NCT00006424

Brief Summary

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:

  • Blindness-This will study the ability of blind people to process tactile information.
  • Stroke- This will study mechanisms underlying recovery of motor function after stroke. The patient will perform voluntary movements or remain still during the scan.
  • Amputation- This will study mechanisms underlying the ability of the brain to reorganize after amputation. The patient will move different parts of the body or remain still during the scan.
  • Hemispherectomy- This will study mechanisms underlying the ability of one side of the brain to control movements of both arms. The patient will make different kinds of movements during the scan. Normal volunteers will participate in one of the following tests:
  • Use-dependent plasticity- This will evaluate the effectiveness of amphetamine and placebo in demonstrating brain flexibility. The volunteer will take an amphetamine or placebo (inactive pill) before the scan and then perform a specific exercise using the thumb.
  • Motor fatigue- This will study the mechanisms that underlie fatigue, which affect many patients with neurological conditions. The volunteer will contract muscles in the forearm and hand for several minutes until he or she feels fatigue.
  • Light deprivation- This will evaluate changes in the brain that occur after light deprivation. The volunteer will remain at rest in the scanner for up to 150 minutes.
  • Somatosensory stimulation-This will examine whether stimulation of the wrist can cause changes in hand representation in the part of the brain that controls movement. The volunteer will make hand movements at different times during the test. In addition, mild electric shocks will be delivered to the wrist for up to 2 hours. Although the shock intensity is regulated to avoid pain, there may be some discomfort.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2000

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2000

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
Last Updated

March 4, 2008

Status Verified

January 1, 2002

First QC Date

October 28, 2000

Last Update Submit

March 3, 2008

Conditions

Keywords

PlasticityMotorStrokeAmphetaminefMRICortical ReorganizationSpectroscopy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • 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. doi: 10.1016/0306-4522(83)90208-7.

    PMID: 6646426BACKGROUND

MeSH Terms

Conditions

Neurologic ManifestationsStroke

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

October 28, 2000

First Posted

October 30, 2000

Study Start

October 1, 2000

Study Completion

January 1, 2002

Last Updated

March 4, 2008

Record last verified: 2002-01

Locations