Ms. Melissa
Hilleary
1101 Yale Blvd., NE
Albuquerque, NM 87131
Phone: 505-272-2083
Fax: 505-272-8002
E-mail: mhilleary@themindinstitute.org
Number of Human Subjects projects reported: 35
| MIND-02-0108M06981 | "Ultra-high Field fMRI and MEG for Praxis" |
| MIND-02-MGH2002-P-00580/1 | "Multimodality Imaging of Cognitive Processes in Normal Subjects " |
| MIND-02-MGHMcCarley | "Temporal Lobe Neocortical Abnormalities in Schizophrenia: A Structural, Functional and Clinical Perspective " |
| 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 02-267 | "Dynamic Systems Mediating Verbal and Spatial Working Memory Tasks as Characterized by MEG" |
| MIND-04-510H-N1 | "MIND Clinical Imaging Consortium" |
| MIND-04-533-N1 | "National Consortium Project" |
| MIND-04-540-N2 | "Schizophrenia Consortium" |
| MIND-04-561-N1 | "MIND Clinical Imaging Consortium Protocol: A Joint Study of First Episode and Chronic Schizophrenia" |
| MIND-04-MA-02 | "Spatiotemporal Dynamics of Context Processing in Schizophrenia" |
| MIND-04-MA-03 | "Use of Linguistic and Non-Linguistic Context in Language Comprehension in Schizophrenia" |
| MIND-04-MA-04 | "Toward the Prevention of Schizophrenia: Neurobiological Studies of Families with Schizophrenia" |
| MIND-04-MA-05 | "Auditory, Sensorimotor, and Language Area Mapping Using MEG With and Without fMRI Constraints" |
| MIND-04-MN-01 | "In-Vivo Measurement of Glutamatergic Neurotransmission" |
| MIND-04-MN-03 | "The Disregulation of Optimized Cognition in Schizophrenia" |
| MIND-04-MN-04 | "Investigating Brain Function, Connectivity and Neurochemistry in Health and Disease: High Field Magnetic Resonance Methodologies" |
| MIND-04-MN-05 | "MEG Studies of Schizophrenia" |
| MIND-04-MN-06 | "Clinical Research MEG Core" |
| MIND-04-NM-01 | "Magnetoencephalographic Studies of Information Processing in Normal Subjects" |
| MIND-05-540-N1 | "The MIND MEG Consortium - Human Calibration Study " |
| MIND-05-MA-02 | "Visual Responses to Local Stimuli" |
| MIND-05-MA-03 | "Multimodal Imagaing of Cognitive Processes: Contextual Predictions Facilitate Visual Cognition " |
| MIND-05-MN-01 | "Adolescent Psychosis Classification " |
| MIND-05-UNM-01 | "Brain Correlates of Cognitive and Personality Functioning in Human Volunteers" |
| MIND-05-UNM-04 | "Assessment of Lateralized Hippocampal Function in Schizophrenia" |
| MIND-05-UNM-05 | "Reliability of Proton Magnetic Resonance Spectroscopy Brain Measures " |
| MIND-06-300H-N1 | "Imaging the Development of Memory Strategies in Aging" |
| MIND-06-301-555 | "Assessment of Infant Brain Functions with Non-invasive Electrophysiological Techniques - Albuquerque" |
| MIND-06-301-556 | "Auditory and Visual Integration in Schizophrenia Examined Using MEG, EEG, and FMR" |
| MIND-06-420-550 | "Effect of Stimulus Rate and Selective Attention on the Blood Oxygen Level Dependent Response in Schizophrenia" |
| MIND-06-420-551 | "An Event-Related Study of Crossmodal Attention" |
| MIND-06-420-552 | "A Mulitmodal Study of Sensory Gating " |
| MIND-06-435-550 | "MRS Measures of Excitatory Neurotransmission in Pain and Fibromyalgia" |
| MIND-06-435-551 | "Activation of the Anterior Cingulate Due to Adverse Stimulus: An MR Study" |
| MIND-06-552H-N1 | "Glutamatergic Metabolism Across Disease Stages in Schizophrenia" |
"Ultra-high Field fMRI and MEG for Praxis"
Principal Investigator: Dr. Apostolos P. Georgopoulos, Minnesota Veterans Research Institute.
Project started in: 2002
This project ended in fiscal year 2006.
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: Minnesota Veterans Research Institute
Most recent approval: 08/24/04
IRB approval number: 0210M34182
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This project was conducted to combine data from functional magnetic resonance imaging (fMRI) at ultra high field strength (7 Tesla) and magnetoencephalography (MEG) in an attempt to utilize the high spatial resolution of the fMRI and the high temporal resolution of the MEG for a better understanding of brain function. Since data cannot be acquired simultaneously using both technologies, the Minnesota Partner Site has adopted the strategy to use the same subjects, performing the identical experiment in the two methods, and then attempt to bridge the gap. In preliminary experiments, eight subjects were studied and valid data obtained from three of the group. However, since such data acquisition was being performed for the first time at 7 Tesla, it was discovered that the radio frequency (RF) coils utilized were suboptimal for visualizing the cortex on the superior parietal lobule. Consequently, efforts in 2005 focused on developing multichannel array technology (coils and receivers) for this application.
"Multimodality Imaging of Cognitive Processes in Normal Subjects"
Principal Investigator: Dr. Caroline West, Massachusetts General Hospital
Project started in: 2002
This project ended in fiscal year 2006.
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: Massachusetts General Hospital
Most recent approval: 05/26/05
IRB approval number: 2002-P-00580
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This project conducted two experiments, one using functional magnetic resonance imaging (fMRI) and one using electroencephalography (EEG), applying an identical stimulus of a real-world event for both cases. The fMRI experiemnt was used to identify the precise location in the brain of the neural activity mediating comprehension of the videos. The EEG experiment revealed the millisecond by millisecond timecourse of the evoked activity. In addition, this effort was coordinated with Dr. Gina Kuperberg (see Project MIND-04-MA-03) to examine the deficits in comprehension of real world events in schizophrenia.
"Temporal Lobe Neocortical Abnormalities in Schizophrenia: A Structural, Functional and Clinical Perspective"
Principal Investigator: Dr. Robert W. McCarley, Massachusetts General Hospital
Project started in: 2002
This project ended in fiscal year 2006.
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: Massachusetts General Hospital
Most recent approval: 06/23/05
IRB approval number: M10543-108
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This project examined four separate hypotheses: (1) At first hospitalization of patients with schizophrenia, but not with manic psychosis, left-lateralized gray matter volume reduction would be found in the Middle Temporal Gyrus (MTG), as would bilateral reduction in Inferior Temporal Gyrus (ITG). These anatomical indicators point to the early presence of abnormalities found in chronic schizophrenia. (2) The second hypothesis anticipated that an enlarged longitudinal sample would show post-initial hospitalization progression of gray matter volume reduction in the left Superior Temporal Gyrus (STG) in schizophrenia, compared with manic psychosis, with most of the change occurring in the first six months following initial hospitalization. In contrast, the abnormalities in the MTG and ITG would not show progression, thus pointing out a pivotal role for the STG in schizophrenia diagnosis. In 2005, ten new subjects or restudy subjects were scanned by magnetic resonance imaging (MRI) for longitudinal sampling against hypotheses one and two. (3) The third hypothesis supposed that in chronic schizophrenia, compared with healthy controls, STG measurements over longer time periods (2.5 years) would show a progressive gray matter volume reduction, although at a lesser rate than in acute schizophrenia. In 2005, substantial completion of this study (begun in 2003) was accomplished with data for 30 subjects. (4) Finally, the fourth hypothesis looked at the evoked potential in schizophrenia associated with face processing. This premise theorized that the N170 would show a reduction proportional to the fusiform gyrus gray matter volume reduction and that gamma electroencephalography (EEG) processing abnormalities to steady state auditory gamma input would be associated with auditory hallucinations, indicating elementary circuit abnormalities in the schizophrenic auditory and para-auditory cortex. In 2005, substantial completion of N170 study was accomplished with data for approximately 30 subjects and substantial progress made on the gamma EEG portion of the effort with approximately 20 subjects. The study concluded on 12/31/05. No reportable human subjects activity from 10/01/05 to 09/30/06.
"Longitudinal assessment brain neurochemistry early in schizophrenia with high-field proton spectroscopy as a predictor of functional deterioration"
Principal Investigator: Dr. Juan Bustillo, University of New Mexico
Project started in: 2002
This project ended in fiscal year 2006.
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: 01/18/04
IRB approval number: 02-051
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
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.
Despite effective symptom reduction with antipsychotic medications, the majority of schizophrenia patients fail to achieve premorbid status and functional outcomes are generally poor. N-acetylaspartate (NAA), a marker of neuronal viability, is related to cognitive function and may predict functional outcome. NAA is reduced in prefrontal, thalamic, and mesial temporal brain regions in chronically-treated schizophrenia but may be normal early in the disease. The clinical significance and mechanisms accounting for this NAA reduction are poorly understood. A second line of evidence suggests that glutamine (Gln) may be elevated early in the illness. Glutamine concentrations primarily reflect glutamate (Glu) cleared from the synapse, providing an in-vivo index of glutamatergic neurotransmission. It has been postulated that in schizophrenia there is a progressive excitotoxic process involving hyperglutamatergia, which disrupts neuronal function and accounts for the global cognitive defects and poor psychosocial outcomes of the illness, despite the beneficial symptom reducing effects of antipsychotic medication.
Methodology: A special brain study technology called magnetic resonance spectroscopy (MRS) is used in this study. The antipsychotic medications that may be used in this study include quetipine, 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.
The project used high-field (4T) 1H-MRS to study NAA, Gln, and Glu in antipsychotic-naïve and minimally-treated schizophrenia. These neurometabolites will be measured in four regions where metabolic abnormalities have been previously reported: anterior cingulate, frontal white matter, medial thalamus, and hippocampus. 1H-MRS assessments will be repeated at 1, 6, and 12 months. Treatment with antipsychotic medications will be standardized and symptoms, side-effects, cognitive, and social function will be assessed prospectively. A group of healthy volunteers will also be followed longitudinally. This project will address three specific pressing issues: (1) the location and temporal evolution of brain NAA reductions during the first year of treatment in schizophrenia; (2) the relationship between NAA reductions and cognitive and social function outcomes; and (3) the relationship between abnormalities in glutamatergic metabolism and NAA reductions during the first year of treatment. Documentation that reductions of NAA are clinically relevant and are preceded and "driven" by hyperglutamatergia would, for example, support the early use of antiglutamatergic agents to prevent functional deterioration in schizophrenia.
"Dynamic Systems Mediating Verbal and Spatial Working Memory Tasks as Characterized by MEG"
Principal Investigator: Dr. Cheryl J. Aine, University of New Mexico
Project started in: 2002
This project ended in fiscal year 2006.
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: 05/31/05
IRB approval number: 02-267
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
Objectives: One hypothesis concerning the etiology of schizophrenia is that subtle neuropathological changes, such as cell loss or reduced neuropil, occur during development and later manifest in adolescence as a functional disruption in connectivity and communication in neuronal circuits involved in the coordination of mental activity. Most neuroimaging studies examining the neurophysiological basis of schizophrenia have demonstrated that working memory tasks, particularly spatial working memory tasks, are quite effective for revealing deficits in schizophrenic patients. Working memory processes appear to involve a large distributed network of cortical/subcortical areas.
The spatial and verbal working memory (WM) protocols focus on elucidating the brain dynamics associated with working memory and delayed recognition memory in schizophrenic brains and normal controls. Magnetoencephalography (MEG) combined with anatomical magnetic resonance imaging (MRI) are particularly useful for the temporal and spatial separation of sensory activity, encoding and delayed recognition memory, all within the same WM protocol. In addition, effective use of cross-correlation techniques (cross-correlations in source space) can help identify functional neural circuits involved in encoding and recognizing memory processes and the degree to which disparate brain regions respond together as a unit in schizophrenic brains compared to their normative control counterparts.
Method: Ten medicated schizophrenic patients and 10 age-matched controls will participate in two WM tasks (spatial and verbal) using the same physical stimuli. Single digits will be located within each cell of a 4x4 grid (16 cells total). All but one of the digits will be displayed in green color while the digit to be attended for future recognition will be displayed in red. A variant of the Sternberg task will be used where either memory set sizes of 1 or 3 will be used in order to examine the effect of memory load. The memory set items are presented sequentially in time. In the spatial task, subjects are instructed to encode the location of the red digit, while in the verbal task, subjects are instructed to encode the digit number itself. Neuromagnetic measurements will be made using a Neuromag 122-channel system at the Veterans Administration Medical Center. Automated analysis of the data will be accomplished by conducting limited searches through the pre-defined head volumes. Source locations will be displayed on the MRIs and their calculated timecourses will be evaluated statistically. It is predicted that schizophrenic patients will reveal a deficit in sustaining activity in the different brain regions involved in the task, which prevent a prefrontal-parietal circuit from communicating effectively between the constituent regions, thus having a negative impact on behavioral performance measures.
"MIND Clinical Imaging Consortium"
Principal Investigator: Dr. John Lauriello, University of New Mexico
Project started in: 2004
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 04-010
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: University of New Mexico
Most recent approval: 03/14/06
IRB approval number: 04-010
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 25
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This project conducts studies of two cohorts of schizophrenia patients, using the collective resources of four sites linked by The MIND Institute, including the University of New Mexico, University of Minnesota, Massachusetts General Hospital (Boston), and University of Iowa. Studies conducted at these sites are part of the MIND Clinical Imaging Consortium (MCIC), which is a multi-site longitudinal study using a common experimental protocol. The four projects involved in this effort are: MIND-04-510H-N1, MIND-04-533-N1, MIND-04-540-N2, and MIND-04-561-N1.
Over the long-term, this network has amassed a large database of information accessible from all participating sites. The database enables the integration and cross validation of clinical, cognitive, morphometric, and functional neuroimaging results gathered from unique samples of schizophrenia patients using a common experimental protocol across all of the sites. By facilitating the integration of data obtained from multiple sites, the exploration of relationships is enabled between variables that otherwise would otherwise obscure significant effects by adding to the variability and noise in the data. The primary clinical aims of this multi-site project are to identify the neural substrates of the core cognitive deficits associated with schizophrenia, their link to the clinical features of the disorder, and their alterations with disease progression and treatment. Major changes to the protocol in 2006 include introduction of electroencephalography/magnetoencephalography (EEG/MEG) imaging, with results compared and contrasted with magnetic resonance imaging (MRI).
Objectives:
1. Evaluate first episode (FE) patients (neuroleptic naïve, if possible) comprehensively at intake and follow them longitudinally with regular serial assessments of clinical and psychosocial measures at six month intervals.
2. Evaluate chronic, and chronically medicated, patients.
3. Make cross-sectional comparisons of FE verses chronic patients to identify initial crude indicators of the course and outcome of schizophrenia, while the longitudinal data accumulate.
Methodology:
1. Two groups of schizophrenia subjects, FE and chronic, will be comprehensively assessed using the following: clinical descriptors, sociodemographic descriptors, a comprehensive cognitive assessment, morphometric Magnetic Resonance Imaging (mMRI), functional Magnetic Resonance Imaging (fMRI), Diffusion Tensor Imaging (DTI), MEG, and collection of blood for genetic studies.
2. Healthy volunteers will be recruited. The comparison and schizophrenia groups will be matched in age, gender composition, handedness, and parental socioeconomic status.
Drugs/Devices/Pharmaceuticals:
Subjects will undergo MRI using a 1.5 Tesla research scanner and MEG.
Type of Human Subject Involvement:
Subjects in this protocol will be normal volunteers and schizophrenia patients. Men and women of all racial and ethnic backgrounds will be included. Volunteers will usually be adult students and/or employees of the University of New Mexico. Exclusion criteria will be: 1) pregnancy, 2) presence of a potentially dangerous device, implanted or otherwise, 3) age less than 18, 4) presence of a medical condition that makes MR scanning dangerous, 5) claustrophobia, 6) weight greater than 300 pounds, and 7) uncontrolled incontinence. Informed consent will be obtained from subjects according to institutional guidelines established by the individual site.
"National Consortium Project"
Principal Investigator: Dr. Charles Schultz, University of Minnesota
Project started in: 2004
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 0404M59124
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: University of Minnesota
Most recent approval: 04/05/06
IRB approval number: 0404M59124
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 8
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This project conducts studies of two cohorts of schizophrenia patients, using the collective resources of four sites linked by The MIND Institute, including the University of New Mexico, University of Minnesota, Massachusetts General Hospital (Boston), and University of Iowa. Studies conducted at these sites are part of the MIND Clinical Imaging Consortium (MCIC), which is a multi-site longitudinal study using a common experimental protocol. The four projects involved in this effort are: MIND-04-510H-N1, MIND-04-533-N1, MIND-04-540-N2, and MIND-04-561-N1.
Over the long-term, this network has amassed a large database of information accessible from all participating sites. The database enables the integration and cross validation of clinical, cognitive, morphometric, and functional neuroimaging results gathered from unique samples of schizophrenia patients using a common experimental protocol across all of the sites. By facilitating the integration of data obtained from multiple sites, the exploration of relationships is enabled between variables that otherwise would otherwise obscure significant effects by adding to the variability and noise in the data. The primary clinical aims of this multi-site project are to identify the neural substrates of the core cognitive deficits associated with schizophrenia, their link to the clinical features of the disorder, and their alterations with disease progression and treatment. Major changes to the protocol in 2006 include introduction of electroencephalography/magnetoencephalography (EEG/MEG) imaging (at the New Mexico site only), with results compared and contrasted with magnetic resonance imaging (MRI).
Objectives:
1. Evaluate first episode (FE) patients (neuroleptic naïve, if possible) comprehensively at intake and follow them longitudinally with regular serial assessments of clinical and psychosocial measures at six month intervals.
2. Evaluate chronic, and chronically medicated, patients.
3. Make cross-sectional comparisons of FE verses chronic patients to identify initial crude indicators of the course and outcome of schizophrenia, while the longitudinal data accumulate.
Methodology:
1. Two groups of schizophrenia subjects, FE and chronic, will be comprehensively assessed using the following: clinical descriptors, sociodemographic descriptors, a comprehensive cognitive assessment, morphometric Magnetic Resonance Imaging (mMRI), functional Magnetic Resonance Imaging (fMRI), Diffusion Tensor Imaging (DTI), MEG, and collection of blood for genetic studies.
2. Healthy volunteers will be recruited. The comparison and schizophrenia groups will be matched in age, gender composition, handedness, and parental socioeconomic status.
Drugs/Devices/Pharmaceuticals:
Subjects will undergo MRI using a 1.5 Tesla research scanner and MEG.
Type of Human Subject Involvement:
Subjects in this protocol will be normal volunteers and schizophrenia patients. Men and women of all racial and ethnic backgrounds will be included. Volunteers will usually be adult students and/or employees of the University of New Mexico. Exclusion criteria will be: 1) pregnancy, 2) presence of a potentially dangerous device, implanted or otherwise, 3) age less than 18, 4) presence of a medical condition that makes MR scanning dangerous, 5) claustrophobia, 6) weight greater than 300 pounds, and 7) uncontrolled incontinence. Informed consent will be obtained from subjects according to institutional guidelines established by the individual site.
"Schizophrenia Consortium"
Principal Investigator: Dr. Randy Gollub, Massachusetts General Hosptial
Project started in: 2004
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Massachusetts General Hospital
Most recent approval: 01/05/06
IRB approval number: 2004P-000524
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
MIND (Mental Illness and Neuroscience Discovery) Consortium Calibration Study
The purpose of this protocol is to calibrate the magnetic resonance scanners used in the MIND Clinical Imaging Consortium (MCIC). Massachusetts General Hospital (MGH) elected to keep this protocol active, although no subjects were processed through the study during the reporting period.
Specific Aims: The purpose of this initial calibration study is to develop and validate structural and functional magnetic resonance image (fMRI) acquisition and analysis methods to support a planned multi-site longitudinal neuroimaging study of schizophrenia. The clinical imaging study will be submitted as a separate IRB protocol.
1) To identify, measure, and minimize cross-site variability when performing cross-site functional and structural magnetic resonance imaging studies of healthy controls using the MIND consortium protocols.
2) To validate proposed cognitive activation paradigms, imaging acquisition methods, and data analysis strategies for a planned multi-site clinical imaging study in schizophrenic subjects.
Background: The goal of this proposal is to determine within-site and between-site reliability of the anatomical and functional MRI measures proposed by the MIND (Mental Illness and Neuroscience Discovery) Consortium. The MIND Consortium includes investigators at Massachusetts General Hospital, University of Minnesota, University of Iowa, and University of New Mexico. Studies conducted at these sites are part of the MIND Clinical Imaging Consortium (MCIC), which is a multi-site longitudinal study using a common experimental protocol. The four projects involved in this effort are: MIND-04-510H-N1, MIND-04-533-N1, MIND-04-540-N2, and MIND-04-561-N1.
The New Mexico site is coordinating the study. The initial step is to establish standardized functional magnetic resonance imaging acquisition protocols, experimental paradigms, and data analysis procedures using phantoms and healthy human subjects. This protocol is to obtain IRB approval to conduct the initial experimental calibration study in a cohort of ten human subjects who will travel to four acquisition sites and participate in scanning sessions to allow the collection of matching data sets. The resulting data will be analyzed to determine reliability and validity of patterns of activation during functional and structural magnetic resonance imaging across the participating sites.
Subjects will be exposed to:
FMRI: There are several sources of risks. For instance, the subject may experience discomfort being in the confined environment of the scanner. Or, the subject may experience discomfort and frustration carrying out the tasks. The MRI scan may indicate a medical problem in a subjects brain. If the study detects an abnormality in the MRI scan, this information may become part of the subjects hospital record. It is possible that a subject could be unnecessarily worried if a problem were suspected but not actually found.
Exposure to a high magnetic field. The primary known hazard associated with exposure to a static high magnetic field is that the magnet exerts a strong force on ferromagnetic objects. Conventional MRI uses 1.5 Tesla (T) magnets. At most research centers for functional MRI, the research systems for human use have field strengths of 3T or 4T. Imaging at these field strengths is not considered a significant risk according to Food and Drug Administration (FDA) guidelines.
Heating from radio frequency (RF) pulses. The RF pulses that are used for creating the MR signal deposit some energy in the body in the form of heat, but no ionizing radiation is used with MRI. Because the pulse sequences to be used are standard, FDA approved sequences, we do not expect any hazard associated with power deposition.
Peripheral nerve stimulation from rapidly switched magnetic fields (dB/dt). Magnetic field gradients are switched on and off during imaging to encode the spatial distribution of the MR signal. Gradient switching rate depends on the gradient coil used but does not depend on field strength. The FDA guideline states that a significant risk is involved only when "dB/dt sufficient to produce severe discomfort or painful stimulation" is used. Such severe discomfort has not been reported for studies performed at any of the participating institutions scanners using the standard pulse sequences to be employed in this study.
Acoustic noise. Acoustic noise is always an unwanted side effect of MR imaging. As currents are pulsed through the gradient coils within the magnetic field, the system acts like a loudspeaker, making a repetitive tapping sound.
Social risk: There is no social risk associated with participation in this study. There are no legal risks to the subjects associated with these paradigms.
There is a risk that the subjects confidentiality will not be maintained from sharing the data among multiple sites. It is possible to reconstruct a form of the facial features from the MRI data; this information may be considered individually identifiable data, though its ability to identify the person has not been confirmed.
There are no other known risks from participation in this study.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Massachusetts General Hospital
Most recent approval: 07/04/06
IRB approval number: 2004P-001360
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This project conducts studies of two cohorts of schizophrenia patients, using the collective resources of four sites linked by The MIND Institute, including the University of New Mexico, University of Minnesota, Massachusetts General Hospital (Boston), and University of Iowa. Studies conducted at these sites are part of the MIND Clinical Imaging Consortium (MCIC), which is a multi-site longitudinal study using a common experimental protocol. The four projects involved in this effort are: MIND-04-510H-N1, MIND-04-533-N1, MIND-04-540-N2, and MIND-04-561-N1.
Over the long-term, this network has amassed a large database of information accessible from all participating sites. The database enables the integration and cross validation of clinical, cognitive, morphometric, and functional neuroimaging results gathered from unique samples of schizophrenia patients using a common experimental protocol across all of the sites. By facilitating the integration of data obtained from multiple sites, the exploration of relationships is enabled between variables that otherwise would otherwise obscure significant effects by adding to the variability and noise in the data. The primary clinical aims of this multi-site project are to identify the neural substrates of the core cognitive deficits associated with schizophrenia, their link to the clinical features of the disorder, and their alterations with disease progression and treatment. Major changes to the protocol in 2006 include introduction of electroencephalography/magnetoencephalography (EEG/MEG) imaging (at the New Mexico site only), with results compared and contrasted with magnetic resonance imaging (MRI).
Objectives:
1. Evaluate first episode (FE) patients (neuroleptic naïve, if possible) comprehensively at intake and follow them longitudinally with regular serial assessments of clinical and psychosocial measures at six month intervals.
2. Evaluate chronic, and chronically medicated, patients.
3. Make cross-sectional comparisons of FE verses chronic patients to identify initial crude indicators of the course and outcome of schizophrenia, while the longitudinal data accumulate.
Methodology:
1. Two groups of schizophrenia subjects, FE and chronic, will be comprehensively assessed using the following: clinical descriptors, sociodemographic descriptors, a comprehensive cognitive assessment, morphometric Magnetic Resonance Imaging (mMRI), functional Magnetic Resonance Imaging (fMRI), Diffusion Tensor Imaging (DTI), MEG, and collection of blood for genetic studies.
2. Healthy volunteers will be recruited. The comparison and schizophrenia groups will be matched in age, gender composition, handedness, and parental socioeconomic status.
Drugs/Devices/Pharmaceuticals:
Subjects will undergo MRI using a 1.5 Tesla research scanner and MEG.
Type of Human Subject Involvement:
Subjects in this protocol will be normal volunteers and schizophrenia patients. Men and women of all racial and ethnic backgrounds will be included. Volunteers will usually be adult students and/or employees of the University of New Mexico. Exclusion criteria will be: 1) pregnancy, 2) presence of a potentially dangerous device, implanted or otherwise, 3) age less than 18, 4) presence of a medical condition that makes MR scanning dangerous, 5) claustrophobia, 6) weight greater than 300 pounds, and 7) uncontrolled incontinence. Informed consent will be obtained from subjects according to institutional guidelines established by the individual site.
"MIND Clinical Imaging Consortium Protocol: A Joint Study of First Episode and Chronic Schizophrenia"
Principal Investigator: Dr. Nancy C. Andreasen, University of Iowa
Project started in: 2004
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 3
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: University of Iowa
Most recent approval: 03/14/06
IRB approval number: 8103070
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This is a multi-site longitudinal study that collected clinical, cognitive, genetic, morphometic, and functional neuroimaging data from schizophrenia patients and matched controls using a common experimental protocol across four participating sites, including the University of New Mexico, University of Minnesota, Massachusetts General Hospital (Boston), and University of Iowa. Studies conducted at these sites are part of the MIND Clinical Imaging Consortium (MCIC). The four projects involved in this effort are: MIND-04-510H-N1, MIND-04-533-N1, MIND-04-540-N2, and MIND-04-561-N1. At the University of Iowa, the project was conducted under three separate IRB protocols: 8103070 was put into place to process first episode schizophrenia patients and their matched controls. First episode schizophrenia patients were of particular interest to the study in order to understand what factors were at play at the time of onset of the disease (typically, at the first psychotic break).
Over the long-term, this network has amassed a large database of information accessible from all participating sites. The database enables the integration and cross validation of clinical, cognitive, morphometric, and functional neuroimaging results gathered from unique samples of schizophrenia patients using a common experimental protocol across all of the sites. By facilitating the integration of data obtained from multiple sites, the exploration of relationships is enabled between variables that otherwise would otherwise obscure significant effects by adding to the variability and noise in the data. The primary clinical aims of this multi-site project are to identify the neural substrates of the core cognitive deficits associated with schizophrenia, their link to the clinical features of the disorder, and their alterations with disease progression and treatment. Major changes to the protocol in 2006 include introduction of electroencephalography/magnetoencephalography (EEG/MEG) imaging (at the New Mexico site only), with results compared and contrasted with magnetic resonance imaging (MRI).
Objectives:
1. Evaluate first episode (FE) patients (neuroleptic naïve, if possible) comprehensively at intake and follow them longitudinally with regular serial assessments of clinical and psychosocial measures at six month intervals.
2. Evaluate chronic, and chronically medicated, patients.
3. Make cross-sectional comparisons of FE verses chronic patients to identify initial crude indicators of the course and outcome of schizophrenia, while the longitudinal data accumulate.
Methodology:
1. Two groups of schizophrenia subjects, FE and chronic, will be comprehensively assessed using the following: clinical descriptors, sociodemographic descriptors, a comprehensive cognitive assessment, morphometric Magnetic Resonance Imaging (mMRI), functional Magnetic Resonance Imaging (fMRI), Diffusion Tensor Imaging (DTI), MEG, and collection of blood for genetic studies.
2. Healthy volunteers will be recruited. The comparison and schizophrenia groups will be matched in age, gender composition, handedness, and parental socioeconomic status.
Drugs/Devices/Pharmaceuticals:
Subjects will undergo MRI using a 1.5 Tesla research scanner and MEG.
Type of Human Subject Involvement:
Subjects in this protocol will be normal volunteers and schizophrenia patients. Men and women of all racial and ethnic backgrounds will be included. Volunteers will usually be adult students and/or employees of the University of New Mexico. Exclusion criteria will be: 1) pregnancy, 2) presence of a potentially dangerous device, implanted or otherwise, 3) age less than 18, 4) presence of a medical condition that makes MR scanning dangerous, 5) claustrophobia, 6) weight greater than 300 pounds, and 7) uncontrolled incontinence. Informed consent will be obtained from subjects according to institutional guidelines established by the individual site.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: University of Iowa
Most recent approval: 12/05/05
IRB approval number: 1998010017
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This is a multi-site longitudinal study that collected clinical, cognitive, genetic, morphometic, and functional neuroimaging data from schizophrenia patients and matched controls using a common experimental protocol across four participating sites, including the University of New Mexico, University of Minnesota, Massachusetts General Hospital (Boston), and University of Iowa. Studies conducted at these sites are part of the MIND Clinical Imaging Consortium (MCIC). The four projects involved in this effort are: MIND-04-510H-N1, MIND-04-533-N1, MIND-04-540-N2, and MIND-04-561-N1. At the University of Iowa, the project was conducted under three separate IRB protocols: 1998010017 was put into place to process chronic schizophrenia patients and their matched controls. Chronic schizophrenia patients were included in the study to provide data about the long-term course of the disease and its effect on brain anatomy and function.
Over the long-term, this network has amassed a large database of information accessible from all participating sites. The database enables the integration and cross validation of clinical, cognitive, morphometric, and functional neuroimaging results gathered from unique samples of schizophrenia patients using a common experimental protocol across all of the sites. By facilitating the integration of data obtained from multiple sites, the exploration of relationships is enabled between variables that otherwise would otherwise obscure significant effects by adding to the variability and noise in the data. The primary clinical aims of this multi-site project are to identify the neural substrates of the core cognitive deficits associated with schizophrenia, their link to the clinical features of the disorder, and their alterations with disease progression and treatment. Major changes to the protocol in 2006 include introduction of electroencephalography/magnetoencephalography (EEG/MEG) imaging (at the New Mexico site only), with results compared and contrasted with magnetic resonance imaging (MRI).
Objectives:
1. Evaluate first episode (FE) patients (neuroleptic naïve, if possible) comprehensively at intake and follow them longitudinally with regular serial assessments of clinical and psychosocial measures at six month intervals.
2. Evaluate chronic, and chronically medicated, patients.
3. Make cross-sectional comparisons of FE verses chronic patients to identify initial crude indicators of the course and outcome of schizophrenia, while the longitudinal data accumulate.
Methodology:
1. Two groups of schizophrenia subjects, FE and chronic, will be comprehensively assessed using the following: clinical descriptors, sociodemographic descriptors, a comprehensive cognitive assessment, morphometric Magnetic Resonance Imaging (mMRI), functional Magnetic Resonance Imaging (fMRI), Diffusion Tensor Imaging (DTI), MEG, and collection of blood for genetic studies.
2. Healthy volunteers will be recruited. The comparison and schizophrenia groups will be matched in age, gender composition, handedness, and parental socioeconomic status.
Drugs/Devices/Pharmaceuticals:
Subjects will undergo MRI using a 1.5 Tesla research scanner and MEG.
Type of Human Subject Involvement:
Subjects in this protocol will be normal volunteers and schizophrenia patients. Men and women of all racial and ethnic backgrounds will be included. Volunteers will usually be adult students and/or employees of the University of New Mexico. Exclusion criteria will be: 1) pregnancy, 2) presence of a potentially dangerous device, implanted or otherwise, 3) age less than 18, 4) presence of a medical condition that makes MR scanning dangerous, 5) claustrophobia, 6) weight greater than 300 pounds, and 7) uncontrolled incontinence. Informed consent will be obtained from subjects according to institutional guidelines established by the individual site.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: University of Iowa
Most recent approval: 09/06/06
IRB approval number: 199701024
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This is a multi-site longitudinal study that collected clinical, cognitive, genetic, morphometic, and functional neuroimaging data from schizophrenia patients and matched controls using a common experimental protocol across four participating sites, including the University of New Mexico, University of Minnesota, Massachusetts General Hospital (Boston), and University of Iowa. Studies conducted at these sites are part of the MIND Clinical Imaging Consortium (MCIC). The four projects involved in this effort are: MIND-04-510H-N1, MIND-04-533-N1, MIND-04-540-N2, and MIND-04-561-N1. At the University of Iowa, the project was conducted under three separate IRB protocols: 199701024 was put into place to draw blood from subjects for the project. The blood lines were immortalized and genetic material made available to investigators to search for the genomic variation that may constitute a significant proportion of the heritable factors in persons with schizophrenia.
Over the long-term, this network has amassed a large database of information accessible from all participating sites. The database enables the integration and cross validation of clinical, cognitive, morphometric, and functional neuroimaging results gathered from unique samples of schizophrenia patients using a common experimental protocol across all of the sites. By facilitating the integration of data obtained from multiple sites, the exploration of relationships is enabled between variables that otherwise would otherwise obscure significant effects by adding to the variability and noise in the data. The primary clinical aims of this multi-site project are to identify the neural substrates of the core cognitive deficits associated with schizophrenia, their link to the clinical features of the disorder, and their alterations with disease progression and treatment. Major changes to the protocol in 2006 include introduction of electroencephalography/magnetoencephalography (EEG/MEG) imaging (at the New Mexico site only), with results compared and contrasted with magnetic resonance imaging (MRI).
Objectives:
1. Evaluate first episode (FE) patients (neuroleptic naïve, if possible) comprehensively at intake and follow them longitudinally with regular serial assessments of clinical and psychosocial measures at six month intervals.
2. Evaluate chronic, and chronically medicated, patients.
3. Make cross-sectional comparisons of FE verses chronic patients to identify initial crude indicators of the course and outcome of schizophrenia, while the longitudinal data accumulate.
Methodology:
1. Two groups of schizophrenia subjects, FE and chronic, will be comprehensively assessed using the following: clinical descriptors, sociodemographic descriptors, a comprehensive cognitive assessment, morphometric Magnetic Resonance Imaging (mMRI), functional Magnetic Resonance Imaging (fMRI), Diffusion Tensor Imaging (DTI), MEG, and collection of blood for genetic studies.
2. Healthy volunteers will be recruited. The comparison and schizophrenia groups will be matched in age, gender composition, handedness, and parental socioeconomic status.
Drugs/Devices/Pharmaceuticals:
Subjects will undergo MRI using a 1.5 Tesla research scanner and MEG.
Type of Human Subject Involvement:
Subjects in this protocol will be normal volunteers and schizophrenia patients. Men and women of all racial and ethnic backgrounds will be included. Volunteers will usually be adult students and/or employees of the University of New Mexico. Exclusion criteria will be: 1) pregnancy, 2) presence of a potentially dangerous device, implanted or otherwise, 3) age less than 18, 4) presence of a medical condition that makes MR scanning dangerous, 5) claustrophobia, 6) weight greater than 300 pounds, and 7) uncontrolled incontinence. Informed consent will be obtained from subjects according to institutional guidelines established by the individual site.
"Spatiotemporal Dynamics of Context Processing in Schizophrenia"
Principal Investigator: Dr. Dara Manoach, Massachusetts General Hospital
Project started in: 2004
This project ended in fiscal year 2006.
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: Massachusetts General Hospital
Most recent approval: 03/01/05
IRB approval number: 2002P-000444
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This project identified the neural basis of the perseverative effects of inhibition in schizophrenia using a saccadic task. The research plan was structured on the hypothesis that successful inhibition, as measured by antisaccade (AS) performance, is increased with activation of frontal eye fields (FEF) and, in schizophrenia, this activity is exaggerated and compensatory brain regions recruited. In addition, as a secondary hypothesis, it was anticipated that the effects of inhibition would "carry-over." Trials preceded by inhibition, were characterized by decreased FEF activity and delayed responses. This effect was again exaggerated in schizophrenia patients. In 2005, functional magnetic resonance imaging/magnetoencephalography (fMRI/MEG) studies of 20 first episode (FE) patients, 20 chronic medicated patients, and 20 healthy subjects were conducted under this protocol.
"Use of Linguistic and Non-Linguistic Context in Language Comprehension in Schizophrenia"
Principal Investigator: Dr. Gina Kuperberg, Massachusetts General Hospital
Project started in: 2004
This project ended in fiscal year 2006.
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Massachusetts General Hospital
Most recent approval: 05/12/05
IRB approval number: 2000P-002100
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
Under this project, two functional magnetic resonance imaging (fMRI) experiments were conducted in patients with schizophrenia and matched healthy controls to compare the use of linguistic and non-linguistic context. The differences between patients and controls were identified in the spatiotemporal dynamics of activation within a left-lateralized temporal-prefrontal network. Also, the relationship between the observed neurophysiological abnormalities and clinical symptoms of schizophrenia were examined.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Massachusetts General Hospital
Most recent approval: 05/11/05
IRB approval number: 2000P-002107
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
Under this project, two functional magnetic resonance imaging (fMRI) experiments were conducted in patients with schizophrenia and matched healthy controls to compare the use of linguistic and non-linguistic context. The differences between patients and controls were identified in the spatiotemporal dynamics of activation within a left-lateralized temporal-prefrontal network. Also, the relationship between the observed neurophysiological abnormalities and clinical symptoms of schizophrenia were examined.
"Toward the Prevention of Schizophrenia: Neurobiological Studies of Families with Schizophrenia"
Principal Investigator: Dr. Larry Seidman, Massachusetts General Hospital
Project started in: 2004
This project ended in fiscal year 2006.
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Massachusetts General Hospital
Most recent approval: 04/28/05
IRB approval number: 1999P-008666/20
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This project was conducted to explore two objectives: First, to better identify the neural substrate of schizophrenia by identifying subsyndromal phenomenology that is transmitted in persons at risk for the illness. This was accomplished through focusing on cortical and limbic brain regions that have been identified previously as critical in understanding the vulnerability to schizophrenia, including the hippocampus, amygdale, parahippocampal and cingulated gyri, and dorsolateral and orbital prefrontal cortices, using structural and functional neuroimaging, as well as assessments of related attention, verbal declarative memory, working memory, and executive functions. Functional magnetic resonance imaging (fMRI) tasks were the measures of working memory and verbal encoding. The second objective was to identify the specificity of brain activation in persons with schizophrenia and their first-degree relatives, compared with persons with bipolar psychotic disorders and in their relatives. In 2005, the relationship of cognitive measures and brain activation was examined for approximately 30 subjects, 10 controls, 10 persons at genetic risk for psychoses, and 10 first-episode psychotic patients.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Massachusetts General Hospital
Most recent approval: 01/27/05
IRB approval number: 2002P-001984
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This project was conducted to explore two objectives: First, to better identify the neural substrate of schizophrenia by identifying subsyndromal phenomenology that is transmitted in persons at risk for the illness. This was accomplished through focusing on cortical and limbic brain regions that have been identified previously as critical in understanding the vulnerability to schizophrenia, including the hippocampus, amygdale, parahippocampal and cingulated gyri, and dorsolateral and orbital prefrontal cortices, using structural and functional neuroimaging, as well as assessments of related attention, verbal declarative memory, working memory, and executive functions. Functional magnetic resonance imaging (fMRI) tasks were the measures of working memory and verbal encoding. The second objective was to identify the specificity of brain activation in persons with schizophrenia and their first-degree relatives, compared with persons with bipolar psychotic disorders and in their relatives. In 2005, the relationship of cognitive measures and brain activation was examined for approximately 30 subjects, 10 controls, 10 persons at genetic risk for psychoses, and 10 first-episode psychotic patients.
"Auditory, Sensorimotor, and Language Area Mapping Using MEG With and Without fMRI Constraints"
Principal Investigator: Dr. Steve Stufflebeam, Massachusetts General Hospital
Project started in: 2004
This project ended in fiscal year 2006.
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Massachusetts General Hospital
Most recent approval: 08/02/05
IRB approval number: 2002P-001235/4
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This project continues an effort funded in 2004 to localize auditory function in schizophrenia using magnetoencephalography (MEG) and magnetic resonance imaging (MRI). In 2005, this experimental paradigm was further verified and optimized to improve the accuracy of the mapping technique, which has application in clinical pre-surgical mapping. In addition, the technique was applied to epilepsy patients and expanded to examine language mapping as well. The various mapping examinations involved from nine to 30 subjects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Massachusetts General Hospital
Most recent approval: 05/25/05
IRB approval number: 2002P-001238
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This project continues an effort funded in 2004 to localize auditory function in schizophrenia using magnetoencephalography (MEG) and magnetic resonance imaging (MRI). In 2005, this experimental paradigm was further verified and optimized to improve the accuracy of the mapping technique, which has application in clinical pre-surgical mapping. In addition, the technique was applied to epilepsy patients and expanded to examine language mapping as well. The various mapping examinations involved from nine to 30 subjects.
"In-Vivo Measurement of Glutamatergic Neurotransmission"
Principal Investigator: Dr. Kelvin O. Lim, University of Minnesota
Project started in: 2004
This project ended in fiscal year 2006.
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 Minnesota
Most recent approval: 02/16/05
IRB approval number: 0104M95501
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This project was conducted to develop the metabolic models that permit the extraction of glutamatergic neurotransmission rate in the brain using ultrahigh field C-13 spectroscopy. Ultimately, the Minnesota Partner Site plans to use this methodology to investigate glutamatergic neurotransmission in diseased states, such as schizophrenia, in which perturbations in glutamatergic neurotransmission rate has been postulated. In schizophrenia, NMDA receptor hypoactivity of GABAnergic neurons has been proposed to lead to reduced inhibition of the glutamatergic neurons, the most abundant excitatory neurons in the brain, and, thus, to increased glutamatergic neurotransmission. This project examined this prediction in vivo for the first time in animal models and subsequently in humans.
"The Disregulation of Optimized Cognition in Schizophrenia"
Principal Investigator: Dr. Tonya White, University of Minnesota
Project started in: 2004
This project ended in fiscal year 2006.
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 Minnesota
Most recent approval: 05/10/05
IRB approval number: 0205M25581
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This project represents phase one of a planned two-year project to study the neural networks modulated by the prefrontal cortex. In 2005, this project began with specific Aim #1 to study 80 healthy volunteers (8 to 25 years of age) using measures of control of attention and action, including working memory, using behavioral and eye-tracking measures. In addition, 30 youths with schizophrenia and 30 matched healthy controls were also studied, using both the tasks mentioned in specific Aim #1 (ages 8 to 25 years), and with a functional magnetic resonance imaging (fMRI) study of the Sternberg Item Recognition Paradigm (ages 8 to 17 years). Since the Sternberg Item Recognition Paradigm was utilized in the first episode study, this will provide data on the neurodevelopmental trajectory of the Sternberg in both schizophrenia and healthy volunteers. It is anticipated that these subjects will be re-tested in two years.
"Investigating Brain Function, Connectivity and Neurochemistry in Health and Disease: High Field Magnetic Resonance Methodologies"
Principal Investigator: Dr. Kamil Ugurbil , University of Minnesota
Project started in: 2004
This project ended in fiscal year 2006.
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: University of Minnesota
Most recent approval: 08/23/05
IRB approval number: 0210M34182
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
The general goal of this project in 2005 was the continued development and implementation of magnetic resonance methodologies for high resolution and high accuracy mapping of the neuronal function, functional connectivity, and cerebral energetics in the human brain. This general goal included (a) the development of improved, multinuclear, imaging, and spectroscopy techniques at ultra high magnetic fields (7 and 9.4 Tesla), (b) examination of mechanisms underlying imaging signals for mapping brain function, and (c) the use of this methodology to support studies in normal and diseased human brain. Specific accomplishments in 2005 included: imaging of cerebral blood flow (CBF) and CBF-based functional activation using continuous arterial spin tagging (CASL) techniques; instrument hardware and pulse sequence implementations to establish CASL on the Siemens 3T platform and to attain a state where such CBF weighted images were obtainable routinely; transfer of this methodology to the New Mexico Partner Site's 4T system running on the Siemens platform; establishing the same CBF imaging capability on the 7 Tesla system; development of a new pulse sequence that alleviated the specific absorption rate (SAR) (power deposition) limitation in spin echo functional magnetic resonance imaging (fMRI) to perform whole brain functional imaging on humans at 7 Tesla or higher fields; examination of this pulse sequence with respect to its functional imaging signal characteristics (spatial accuracy, and contrast-to-noise ratio (CNR)); evaluation of the sensitivity of this pulse sequence to different size blood vessels going from capillaries to draining veins using Monte-Carlo simulations; examination of this pulse sequence with respect to its multislice, whole brain coverage, and SAR; CNR in spin echo functional imaging at high fields; evaluation of array coils for parallel imaging and/or high sensitivity, high resolution imaging; functional imaging using parallel imaging with high reduction factors; spectroscopic studies of Alzheimer's Disease; and ultra-high field 9.4 Tesla imaging of the human brain.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: University of Minnesota
Most recent approval: 08/24/05
IRB approval number: 0409M3527
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
The general goal of this project in 2005 was the continued development and implementation of magnetic resonance methodologies for high resolution and high accuracy mapping of the neuronal function, functional connectivity, and cerebral energetics in the human brain. This general goal included (a) the development of improved, multinuclear, imaging, and spectroscopy techniques at ultra high magnetic fields (7 and 9.4 Tesla), (b) examination of mechanisms underlying imaging signals for mapping brain function, and (c) the use of this methodology to support studies in normal and diseased human brain. Specific accomplishments in 2005 included: imaging of cerebral blood flow (CBF) and CBF-based functional activation using continuous arterial spin tagging (CASL) techniques; instrument hardware and pulse sequence implementations to establish CASL on the Siemens 3T platform and to attain a state where such CBF weighted images were obtainable routinely; transfer of this methodology to the New Mexico Partner Site's 4T system running on the Siemens platform; establishing the same CBF imaging capability on the 7 Tesla system; development of a new pulse sequence that alleviated the specific absorption rate (SAR) (power deposition) limitation in spin echo functional magnetic resonance imaging (fMRI) to perform whole brain functional imaging on humans at 7 Tesla or higher fields; examination of this pulse sequence with respect to its functional imaging signal characteristics (spatial accuracy, and contrast-to-noise ratio (CNR)); evaluation of the sensitivity of this pulse sequence to different size blood vessels going from capillaries to draining veins using Monte-Carlo simulations; examination of this pulse sequence with respect to its multislice, whole brain coverage, and SAR; CNR in spin echo functional imaging at high fields; evaluation of array coils for parallel imaging and/or high sensitivity, high resolution imaging; functional imaging using parallel imaging with high reduction factors; spectroscopic studies of Alzheimer's Disease; and ultra-high field 9.4 Tesla imaging of the human brain.
"MEG Studies of Schizophrenia"
Principal Investigator: Dr. Apostolos Georgopoulos, University of Minnesota
Project started in: 2004
This project ended in fiscal year 2006.
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 Minnesota
Most recent approval: 01/01/05
IRB approval number: 2775-A
Explanation of IRB approval:
Project concluded 12/31/05. No effort involving human subjects took place during the reporting period 10/01/05 to 09/30/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
The general goal of this project was to use magnetoencephalography (MEG) to elucidate the dynamic brain mechanisms underlying sequential processing in schizophrenia at