NCT00542256.

Trial name or title	Effects of transcranial direct current stimulation coupled with constraint‐induced movement therapy on motor function in stroke patients
Methods	Double‐blind RCT
Participants	50 people 18 to 80 years of age with radiologically confirmed first‐time ever ischaemic or haemorrhagic stroke; at least 6 months prior to study enrolment, demonstrating adequate balance with the non‐lesioned arm restraint and the ability to stand up from sitting and to stand without help of the upper extremity  Exclusion criteria: significant prestroke disability, neuropsychological impairments that hinder motor testing, considerable joint pain in the paretic extremity, life expectancy less than 1 year because of terminal medical diagnosis, advanced disease of viscera, considerable neurological or psychiatric disease, history of substance abuse, use of neuropsychotropic drugs, inability to enrol in another study targeting stroke recovery, prior admittance of CIMT or tDCS
Interventions	Experimental group: 40 minutes of tDCS over M1 at the beginning of 10 of 14 consecutive up to 6 hours lasting CIMT training sessions Control group: 30 seconds of tDCS over M1 at the beginning of 10 of 14 consecutive up to 6 hours lasting CIMT training sessions
Outcomes	Primary outcome measures: Jebsen Taylor Hand Function Test at baseline, training days 1, 5, and 10 and follow‐up; Motor Activity Log Rating Scale at baseline, training days 1, 5, and 10 and follow‐up; Beck Depression Inventory at baseline, training days 1, 5, and 10 and follow‐up; Visual Analogue Scale for Anxiety at baseline, training days 1, 5, and 10 and follow‐up Secondary outcome measures: Fugl‐Meyer Assessment of Motor Recovery at baseline; Barthel Index Score at baseline; Modified Ashworth Scale at baseline
Starting date	September 2007
Contact information	Julie A Williams, MSc 617‐667‐5261 jawillia@bidmc.harvard.edu
Notes	Last updated: 9 May 2008