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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00783913 |
This study will determine if electrical brain stimulation during movement practice can improve the ability of stroke patients to reach for objects more than movement practice alone.
People between 18 and 85 years old who have had a stroke may be eligible for this study. Participants are randomly assigned to one of two study groups: movement training with active (tDCS) or movement training with sham (tDCS).
Participants will undergo 1-hour movement training and (tDCS) sessions twice a day, 5 days a week, for 3 weeks. For these sessions, subjects will sit in front of a computer screen that shows a target (round dots) and a cursor (a line). Participants will be instructed to move the cursor to various targets on the computer screen as fast and as accurately as possible, controlling the position of the cursor by moving their arm, which will rest on a mechanical device.
Participants will receive real or sham (tDCS) during the movement training sessions. For (tDCS), electrode sponges soaked in tap water are placed on the scalp and forehead. A small electrical current is passed between the electrodes. The stimulation lasts 20 minutes.
Patients will have the following tests four times during the study - 1) before starting movement training 2) (tDCS) during the course of training and (tDCS), 3) after completing training and (tDCS), 4) and 3 months after completing training and (tDCS):
Functional magnetic resonance imaging (fMRI)
Magnetic resonance imaging (MRI) uses a magnetic field and radio waves to take pictures of the brain. Functional MRI (fMRI) shows what parts of the brain are used when a task is performed. For the test, the subject lies on a table that can slide in and out of the scanner. A computer screen can be seen from inside the scanner. During the scan, subjects may be asked to do the study task or to lie still for up to 20 minutes at a time.
Movement and function tests
Transcranial magnetic stimulation (TMS)
TMS uses a magnet to stimulate the brain in way that is different from (tDCS). This study us...
Condition | Intervention |
---|---|
Stroke |
Other: Visumotor Upper Extremity Training Other: Anodal/Sham tDCS |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Enhancing the Beneficial Effects of Upper Extremity Visuomotor Training With tDCS |
Estimated Enrollment: | 40 |
Study Start Date: | October 2008 |
Individuals who have suffered a stroke may benefit from the development of new rehabilitative interventions that can improve motor recovery after a stroke.
Objective:
The objective of this protocol is to test the hypothesis that active training on a complex upper extremity visuomotor task combined with anodal transcranial direct current stimulation (tDCS) used to activate the affected hemisphere improves functionality during reaching of the affected upper-extremity in comparison to training combined with sham tDCS in stroke patients.
The Study population:
The study population will include chronic (> 3 mo) stroke patients.
Design:
The study will follow a factorial design in which all subjects will undergo several sessions complex visuomotor task training of the upper extremity. One half of the patients will undergo anodal transcranial direct current stimulation during the first 20 minutes of each training session, while the control subjects will have sham stimulation applied.
Outcome Measures:
The primary outcome measure for the study is accuracy during completion of a reaching task. The primary endpoint for the study will be the end of 3 weeks of training (15 days). Secondary endpoint measures include timing of reach, kinematic, and functional measures. These measures
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
EXCLUSION CRITERIA:
Aphasia or language disturbances that would interfere with performing the study tasks
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 090021, 09-N-0021 |
Study First Received: | October 31, 2008 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00783913 |
Health Authority: | United States: Federal Government |
Direct Current Stimulation Rehabilitation Motor Learning Stroke |
Cerebral Infarction Stroke Vascular Diseases |
Central Nervous System Diseases Brain Diseases Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |