Study of Brain Changes Shaped by Experience
|First Received Date ICMJE||October 28, 2000|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||October 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00006424 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Study of Brain Changes Shaped by Experience|
|Official Title ICMJE||fMRI and Spectroscopy Studies of Cortical Plasticity at 1.5 and 3 Tesla|
This study will use magnetic resonance imaging (MRI) scans to explore how the brain changes (reorganizes itself) in response to learning and to brain lesions in healthy people and people with various physical disabilities.
Normal volunteers and patients with disabilities including blindness, limb amputation, hemispherectomy (removal of a cerebral hemisphere), and stroke may be eligible for this study. Candidates will be screened with medical and neurological examinations.
Participants will have MRI scans while they lie still or perform certain movements, as instructed. MRI uses a strong magnetic field and radio waves instead of X-rays to show structural and chemical changes in tissues. During the scan, the subject lies on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff member through an intercom system at all times during the procedure. All participants will first have a scan to show brain structure, which will take about 30 minutes. A second scan will measure blood flow or biochemical concentration and will take from 1 to 2 1/2 hours.
Depending on their disability, patients will participate in one of the following tests:
Normal volunteers will participate in one of the following tests:
The purpose of this protocol is to investigate plastic changes in human cerebral cortex in health and disease. The overall hypothesis is that it is possible to identify neuroimaging patterns reflecting reorganization in the human cerebral cortex using fMRI and that it is possible to obtain information on the mechanisms underlying some of these plastic changes by using magnetic resonance spectroscopy (MRS) of GABA. This information is potentially important for the understanding of mechanisms of cortical reorganization operating in humans. Patients and normal volunteers will be scanned at rest and during performance of different tasks. These studies should provide new information on mechanisms of human plasticity. The MRI techniques used for that purpose are functional MRI (fMRI), MR spectroscopy (MRS), and conventional MRI with magnets between 1.5 and 4 tesla.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Merzenich MM, Kaas JH, Wall JT, Sur M, Nelson RJ, Felleman DJ. Progression of change following median nerve section in the cortical representation of the hand in areas 3b and 1 in adult owl and squirrel monkeys. Neuroscience. 1983 Nov;10(3):639-65.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||January 2002|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients must be able to give informed consent.
Patients recruited would come from those referred to the Human Cortical Physiology Section who would have distinct neurological syndromes from well-defined peripheral and central nervous system lesions including stroke, hemipherectomy, and amputation.
Healthy adults without history of neurological disease.
Pregnant women will be excluded.
Subjects with metal in the cranium except mouth will be excluded.
Subjects with dental braces will be excluded.
Subjects with metal fragments from occupational exposure or surgical clips in or near the brain will be excluded.
Subjects with eye, blood vessel, cochlear or eye implants will be excluded.
Subjects with increased intracranial pressure as evaluated by clinical means will be excluded.
Subjects with cardiac or neural pacemakers will be excluded.
Subjects with intracardiac lines and implanted medication pumps will be excluded.
ADDITIONAL INCLUSION CRITERIA WHEN AMPHETAMINE IS USED:
Subjects with large hemorrhagic or brain stem stroke will be excluded.
Subjects with multiple cerebral lesions with residual deficits will be excluded.
Subjects with history of head injury with loss of consciousness will be excluded.
Subjects with history of severe alcohol or drug abuse will be excluded.
Subjects with history of psychiatric illness will be excluded.
Subjects with unstable cardiac dysrhythmia or unresponsive arterial hypertension (greater than 160/100 mmHg) will be excluded.
Subjects with history of hyperthyroidism will be excluded.
Subjects receiving alpha-adrenergic antagonists or agonist, major/minor tranquilizers, clonidine, prazosin, phenytoin, benzodiazepines, scopolamine, haloperidol, other neuroleptics, barbiturates will be excluded.
Subjects with glaucoma, history of hypersensitivity or idiosyncrasy to sympatomimetic drugs will be excluded.
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00006424|
|Other Study ID Numbers ICMJE||010012, 01-N-0012|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 2002|
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