Interhemispheric Interactions Associated With Performance of Voluntary Movements in Patients With Stroke Motor Disability

June 30, 2017 updated by: National Institute of Neurological Disorders and Stroke (NINDS)

This study will use transcranial magnetic stimulation (TMS) to identify interactions between the unaffected and affected side of the brain in stroke patients. Results from previous studies suggest that after a stroke, the motor cortex (part of the brain that controls movement) of the unaffected side of the brain might negatively influence the motor cortex of the affected side. TMS is a procedure that delivers brief electrical currents that stimulate the brain. Studies of a small number of patients have shown that TMS can cause a temporary decrease in activity of the motor cortex.

Healthy normal volunteers and chronic stroke patients may be eligible for this study. Subjects may participate in up to four sessions of reaction time (speed of motor response) testing. They will perform a series of movements with the index and middle fingers of either the left or right hand in response to a signal from a computer monitor. The time it takes to do the tasks will be measured and scored. There will be rest periods during each session.

TMS will be done each session to examine how the motor cortex affects recovery of function after stroke. For this procedure, an insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. Depending on where the coil is placed, the stimulation may cause a muscle twitch (sometimes strong enough to move the limb), a feeling of movement or tingling in a limb, or twitching of the jaw. During stimulation, the subject may be asked to tense certain muscles slightly or to perform other simple actions. The electrical activity in the muscles activated by the stimulation will be recorded using metal electrodes taped to the skin over the muscles.

Subjects will also be asked to draw a mark on a line on paper to rate their attention and level of fatigue, and how well they think they are executing the tasks.

Participants will also have magnetic resonance imaging (MRI). This procedure uses a strong magnetic field and radio waves to provide detailed images of the brain. During the scanning, the subject wears earplugs to muffle loud thumping sounds that occur with electrical switching of the radio frequency circuits. The subject can communicate with the staff member performing the study at all times through an intercom system.

Study Overview

Status

Completed

Conditions

Detailed Description

Performance of accurate skilled movements relies on interhemispheric interactions between the two motor cortices. It has been proposed that abnormal interactions could contribute to the motor deficit that results from chronic hemispheric lesions after stroke. The purpose of this protocol is to identify changes in interhemispheric inhibitory interactions associated with performance of a motor task in patients with chronic hemispheric stroke. The overall hypothesis is that the cortical representation of the paretic hand receives abnormally high task-related interhemispheric inhibitory influence originated in the intact motor cortex in stroke patients relative to healthy volunteers. It is important to test this hypothesis, because if proven correct, it could lead to the development of novel neurorehabilitative strategies.

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:
  • Age 21 and above
  • Willingness and ability to perform all tasks as requested
  • For stroke patients, history of one, unilateral stroke greater than 6 months prior to enrollment, with initial hand paresis that has recovered to the point of being able to perform the motor task

EXCLUSION CRITERIA:

  • Inability to perform any of the requested tasks
  • Folstein mini-mental state exam (Folstein. 1976) score of 23 or less.

Diagnosis of 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

  • Diagnosis of alcohol dependence at the time or in the six months prior to participation as made by a community or NIH independent licensed practitioner
  • Diagnosis of major depressive disorder at the time or in the six months prior to participation as made by a community or NIH independent licensed practitioner
  • Pacemakers, implanted pumps, or stimulators, such as cochlear implants or metal objects inside the eye or skull aside from dental implants
  • Metal in the cranium except mouth
  • Metal fragments from occupational exposure or surgical clips in or near the brain
  • Eye, blood vessel, cochlear or eye implants
  • History of epilepsy
  • Pregnancy
  • For healthy volunteers, diagnosis of any neurologic disorder as made by a community or NIH independent licensed practitioner
  • For healthy volunteers, active use of any anti-depressant, anti-convulsive, neuroleptic, or psycho-stimulant medications
  • For stroke patients: more than one stroke, brainstem or cerebellar stroke, or any history of bilateral paresis
  • Lack of capacity to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 16, 2002

Study Completion

November 18, 2011

Study Registration Dates

First Submitted

July 14, 2006

First Submitted That Met QC Criteria

January 18, 2002

First Posted (Estimate)

January 21, 2002

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

November 18, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020104
  • 02-N-0104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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