Role of the Intact Hemisphere in Recovery of Motor Function After Stroke

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
Overall Status
Completed
CT.gov ID
NCT00028184
Collaborator
(none)
80
1
36
2.2

Study Details

Study Description

Brief Summary

The purpose of this study is to better understand the role of the motor part of the brain in the recovery of motor function after stroke. The motor deficits that follow a stroke are compensated for over several months. It has been proposed that the ipsilateral motor cortex mediates these recovery processes. The results of this study will provide fundamental information on the role of ipsilateral M1 in recovery of motor function after chronic stroke.

A general patient evaluation will determine the location of the lesion site and assess the degree of impairment in motor and global cognitive functioning. An assessment of motor function will also be performed. Patients will be divided into two groups: well and poorly recovered. An MRI (magnetic resonance imaging) scan may also be done if one has not been performed in the past 6 months.

Two main procedures will be performed: transcranial magnetic stimulation (TMS) and test of motor performance. In the first procedure, a metal coil surrounded by a plastic mold will be placed on the head and electrical current will be pulsed through it. The electrical muscle activity will be recorded through these electrodes with a computer. The second procedure involves a reaction time test. The task will consist of reacting to a visual stimulus by performing a voluntary movement. TMS pulses will be given before each movement. This is done to determine whether this type of stimulation interferes with reaction time, which would indicated that it interferes with the brain centers executing the reaction to the visual Go-signal.

Patients with single ischemic hemispheric lesions at least 12 months after the stroke who initially had a severe paralysis of the arm will be recruited for the study. Healthy normal volunteers will also be included in the study. A special effort will be made to increase the participation of women and diverse racial groups.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    It has been proposed that recovery of motor function of the paretic arm following stroke is mediated by the ipsilateral (intact) motor cortex (M1). This proposal has not been conclusively tested experimentally and represents an important question in stroke rehabilitation. In this protocol, we will study the behavioral consequences of transient inactivation of ipsilateral M1 on motor performance of the affected arm in chronic stroke patients with complete and incomplete motor recovery. The results from this study will provide fundamental information on the role of ipsilateral M1 in recovery of motor function after chronic stroke.

    Study Design

    Study Type:
    Observational
    Official Title:
    Role of the Intact Hemisphere in Recovery of Motor Function After Stroke
    Study Start Date :
    Dec 1, 2001
    Study Completion Date :
    Dec 1, 2004

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      INCLUSION CRITERIA:

      Patients with single ischemic hemispheric lesions at least 12 months after the stroke who had a severe paresis (below MRC grade 2) of the affected arm initially. An anatomical MRI scan will be acquired at the NIH if a recent one (within 6 months) is not available.

      Normal volunteers who are willing and able to perform the tasks will be included in the study. Healthy normal volunteers recruited for the study will receive neurological and physical exams to ensure their healthy conditions.

      EXCLUSION CRITERIA:

      Patients with more than one stroke.

      Patients with bilateral motor impairment.

      Patients with cerebellar or brainstem lesions.

      Patients or subjects unable to perform the task (wrist or elbow flexion at least MRC grade 2).

      Patients or subjects with history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 20 or less).

      Patients or subjects with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, uncontrolled epilepsy or others).

      Patients or subjects with metal in the cranium except mouth.

      Patients or subjects with dental braces, metal fragments from occupational exposure or surgical clips in or near the brain.

      Patients or subjects with eye, blood vessel, cochlear or eye implants.

      Patients or subjects with increased intracranial pressure as evaluated by clinical means.

      Patients with cardiac or neural pacemakers, intracardiac lines and/or implanted medication pumps.

      Patients or subjects with history of loss of consciousness or epilepsy.

      Patients or subjects with unstable cardiac dysrhythmia.

      Patients or subjects with h/o hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 National Institute of Neurological Disorders and Stroke (NINDS) Bethesda Maryland United States 20892

      Sponsors and Collaborators

      • National Institute of Neurological Disorders and Stroke (NINDS)

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00028184
      Other Study ID Numbers:
      • 020078
      • 02-N-0078
      First Posted:
      Dec 18, 2001
      Last Update Posted:
      Mar 4, 2008
      Last Verified:
      Dec 1, 2004

      Study Results

      No Results Posted as of Mar 4, 2008