NCT00067197

Brief Summary

No universally successful therapy exists that promotes recovery of motor function after a stroke, the main cause of long-term disability among adults. The purpose of this study is to develop strategies to improve recovery of lost motor function. It will combine motor skills training with a brain-stimulating technique called transcranial direct current stimulation (tDCS). Healthy adult volunteers and adult stroke patients will be enrolled in this study. Participants will come to NIH for a clinical and neurological exam, and, if necessary, an MRI \[magnetic resonance imaging\] examination. Participants will return for 4 sessions; each lasting approximately 3 hours. The first will be a practice session during which participants will become familiar with the motor skills required of them in this study, such as performing finger movements on a keyboard, pinching, tapping, making wrist movements, and lifting small items. In sessions 2 and 3, participants will perform the motor skills they practiced in session 1 while receiving tDCS. During session 4, they will receive tDCS only, with no performance of motor skills. During tDCS, investigators will place electrodes with a gel on participants' heads and pass the tDCS current between these two electrodes. tDCS is a painless procedure. Participants will receive up to $420 in compensation for their involvement in this study. ...

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2003

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

August 11, 2003

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 12, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2003

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2008

Completed
Last Updated

July 2, 2017

Status Verified

July 17, 2008

First QC Date

August 12, 2003

Last Update Submit

June 30, 2017

Conditions

Keywords

Transcranial Direct Current Stimulation (tDCS)Cortical ReorganizationRehabilitationMotor LearningActivity of Daily Living (ADL)StrokeHealthy VolunteerHV

Eligibility Criteria

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

You may qualify if:

  • We will include patients with thromboembolic non-hemorrhagic hemispheric lesions at least 3 months after the stroke.
  • We will choose Patients who initially had a severe motor paresis (below MRC grade 2), which subsequently recovered to the point that they have a residual motor deficit but can perform the required tasks. Assessment of the initial functional state will be taken either from patient report or medical records.
  • As the control group, we will include age- and gender matched Normal Volunteers with matched non-dominant/dominant hand (to the affected hand of the stroke patients).

You may not qualify if:

  • Patients with more than one stroke in the medical cerebral artery territory.
  • Patients with bilateral motor impairment.
  • Patients with cerebellar or brainstem lesions.
  • Patients or Normal Volunteers unable to perform the task (wrist or elbow flexion at least MRC grade 2).
  • Patients or Normal Volunteers with 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 23 or less).
  • Patients or Normal Volunteers with history 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, uncontrolled epilepsy or others).
  • Patients or Normal Volunteers with increased intracranial pressure as evaluated by clinical means.
  • Patients or Normal Volunteers with unstable cardiac arrhythmia.
  • Patients or Normal Volunteers with h/o hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system.
  • Patients and Normal Volunteers with more than moderate to severe microangiopathy, polyneuropathy, diabetes mellitus, or ischemic peripheral disease.
  • Patients or Normal Volunteers which are or which have been professional piano players.
  • Pregnancy.

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)

  • Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.

    PMID: 11723286BACKGROUND
  • Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.

    PMID: 10990547BACKGROUND
  • Karni A, Meyer G, Jezzard P, Adams MM, Turner R, Ungerleider LG. Functional MRI evidence for adult motor cortex plasticity during motor skill learning. Nature. 1995 Sep 14;377(6545):155-8. doi: 10.1038/377155a0.

    PMID: 7675082BACKGROUND

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

August 12, 2003

First Posted

August 13, 2003

Study Start

August 11, 2003

Study Completion

July 17, 2008

Last Updated

July 2, 2017

Record last verified: 2008-07-17

Locations