NCT01007136.

Trial name or title	TDCS‐enhanced stroke recovery and cortical reorganisation
Methods	Double‐blind randomised controlled trial in parallel‐group design
Participants	150 people with single ischaemic stroke between 18 and 80 years of age with arm weakness between 5 and 15 days poststroke and no other neurological or psychiatric diseases Exclusion criteria: people with bilateral motor impairment, with poor motivational capacity or history of severe alcohol or drug abuse, people with severe aphasia, MMSE Score < 23; people with severe uncontrolled medical problems (e.g. seizures, progressive stroke syndromes, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, end‐stage pulmonary or cardiovascular disease, a deteriorated condition due to age or others); people with unstable thyroid disease; people with increased intracranial pressure; people with unstable cardiac arrhythmia; people with contraindication to TMS or tDCS stimulation (pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull, patients who had a craniotomy, skin lesions at the site of stimulation); people who are not available for follow‐up at 3 and 12 months; pregnancy; people with contraindication to MRI will not participate in MRI
Interventions	Experimental: tDCS and occupational therapy: 1 mA electrical current will be delivered over M1 of the lesioned hemisphere for the first 20 minutes during the 1‐hour physical therapy  Sham comparator: sham and occupational therapy: electrical current will be ramped up and down over M1 of the lesioned hemisphere for the first seconds during the 1 hour physical therapy
Outcomes	Primary outcome measures: UE‐FM at 2 weeks, 3 months and 1 year after stroke Secondary outcome measures: JTT at 2 weeks, 3 months and 1 year after stroke; WMFT at 2 weeks, 3 months and 1 year after stroke; MRC grading scale at 2 weeks, 3 months and 1 year after stroke; BI at 2 weeks, 3 months and 1 year after stroke; Abilhand questionnaire at 2 weeks, 3 months and 1 year after stroke; Ashworth Spasticity Scale at 2 weeks, 3 months and 1 year after stroke; Beck Depression Inventory at 2 weeks, 3 months and 1 year after stroke; Visual Analog Pain Scale at 2 weeks, 3 months and 1 year after stroke; Mini Mental Status Scale at 2 weeks, 3 months and 1 year after stroke; NIHSS at 2 weeks, 3 months and 1 year after stroke; Motor Activity Log at 2 weeks, 3 months and 1 year after stroke; fMRI overactivation in motor cortex: voxel count and intensity at 2 weeks, 3 months and 1 year after stroke
Starting date	March 2009
Contact information	Timea Hodics, MD Timea.Hodics@UTSouthwestern.edu Charlotte Bentley Charlotte.Bentley@UTSouthwestern.edu
Notes