NCT00426465

Brief Summary

This study will explore the optimum training schedule for stroke patients to learn motor skills. It will see if motor training is more effective when training sessions are distributed over time (spaced training) or when the sessions are scheduled close together (massed training). The results of this study may help researchers devise the best training schedule for patients to derive the maximum benefit from rehabilitation therapy. Healthy normal volunteers and people who have had a stroke may be eligible for this study. Patients must be 3 months post-stroke. All participants must be right-handed and between 18 and 80 years of age. Participants practice a pinch motor task and receive transcranial magnetic stimulation (TMS). Hand muscle activity is measured using surface electromyography (EMG). Pinch training involves training the participant to pinch as strongly as possible, using a device that records the force. For TMS, a wire coil is held on the subject s scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm or leg. For surface EMG, electrodes (small metal disks) are filled with a conductive gel and taped to the skin over the muscle. Following one practice session of pinch task training and TMS, participants have four training sessions, which are scheduled 24 hours, 2 weeks, 1 month and 3 months after the practice session. For the 4- to 5-hour practice session, subjects do the following:

  • Perform a single session of pinch motor task for familiarization
  • Undergo TMS to measure brain activity
  • Practice five 6-minute blocks of pinch motor task with rest periods between sessions and perform a calculation task (addition and subtraction tasks) during each rest period
  • Receive TMS over 15 minutes. (Some sessions may have sham TMS.)
  • Read books and magazines during a 45-minute rest period
  • Perform a single block of the pinch motor task
  • Undergo TMS to measure brain activity
  • Complete a questionnaire that measures attention, fatigue and mood For the remaining four sessions, participants perform one practice block and TMS. Each session lasts about 2 hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

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 17, 2007

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2007

Completed
6.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2013

Completed
Last Updated

December 17, 2019

Status Verified

December 16, 2013

First QC Date

January 23, 2007

Last Update Submit

December 14, 2019

Conditions

Keywords

Motor PracticeMagnetic StimulationStrokeSpacing EffectMassed PracticeHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-80 years
  • Able to perform tasks required by the study\<TAB\>
  • Willing and able to give consent
  • Have a normal physical and neurological examination
  • Right Handed as assessed by the Edinburgh inventory scale (Edinburgh, 1971)

You may not qualify if:

  • History of alcohol or drug abuse, and psychiatric illness such as severe depression.
  • Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants.
  • Patients must be between the ages of 18 and 80 years of age, inclusive. Included will be those with chronic (more than 3 months) stroke who recovered motor function to the point of being able to perform the ballistic pinch force task. Stroke patients will be recruited through the NIH Clinical Research Volunteer Program. Assessment of severity of initial hemiparesis will be taken either from patient report or medical records.
  • EXCLUDED FROM THE STUDY WILL BE PATIENTS:
  • with a history of severe alcohol or drug abuse, psychiatric illness like severe depression, severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam (Folstein, 1976) score of 23 or less)
  • 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)
  • with metal in the body (metal in the cranium, metal fragments from occupational exposure, surgical clips in or near the brain, cardiac or neural pacemakers, intracardiac lines, implanted medication pumps, blood vessel, cochlear or eye implants)
  • with history of loss of consciousness or epilepsy
  • with history of hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants.

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)

  • Bermpohl F, Fregni F, Boggio PS, Thut G, Northoff G, Otachi PT, Rigonatti SP, Marcolin MA, Pascual-Leone A. Left prefrontal repetitive transcranial magnetic stimulation impairs performance in affective go/no-go task. Neuroreport. 2005 Apr 25;16(6):615-9. doi: 10.1097/00001756-200504250-00020.

    PMID: 15812319BACKGROUND
  • Bermpohl F, Fregni F, Boggio PS, Thut G, Northoff G, Otachi PT, Rigonatti SP, Marcolin MA, Pascual-Leone A. Effect of low-frequency transcranial magnetic stimulation on an affective go/no-go task in patients with major depression: role of stimulation site and depression severity. Psychiatry Res. 2006 Jan 30;141(1):1-13. doi: 10.1016/j.psychres.2005.07.018. Epub 2005 Dec 13.

    PMID: 16352348BACKGROUND
  • 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

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Leonardo G Cohen, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

January 23, 2007

First Posted

January 24, 2007

Study Start

January 17, 2007

Study Completion

December 16, 2013

Last Updated

December 17, 2019

Record last verified: 2013-12-16

Locations