NCT00029718

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

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

January 16, 2002

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2002

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2006

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2011

Completed
Last Updated

July 2, 2017

Status Verified

November 18, 2011

First QC Date

July 14, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Chronic StrokeTranscallosal InhibitionMotor CortexMotor ControlMotor RecoveryHealthy VolunteerHVNormal Control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Boroojerdi B, Diefenbach K, Ferbert A. Transcallosal inhibition in cortical and subcortical cerebral vascular lesions. J Neurol Sci. 1996 Dec;144(1-2):160-70. doi: 10.1016/s0022-510x(96)00222-5.

    PMID: 8994119BACKGROUND
  • Bridgers SL, Delaney RC. Transcranial magnetic stimulation: an assessment of cognitive and other cerebral effects. Neurology. 1989 Mar;39(3):417-9. doi: 10.1212/wnl.39.3.417.

    PMID: 2927652BACKGROUND
  • Chen R, Gerloff C, Hallett M, Cohen LG. Involvement of the ipsilateral motor cortex in finger movements of different complexities. Ann Neurol. 1997 Feb;41(2):247-54. doi: 10.1002/ana.410410216.

    PMID: 9029074BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

July 14, 2006

First Posted

January 21, 2002

Study Start

January 16, 2002

Study Completion

November 18, 2011

Last Updated

July 2, 2017

Record last verified: 2011-11-18

Locations