part of the study will initiate at the end of 2002. It will focus on application and comparison of the cognitive paradigm in children diagnosed with OCD. Considering that behavioral and neuroimaging measures of executive inhibitory control may serve as a marker of developmental progress in the frontal brain subsystems in a normal brain, these measures may also capture the early abnormalities in neuropsychiatric disorders that have been linked to frontal brain pathology, such as OCD and schizophrenia. The results of both studies combined are expected to elucidate both structural and functional markers for the chronologic and ontogenetic development of frontal brain subsystems in healthy normal children, as well as children with OCD and children at risk for schizophrenia.
Methodology: Investigators will use MEG and fMRI to record brain activity during a modified working memory task (n-back task).
Exposure to Ionizing Radiation, Radioactive Substances, and Chemical Substances:
Not applicable
Involvement of Human Subjects
Procedures involving Human Subjects: All subjects will give written informed consent prior to any study procedures. Subjects will undergo MEG and fMRI measures and a specialized working memory task.
Risks: Risk is minimal as both procedures are non-invasive. Subjects may become bored or fatigued and will be given numerous breaks to avoid both. All subjects are free to withdraw at any time without consequence.
Privacy/Confidentiality/Consent: Study information will be kept confidential to the extent allowed by law. The FDA and sponsor of the study may access study records. In publications resulting from the study no names will be used.
"Multimodality imaging of cognitive processes in normal subjects"
Principal Investigator: Dr. Caroline West, MIND Institute
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: MGH
Most recent approval: 05/22/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 44
Reporting period for number of human subjects:
Other: 01/01/02 to 12/31/02
Explanation:
MIND Institute fiscal year
Type(s) of Human Subjects Involvement:
Objectives: The overall goal is to further understand the neural bases of human cognitive processes in health and disease. A full appreciation of the complex mechanisms that underlie normal cognition is essential to the understanding of cognitive dysfunction. We propose a set of studies in normal subjects to investigate several basic functions known to be disrupted in a number of neurocognitive disorders, particularly schizophrenia. These experiments in normal subjects are a necessary prelude to studies in patient populations. The research described here employs the multi-modal neuroimaging approach developed at MGH. This methodology allows the investigators to explore the localization of cognitive processing mechanisms in the brain, but also to ask questions regarding the time course of those activations. The dynamic spatiotemporal maps of activation that will be obtained from these studies should greatly enhance the understanding of these fundamental cognitive operations. Specifically the investigators seek to 1) Reveal whether there are independent mismatch negativity generators (MMN) in the vicinity of the auditory cortex and whether the MMN can be explained by the effects of lateral inhibition on the N1 component, 2) Identify the spatiotemporal characteristics of attentional processing of novel auditory and visual stimuli, 3) Identify the origin of top-down facilitation in visual object recognition and 4) Characterize the dynamic structural and functional organization of semantic representations and processing mechanisms.
Methodology: Subjects will undergo fMRI, MEG and EEG measures.
Exposure to Ionizing Radiation, Radioactive Substances, and Chemical Substances:
Not applicable
Involvement of Human Subjects:
Procedures involving Human Subjects: Subjects will have MRI, MEG and EEG measures.
Risks: there is little risk associated with these non-invasive procedures. Persons who should not have MRI scanning will be excluded from the study. These include pregnant women, persons with ear implants or nerve stimulating devices, pacemakers and aneurysm clips.
Privacy/Confidentiality/Consent: All subjects must give written, informed consent prior to study participation. All study records will be kept confidential. The FDA and the study sponsor may access these records. In any publications resulting from this study, names will not be used.
"First episode schizophrenia: an ERP and MEG longitudinal study"
Principal Investigator: Dr. Robert W. McCarley, MIND Institute
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: MGH
Most recent approval: 01/29/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 30
Reporting period for number of human subjects:
Other: 01/01/02 to 12/31/02
Explanation:
MIND Institute fiscal year
Type(s) of Human Subjects Involvement:
Objectives: One of the central questions in schizophrenia is to what extent brain abnormalities occur peri-natally and to what extent these abnormalities occur, or progress, even after the onset of symptoms. This question has been variously posed as a "two-hit" model or as a developmental vs. degenerative model, although it is apparent that the mechanisms leading to early developmental abnormalities might also lead to continued alterations after symptom onset. It is also not known whether brain changes occurring after symptom onset might be ameliorated or even halted through proper neuroleptic and psychosocial interventions. To address these important issues, the investigators propose a longitudinal evoked potential study of first episode (hospitalization) schizophrenic and affective psychosis patients, to be followed up as intervals of 1.5 years. Key measures will be EEG, MEG, and MMN recordings.
Methodology: Subjects will be screened for inclusion/exclusion criteria. These include an IQ above 75, no alcohol or drug dependence or abuse within the last year, no hearing impairments. Subjects will then be evaluated with diagnostic tools (structured clinical interviews). Clinical measures will include the SANS, SAPS, BPRS, and TDI. Subjects will also administered EEG, MEG, and MRI measures.
Exposure to Ionizing Radiation, Radioactive Substances, and Chemical Substances:
Not applicable
Involvement of Human Subjects:
Procedures involving Human Subjects: Subjects will undergo procedures mentioned above. Subjects will provide written, informed consent prior to any study procedures.
Risks: Subjects may become bored or fatigued during testing. All subjects will be given numerous breaks. All subjects are free to withdraw at any time without consequence.
Privacy/Confidentiality/Consent: Study information will be kept confidential to the extent allowed by law. The FDA and sponsor of the study may access study records. In publications resulting from the study no names will be used.
"MRS assessment of glutamate in young patients with schizophrenia"
Principal Investigator: Dr. Charles Schulz, MIND Institute
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: UMN
Most recent approval: 04/18/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 11
Reporting period for number of human subjects:
Other: 01/01/02 to 12/31/02
Explanation:
MIND Institute fiscal year
Type(s) of Human Subjects Involvement:
Objectives: The glutamatergic system has been directly and indirectly implicated in schizophrenia from postmortem and functional imaging research. The functional imaging studies from the investigators indicate that the anterior cingulate cortex shown increased rCBF in response to ketamine, and is the region where symptoms and rCBF correlate in response to ketamine administration. Several laboratories have studied glutamate and GABA in postmortem tissue and have described potentially significant changes that accompany the illness. We have the opportunity of using high strength magnets to separate glutamate, glutamine, and GABA and analyze their concentrations regionally, spectroscopically using MRS in the living human person. This study will measure these and other molecules in medicated and unmedicated subjects with schizophrenia and normal volunteers. In addition, we will use fMRI to compare the neurochemical distributions of regional cerebral blood flow activations. Our hypothesis is that glutamatergic afferents to the ACC from the hippocampal cortex are hypoactive, resulting in reduced excitation in the ACC and also in other areas of the frontal cortex. This hypothesis can now be directly tested using a high strength magnet and MRS.
Methodology: Subjects aged 25-45 years of age, who have schizophrenia, will be recruited. Matched controls will also be recruited. Patients will receive structured clinical interviews to confirm diagnosis. Symptoms will be assessed using the PANSS. Patients will not be taken off of their medication for this study. Subjects will be scanned in a 4Tesla MRI machine for both spectroscopy and fMRI. For fMRI, subjects will be scanned undergoing two tasks (decision and sensory motor control) and in a resting phase.
Exposure to Ionizing Radiation, Radioactive Substances, and Chemical Substances:
Does not apply
Involvement of Human Subjects:
Procedures involving Human Subjects: Procedures are described above
Risks: The risks are minimal as no procedures are invasive. Subjects may become bored or fatigued during some of the tasks. Breaks will be given to help prevent this. All subjects will provide written, informed consent prior to study participation. Subjects are free to withdraw from the study at any time without consequence.
"Genomics and white matter abnormalities in schizophrenia."
Principal Investigator: Dr. Kelvin O. Lim, MIND Institute
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: UMN
Most recent approval: 11/14/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 21
Reporting period for number of human subjects:
Other: 01/01/02 to 12/31/02
Explanation:
MIND Institute fiscal year
Type(s) of Human Subjects Involvement:
Objectives: The recent availability of gene chip arrays has allowed the efficient examination of gene expression in complex disorders. Postmortem gene expression studies in schizophrenia have recently reported the reduced expression of sets of genes related to myelination. In vivo neuroimaging studies have revealed potential white matter metabolic and microstructural abnormalities in schizophrenia. The overall aim of this proposal is to perform a pilot antimortem study examining the relationship between white matter abnormalities, detected by recently developed in vivo MR measures, and selected white matter related candidate genes, identified through completed and ongoing gene expression and other genomic studies. This pilot proposal would be the first to combine in vivo neuroimaging measures with genomics information. The information would be complementary to that obtained through postmortem studies and provide a logical extension of postmortem studies.
Methodology: The investigators plan to study 40 patients with schizophrenia and 48 healthy controls. All subjects will be between 18-50 years of age. All subjects will be scanned and blood samples collected.
Exposure to Ionizing Radiation, Radioactive Substances, and Chemical Substances:
Not applicable
Involvement of Human Subjects:
Procedures involving Human Subjects: see above
Risks: The risks are minimal. Blood draws can result in bruising at the site where it was drawn. The Scan is non-invasive an presents minimal risk. Subjects may become bored or fatigued during some of the tasks. Breaks will be given to help prevent this. All subjects will provide written, informed consent prior to study participation. Subjects are free to withdraw from the study at any time without consequence.
Privacy/Confidentiality/Consent: All information will be kept confidential. The FDA and study sponsor may access study records. In publications resulting from this study, no names will be used.
"The neural network of auditory verbal hallucinations"
Principal Investigator: Dr. Massoud Stephane, MIND Institute
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: UMN VAMC
Most recent approval: 11/19/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 21
Reporting period for number of human subjects:
Other: 01/01/02 to 12/31/02
Explanation:
MIND Institute fiscal year
Type(s) of Human Subjects Involvement:
Objectives: Research focusing on individual psychotic symptoms avoids the diagnostic ambiguity of schizophrenia. Auditory verbal hallucinations (AVH) affect up to 70% of schizophrenic patients. AVH research could clarify important aspects of the pathophysiology of schizophrenia. However, this research faces a set of challenges they include:
1) Unpredictability of the occurrence of AVH: this makes direct study a rare opportunity. An abnormal experience is likely to be related to a dysfunction of brain mechanisms underlying normal functions. As AVH arise from a speech disorder, efforts should be made to study language processing in hallucinating patients. Language is linked to a set of distinct, non-overlapping, but interconnected processors. They subserve sublexical, lexical, syntactic and discourse components and work in concert with other cognitive resources such as attention and working memory. Characterizing language processing in hallucinating patients would shed light on AVH neural mechanisms.
2) Phenomenological variations of AVH: all AVH meet the basic definition---perception of speech in the auditory modality without corresponding external stimuli. However, they vary among multiple phenomenological dimensions, such as repetitive or systematized content, and linguistic complexity (hearing words, sentences or conversations). There is evidence that the phenomenological variations correspond to variability in the underlying pathophysiology. For example, AVH with repetitive content respond to treatment with antiobsessional agents. A number of PET studies show the activating profile of verbal stimulations varies with the linguistic complexity of the stimuli. Therefore it is necessary to subgroup AVH according to the phenomenological variables in order to clarify neural substrates.
3) AVH, like most brain dysfunctions and functions, are related to a serial and parallel distributed neural network. Therefore, temporospatial imaging such as MEG is particularly suitable method for AVH research. As antipsychotics alter the magnetic signal, studying drug free and naive patients is advantageous.
We hypothesize that AVH result from the dysfunction of a serial and parallel distributed neural network, which includes language neural mechanisms. The phonomenological variation of AVH and the associated patterns of cognitive and linguistic deficits are related to pathologies at different locations along this network. The aims are: characterization of cognitive and language processing deficits associated with each phenomenological variable; and characterization of the parallel and serial neural network associated with AVH by MEG.
Methodology: 30 drug free or naive patients with a history of AVH and 30 controls will undergo assessment of symptoms and neuropsychological testing. Subjects will then be imaged in resting states and during hallucinations (patients).
Exposure to Ionizing Radiation, Radioactive Substances, and Chemical Substances:
Not applicable
Involvement of Human Subjects:
Procedures involving Human Subjects: see above
Risks: The risks are minimal as no procedures are invasive. Subjects may become bored or fatigued during some of the tasks. Breaks will be given to help prevent this. All subjects will provide written, informed consent prior to study participation. Subjects are free to withdraw from the study at any time without consequence.
"fMRI studies of single-noun processing in schizophrenia"
Principal Investigator: Dr. Jose Pardo, MIND Institute
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: UMN
Most recent approval: 07/21/02
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: 01/01/02 to 12/31/02
Explanation:
MIND Institute fiscal year
Type(s) of Human Subjects Involvement:
Objectives: It has recently been discovered that when schizophrenia patients look at words (simple, common, concrete nouns) or read them aloud, brain activation spreads abnormally to other language areas that healthy control subjects do not recruit based on the instructions for the task. This spread occurs despite the preserved ability to read aloud. The phenomenon call been termed "spreading neuronal activation" by the investigators. This proposal aims to answer three questions about this abnormality: 1) does spreading neuronal activation reflect the degree of thought disorder in patients (and will medications alter this pattern?), 2) is spreading neuronal activation caused by dysfunction in automatic or attentional processing? 3) What cognitive operations do schizophrenic patients employ to result in such patterns of brain activity (an can healthy subjects also produce such patterns given the right task instructions)? To answer these questions, the investigators will apply fMRI to measure brain activation as patients and controls process single nouns under varying instructions (context).
The anticipated outcome of this research is greater understanding of spreading neuronal activation, a process likely to account for disturbances of language and thought so common in schizophrenia. In addition, data from ongoing studies using MEG to study word processing in schizophrenia have the potential to combine synergistically with these fMRI data using multimodal techniques to visualize both spatial and temporal components of spreading neuronal activation in patients. Such information is pivotal toward understanding the disease mechanisms, which history has proven is essential to design rationally new and effective treatments.
Methodology: 15 patients and 15 controls will be recruited. All subjects will be right handed, and controls will be matched for age, gender and IQ. Subjects will undergo fMRI scanning while completing the noun task.
Exposure to Ionizing Radiation, Radioactive Substances, and Chemical Substances:
Not applicable
Involvement of Human Subjects:
Procedures involving Human Subjects: See above
Risks: The risks are minimal as no procedures are invasive. Subjects may become bored or fatigued during some of the tasks. Breaks will be given to help prevent this. All subjects will provide written, informed consent prior to study participation. Subjects are free to withdraw from the study at any time without consequence.
Privacy/Confidentiality/Consent: All information will be confidential. The FDA and study sponsor may access study records. Publications resulting from this study will not mention names.
"MEG of visual attention deficits in schizophrenia"
Principal Investigator: Dr. Scott R. Sponheim, MIND Institute
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: UMN
Most recent approval: 03/27/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 20
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
Objectives: A vast body of evidence indicates that schizophrenia is a brain disorder. Despite powerful techniques for studying the brain, researchers have made limited progress in detailing the expression of schizophrenia in the central nervous system. Perhaps the largest obstacle to uncovering central nervous system etiology in schizophrenia is the limited scientific utility of the disorder's symptom-based definition. Scientists are calling for different ways to define this disorder. Ideally, characterization of schizophrenia would be reliable and simple, near the level of brain structure or function, be stable within individuals over time, and provide a more powerful examination of the disorder's genetic and environmental underpinnings. The marriage of an ongoing family study with a powerful techniques for describing brain function (MEG) presents an opportunity to identify functional brain abnormalities evident in schizophrenia that are associated with genetic liability for the disorder. Impaired visual attention is one of the consistently documented cognitive deficits in schizophrenia. Vigilance deficits are relatively stable over disorder course, and vigilance, serial search and backward masking deficits are present in schizophrenia patients, people at genetic risk for schizophrenia and those in remission for the disorder. Therefore, impaired visual attention is a potentially useful phenotype in examining the etiology of schizophrenia. Although many studies provide behavioral descriptions of impaired visual attention in schizophrenia, little is known about the brain mechanisms underlying the dysfunction. Recent investigations have revealed high frequency oscillations in the visual cortex that may bind information from neurons at both short and long distances in the brain. Recent studies point to the synchrony of gamma oscillations as important to cognitive processing. Gamma activity provides information unique from evoked potentials and possesses the necessary temporal resolution for scientists to test biological models of visual attention deficits in schizophrenia.
Methodology: 5 patients, 5 of their biological siblings and 5 non-psychiatric control subjects will complete the MEG protocol. The MEG subjects will be selected based upon their EEG readings. Research staff will administer symptom assessments (SANS, SAPS and BPRS) and controls will receive the SIS, SPQ and SCID-II. While MEG is being conducted subjects will undergo visual attention tasks.
Exposure to Ionizing Radiation, Radioactive Substances, and Chemical Substances:
Not applicable
Involvement of Human Subjects:
Procedures involving Human Subjects: See above
Risks: The risks of MEG are minimal as it is non-invasive. Subjects will be given breaks to prevent fatigue. Subjects will provide written, informed consent. Participation id voluntary and subjects may withdraw at any time without consequence.
Privacy/Confidentiality/Consent: All information collected is confidential. The FDA and study sponsor may access study records. In publications resulting from this study, no names will be used.
"fMRI Study of Spatial Memory in Adolescents with Schizophrenia"
Principal Investigator: Dr. Tonya White, MIND Institute
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: MIND Institute
Most recent approval: 06/13/02
IRB approval number: 0205M25581
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 9
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
Objectives: Current theories of schizophrenia explain the considerable heterogeneity in cognitive and clinical symptoms as a result of aberrations in brain connectivity. Studies using structural MRI, PET and functional MRI have demonstrated a number of regions implicated as nodes within the circuitry, including the dorsolateral prefrontal cortex, basal ganglia, thalamus, and the cerebellum. Spatial working memory taps into many of these brain regions and has been found to be impaired in schizophrenia. Furthermore, the underlying neuronal circuitry of spatial working memory has also been fairly well defined in both human and infrahuman studies. This provides an opportunity to assess connectivity of brain regions using high field MR, optimizing both spatial and temporal resolution. The purpose of this study is to evaluate the functional connectivity in adolescents with schizophrenia on a task of spatial working memory compared to a group of gender matched siblings, and healthy controls. A time-locked event related paradigm will be utilized to optimize temporal resolution.
Methodology: three groups of right-handed adolescents between 12 and 17 will be recruited to participate in the study. The first group will have been diagnosed with either schizophrenia, schizoaffective disorder or schizophreniform disorder. Patients who are either neuroleptic naive or undergoing a medication wash will be approached for participation in this study. The second group will be same-sex siblings who are closest in age to the patients who do not have a psychotic disorder. The third group will consist of healthy controls without evidence of a medical or psychiatric disorder. Two tasks to assess spatial working memory will be utilized. Participants will first be tested outside of the scanner to collect data and to assure that they have learned the task prior to being in the scanner (to reduce variability in performance).
Exposure to Ionizing Radiation, Radioactive Substances, and Chemical Substances: Not applicable
Involvement of Human Subjects:
Procedures involving Human Subjects: See above
Risks: There are minimal risks as these procedures are noninvasive. Participants might become bored or fatigued. Subjects will be given breaks to avoid fatigue.
Privacy/Confidentiality/Consent: Subjects must give informed consent prior to any study procedures. All information will be confidential. The FDA and study sponsor may access study records. Subjects are free to withdraw at any time without consequence.
"Dynamic study of rapid semantic priming in schizophrenia"
Principal Investigator: Dr. Patricia J. Pardo, MIND Institute
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: UMN VAMC
Most recent approval: 04/02/02
IRB approval number: VAMC 2778
Explanation of IRB approval:
Aproval for 1/1/02-12/31/02
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: 01/01/02 to 12/31/02
Explanation:
MIND Institute fiscal year
Type(s) of Human Subjects Involvement:
Objectives: Schizophrenia patients exhibit difficulties in cognitive processing, directly hindering everyday functioning and quality of life. Cognitive behavioral studies have identified aberrant semantic and lexical processing in schizophrenia patients as compared to control subjects. Some of these difficulties have been correlated to the presence of thought disorder (TD). Several studies in semantic priming (facilitation of meaningfully related concepts) in TD schizophrenia patients suggest a dysfunctional organization of semantic memory or retrieval specific in these patients. Other studies have not replicated these findings. Small differences in cognitive task paradigms can yield very different results in both patient and normal control studies, highlighting the need to implement additional tools to discover the dynamic cognitive architecture of both normal and schizophrenic linguistic processing. Whole-head magnetoencephalography (MEG) provides a unique opportunity for dissecting the temporal course and coherence of dynamic cortical responses. The investigators propose to use MEG to identify the time course, magnitude, and coherence of online changes in neuromagnetic flux elicited by rapid, facilitative semantic priming. The specific aims are:
1) To test the hypothesis that the magnetically recorded neuronal responses to target word trials will elicit substantially different dynamic patterns of cortical response following primed target words in TD schizophrenia patients as compared to non-TD schizophrenia patients and control subjects; and 2) to characterize the relationships between components of TD, priming, and neuromagnetic evoked responses.
Observing semantic processing in schizophrenia, via directly measuring neuromagnetic responses, should provide unique and meaningful contributions to the field of schizophrenia. Also, findings from this project will lay the groundwork essential for future grant applications to continue this effort.
Methodology: Fourteen adult schizophrenia patients (7 with TD and 7 with minimal TD) as measured by the scale for the assessment of thought, language and communication, and six matched control subjects will be recruited. Subjects will all be right-handed, aged 18-65 with English as their primary language. Special effort will be made to study unmedicated patients. Subjects will undergo whole-head anatomical MRI scanning. These images will be co-registered with MEG data to facilitate realistic-head modeling. These tests will be conducted while subjects are performing viaul word tasks.
Exposure to Ionizing Radiation, Radioactive Substances, and Chemical Substances:
Not applicable
Involvement of Human Subjects
Procedures involving Human Subjects: see above
Risks: The risks are minimal as procedures are non-invasive, subjects will be given breaks
Privacy/Confidentiality/Consent: Subjects will be consented prior to any study participation. All information will be kept confidential. The FDA and study sponsor may access study records. In publications resulting from this study no names will be used.
"Ultru high field fMRI and MEG for praxis"
Principal Investigator: Dr. Apostolos P. Georgopoulos, MIND Institute
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: UMN VAMC
Most recent approval: 06/14/01
IRB approval number: 0006M55401
Explanation of IRB approval:
Approved on 6/14/01 for the year of 1/1/02-12/31/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 8
Reporting period for number of human subjects:
Other: 01/01/02 to 12/31/02
Explanation:
MIND Institute fiscal year
Type(s) of Human Subjects Involvement:
Objectives: The long-term goal of this research is to elucidate the function of the posterior parietal cortex in maze solving and route following, which are typical praxis tasks. For that purpose, the investigators will study the same subjects during performance of the same tasks using (a) single-trial, time-resolved, very high spatial resolution functional magnetic resonance imaging (fMRI) at ultra high magnetic fields (7Tesla) and (b) single-trial, very high temporal resolution 248-sensor magnetoencephalography (MEG). The investigators will focus on the spatial representation and dynamic organization of the parietal cortex with respect to visuaospatial functions for which it is essential. It is the understanding of the investigators that this will be the first time that a brain area will be investigated in such a spatio-temporal detail and in a single-trial design.
Methodology: Study subjects will be 10 healthy, right-handed persons (5 male. 5 female) between the ages of 20-55 with no known disease of the nervous system. All subjects will have an IQ >85. Subjects will undergo the same maze task during both fMRI and MEG testing. This task will involve using a joystick to navigate a maze.
Exposure to Ionizing Radiation, Radioactive Substances, and Chemical Substances:
Not applicable
Involvement of Human Subjects:
Procedures involving Human Subjects: Procedures are listed above. All subjects will give informed consent prior to study participation. The study is voluntary and subjects may withdraw at any time without consequence.
Risks: Risks are minimal as procedures are non-invasive. Subjects will be given breaks to prevent fatigue.
Privacy/Confidentiality/Consent: All information will be kept confidential. The FDA and study sponsor may access study records. In publications resulting from this study names will not be mentioned.
"Initial Efficacy Study of a New Whole-Head Magnetoencephalograpy System"
Principal Investigator: Dr. Roland Lee, MIND Institute
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: NMVA
Most recent approval: 03/04/02
IRB approval number: HRRC 02-076
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: 01/01/02 to 12/31/02
Explanation:
MIND Institute fiscal year
Type(s) of Human Subjects Involvement:
Objectives: The purpose of this study is to test a new system design for performing completely noninvasive functional neuroimaging using magnetoencephalography (MEG). The study is designed to evaluate the effectiveness of this new system.
Methodology: Subjects undergo MEG and MRI while they perform various auditory and visual tasks.
Exposure to Ionizing radiation, Radioactive Substances, and Chemical Substances:
No ionizing radiation, radioactive substances, or chemical substances are used.
Involvement of Human Subjects:
Subjects are asked to perform various auditory and visual tasks such as watch small pictures, listen to some sounds, or feel puffs of air. Patients are required to wear electrodes that may be uncomfortable. They also obtain an MRI that requires lying in the MRI machine that some subjects may find uncomfortable. The testing may take up to 2 hours, which may be uncomfortable. There are no known risks associated with MEG or MRI. Data are maintained under lock and are not disseminated other than to collaborators or to appropriate government agencies.
"Longitudinal assessment brain neurochemistry early in schizophrenia with high-field proton spectroscopy as a predictor of functional deterioration."
Principal Investigator: Dr. Juan Bustillo, MIND Institute
Project started in: 2002
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: HRRC 02-051
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: UNM
Most recent approval: 03/14/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 34
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
Objectives: The purpose of the study is to evaluate whether various brain chemicals in persons with schizophrenia change after the person begins treatment with antipsychotic medications.
Methodology: A special brain study called Magnetic Resonance Spectroscopy (MRS) will be used in this study. The antipsychotic medications that may be used in this study include quetiapine, risperidone, haloperidol and clozapine, all of which have been repeatedly proven to treat the symptoms of schizophrenia. In addition to the MRS, subjects will also receive cognitive assessments.
Exposure to Ionizing radiation, Radioactive Substances, and Chemical Substances:
Not Applicable
Involvement of Human Subjects:
Procedures involving Human Subjects: After obtaining informed consent in writing, subjects will be given a physical exam, have their medical chart reviewed and will be interviewed about their physical and mental health and other general questions about their life. Blood and urine samples will be collected for laboratory tests. Subjects will need to fast for at least eight hours prior to having their blood drawn. Following the initial procedures, subjects will have an MRS exam. This will take approximately one hour and fifteen minutes. Subjects will also do cognitive assessments. Some will be computer-administered tests and others administered by a person. There will be numerous breaks to prevent fatigue. Subjects will start with one medication (quetiapine) and see their study doctor weekly for 1 month, then every other week for 1 month then monthly thereafter. If symptoms do not improve after 2 months, the study doctor may recommend changing to a different medication. The study includes a pre-defined sequence of medications.
The MRS exam will be repeated at 1 month, 6 months and at the end of the study (1 year). The cognitive assessments and blood labs will be repeated at 6 months and 1 year. Subjects may withdraw from the study at any time without consequence.
Risks: MRS exams are very safe but can be difficult for persons with claustrophobia. The test will immediately stop if a subject experiences discomfort. If they choose to continue, a mild sedative may be available to help them remain comfortable in the MRS machine.
Numerous breaks will be given to prevent fatigue. It is possible that the medication may not work or that a subject's symptoms may worsen. The study doctor will discuss the risks and side effects of each of the medications with each subject.
Privacy/Confidentiality/Consent: Information obtained in this study will be handled as confidentially as possible. Representatives from the MIND Institute, the Food and Drug Administration and the University of New Mexico Research Review Committee may be permitted access to records. No names will be used in any published reports.
"Brain Morphology and neurochemistry in child and adolescent onset schizophrenia"
Principal Investigator: Dr. Rhoshel Lenroot, MIND Institute
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: UNM
Most recent approval: 09/12/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 6
Reporting period for number of human subjects:
Other: 01/01/02 to 12/31/02
Explanation:
MIND Institute fiscal year
Type(s) of Human Subjects Involvement:
Objectives: The preliminary aim of this study is to determine if abnormalities in cerebral development in young people with childhood and adolescent onset schizophrenia-spectrum disorders are detectable in measures of brain surface morphology. Changes in brain surface morphology associated with loss of cortical tissue can be described as cortical peaks becoming sharper (higher absolute value of gyral curvature) and sulcal valleys becoming more broad and flat (lower absolute value of sulcal curvature). The investigators hypothesize that in children and adolescents with schizophrenia: 1) measures of average gyral curvature will be found to be higher in patients than in controls; 2) measures of average sulcal curvature will be found to be lower in patients than in controls; and 3) average cortical thickness will be decreased in patients, compared to controls. A secondary aim will be to acquire pilot data and to explore whether absolute concentrations of N-acetylaspartate (NAA), a biochemical "marker" of neuronal viability, is decreased in this population compared with normal controls.
Methodology: Participants will begin with an interview lasting about 2 hours. This interview will cover current symptoms and personal/family history. Subjects will then have an MRI scan.
Exposure to Ionizing radiation, Radioactive Substances, and Chemical Substances: not applicable
Involvement of Human Subjects:
Procedures involving Human Subjects: Procedures are described above
Risks: The risks are minimal as there are no invasive procedures. Subjects will be given breaks to prevent fatigue.
Privacy/Confidentiality/Consent: All subjects must provide informed written consent prior to participation. Subjects may withdraw at any time without consequence. All information in this study will be kept confidential. The FDA and sponsor of this study may access records. In publications resulting from this study, no names will be used.
"Sensory gating and working memory in schizophrenia"
Principal Investigator: Dr. Jose Canive, MIND Institute
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: UNM
Most recent approval: 11/29/01
IRB approval number: HRRC-99-336
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 68
Reporting period for number of human subjects:
Other: 01/01/02 to 12/31/02
Explanation:
MIND Institute fiscal year
Type(s) of Human Subjects Involvement:
Objectives: Problems with attention and perception are often noted to be core features of schizophrenia and have been hypothesized to result in deficits in the filtering or gating of sensory input. This research is to utilize magnetoencephalography (MEG) and electroencephalography (EEG) to study how sounds and touch are processed in individuals with schizophrenia as compared to individuals who do not have schizophrenia. So that brain activity can be related to the anatomy of the brain, subjects will also have an MRI of their brain.
Methodology: Use of MEG, EEG and MRI. Patients with schizophrenia will be assessed with symptom rating scales (SANS, PANSS, Calgary Depression Inventory and Brief Psychiatric Rating Scale). Other measures such as The Barnes Akathesia Scale, Abnormal Involuntary Movement Scale and the Simpson-Angus Scale will also be administered. All subjects will be given a battery of neuropsychological tests including Welscher scales, continuous performance tests, and scales to measure attention, planning and working memory.
Exposure to Ionizing radiation, Radioactive Substances, and Chemical Substances:
Not Applicable
Involvement of Human Subjects:
Procedures involving Human Subjects: For EEG testing electrodes will be placed at various locations on the head. The adhesive used will easily wash out of hair. For MEG testing, a sensor device known as a neuromagnetometer will be placed over the head to measure the magnetic fields produced by the brain. Each test will take approximately 20-30 minutes. The entire battery of tests could take as long as 6 hours. They may be spread out over two days, if needed. Subjects will be given numerous breaks. Subjects will not be required to stop taking any medications for this study.
Risks: The only risk involved is potential fatigue or frustration fro the tests. Subjects will be given numerous breaks. Subjects may withdraw from the study at any time without consequence.
Privacy/Confidentiality/Consent: Information will be handled as confidentially as possible. The University of New Mexico Institutional Review Board and the Food and Drug administration will be permitted to access records, as well as the MIND Institute. In any reports or publications, subject names will not be used. Informed Consent will be obtained in writing.
"Functional MRS of the normal brain."
Principal Investigator: Dr. William Brooks, MIND Institute
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: UNM
Most recent approval: 06/25/02
IRB approval number: 02-075
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 20
Reporting period for number of human subjects:
Other: 01/01/02 to 12/31/02
Explanation:
MIND Institute fiscal year
Type(s) of Human Subjects Involvement:
Objectives: The purpose of this study is to gain a better understanding of how and when normal brains process different kinds of information. Through the use of Magnetic Resonance Imaging (MRI) and cognitive testing, the researchers are interested in determining the relationships between certain chemicals in the brain and behavioral functions, such as decision-making and emotional processes. They also seek to understand how individual differences in development affect brain chemicals and the way information is processed. An understanding of the normal brain will enable researchers to pinpoint what is potentially going wrong with a diseased brain, possibly leading to new diagnostic and treatment methods.
Methodology: Subjects who meet eligibility criteria will have measurements taken of specific body parts (i.e. head circumference, distance between eyes.). Palm prints will also be taken. Subjects will also be given a battery of cognitive tests. This will take approximately 2-3 hours. Subjects will also receive MRI and Magnetic Resonance Spectroscopic Imaging (MRSI). A radiologist will read all MRIs and subjects will be notified of abnormalities.
Exposure to Ionizing radiation, Radioactive Substances, and Chemical Substances:
Not Applicable
Involvement of Human Subjects:
Procedures involving Human Subjects: see Methodology
Risks: While there are no risks from any of the procedures, subjects may become fatigued or bored during cognitive testing or the MRI testing. Subjects who are claustrophobic may experience some discomfort while in the MRI machine. Persons who have a pacemaker, or any metal in their body, such as an aneurysm clip, ear implant or nerve stimulator will not be eligible to participate. Subjects will be given breaks. Subjects are free to withdraw at any time without consequence.
Privacy/Confidentiality/Consent: All information will be handled as confidentially as possible. The University of New Mexico Research Review Committee and the Food and Drug Administration will have access to study records. No names will be used in published reports.
"Dynamic Systems Mediating Verbal and Spatial Working Memory Tasks as Characterized by MEG"
Principal Investigator: Dr. Cheryl J. Aine, MIND Institute
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: University of New Mexico
Most recent approval: 02/07/02
IRB approval number: 01-537
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 8
Reporting period for number of human subjects:
Other: 01/01/02 to 12/31/02
Explanation:
Project runs for calendar year
Type(s) of Human Subjects Involvement:
Objectives: The motivation for this study is the hypothesis that schizophrenia is a consequence of a functional disruption in connectivity and communication in neuronal circuits that effect rapid online monitoring and coordination of mental activity. Specific aims include: the development of two working memory tasks that can be used effectively with non-invasive magnetoencephalography (MEG) for characterization of the spacio-temporal aspects of neuronal population dynamics in the thalamus, cerebellum and cortical brain regions in schizophrenic patients and normal controls. To modify existing Multi-Start Spatio-Temporal (MSST) algorithms used for MEG data analysis in order to facilitate investigations of the cerebella, thalmic, and pre-frontal brain activity during the performance of these working memory tasks.
Methodology: Ten normal subjects will be recruited from University of New Mexico (5 male, 5 female) in order to pilot the two working memory studies. IN addition to having the MEG test, subjects will perform the Delayed Spatial Working Memory Task and the Modified Sternberg Task.
Exposure to Ionizing radiation, Radioactive Substances, and Chemical Substances: Not applicable
Involvement of Human Subjects:
Procedures involving Human Subjects: 10 normal subjects will be recruited for MEG and neuropsychological testing. All subjects will give informed consent and are free to withdraw at any time without consequence.
Risks: subjects might become bored or fatigued with the cognitive testing. Subjects will be given breaks as needed.
Privacy/Confidentiality/Consent: All information will be kept as confidential as possible to the extent allowed by law. The FDA and the sponsor may access the records from this study. In any publications, no names will be used.
"MEG Studies of Temporal Information Processing in Normal Subjects"
Principal Investigator: Dr. Claudia Tesche, MIND Institute
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: The University of New Mexico
Most recent approval: 12/10/01
IRB approval number: HRRC 20-287
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 41
Reporting period for number of human subjects:
Other: 01/01/02 to 12/31/02
Explanation:
MIND Institute fiscal year
Type(s) of Human Subjects Involvement:
Objectives: The objective of this study is to develop a better understanding of how the brain processes sensory information.
Methodology: Patients perform various auditory and visual tasks. Wavelet and FFT power spectral densities are computed for all source waveforms. A Cross-covariance analysis is performed on the time courses of the source waveforms.
Exposure to Ionizing radiation, Radioactive Substances, and Chemical Substances: Subjects are not exposed to any radiation, radioactive substances, or chemical substances during this study.
Involvement of Human Subjects: Patients undergo training for various auditory and visual tasks. Following the training, they undergo a combined EEG and MEG analysis of brain activity while performing these tasks. Patients have EEG electrodes pasted to their head, which may be uncomfortable. There is no known risk involved in recording MEG or EEG activity from these electrodes and sensors. Records are kept in a locked cabinet and are not disseminated other than to collaborators or to appropriate government agencies.