NCT00783913.
Trial name or title | Enhancing the beneficial effects of upper extremity visuomotor training with tDCS |
Methods | Double‐blind RCT in a parallel‐group design |
Participants | 18 people 18 to 85 years of age with ability to sit and be active for an hour on a chair/wheelchair without cardiac, respiratory and/or pain disturbances as assessed during the screening visit; willingness to commit to participate in the long‐term follow‐up study (up to 3 months); willingness to give written informed consent; diagnosis of a first clinically apparent unilateral cortical or subcortical stroke at least 3 months before study entry Exclusion criteria: history of severe neurological illness, severe cognitive impairment (MMSE < 23); MRI contraindications; history of alcohol or drug abuse; active depression with psychoactive medication changes in the last 2 months, active psychosis, disruptive or violent behavior, poor motivational capacity; aphasia or language disturbances that would interfere with performance of study tasks; uncontrolled medical problems; increased intracranial pressure; severe neglect or ataxia that would interfere with completion of study tasks; history of more than one stroke or a stroke that affects both sides of the brain, the brainstem or the cerebellum; inflammation of the tissue, severe rheumatoid arthritis or abnormal function of the joints due to arthritis in the affected arm used most often; pregnancy |
Interventions | Baseline intervention: 1‐hour computerised movement training and tDCS sessions twice a day, 5 days a week, for 3 weeks. Participants 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, while controlling the position of the cursor by moving their arm, which will rest on a mechanical device Experimental: A‐tDCS stimulation during the first 20 minutes of each training session; electrode sponges soaked in tap water are placed on the scalp and forehead Control: sham tDCS |
Outcomes | Primary outcome measures: accuracy (defined as the difference between the straight line connecting the origin and the target and the line followed by the participant) during reaching. 1 of the additional outcomes is the time to complete a reaching task Secondary outcome measures: UE‐FM |
Starting date | October 2008 |
Contact information | National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, USA |
Notes |