NCT01143649.

Trial name or title	Effects of transcranial DC stimulation coupled with constraint induced movement therapy on motor function in stroke patients
Methods	Double‐blind RCT (parallel‐group design)
Participants	120 people between 18 and 90 years of age: 40 of whom have first‐time ever clinical ischaemic or haemorrhagic cerebrovascular accident confirmed by a radiological or physician's report, with weakness less than 55 (out of 66) on the UE‐FM scale; stroke onset > 6 months before study enrolment. The remaining 80 people are healthy volunteers Exclusion criteria: significant prestroke disability, major depression; any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing; excessive pain in any joint of the paretic extremity (not applicable to severe stroke patients), contraindications to single pulse TMS (TMS will be used to measure cortical excitability); contraindications to tDCS, advanced liver, kidney, cardiac or pulmonary disease; terminal medical diagnosis consistent with survival < 1 year; coexistent major neurological or psychiatric disease; history of significant alcohol or drug abuse in the prior 6 months; use of carbamazepine and amitriptyline; patients may not be actively enrolled in a separate intervention study targeting stroke recovery and prior CIMT and/or tDCS treatment for stroke; history of epilepsy before stroke; patients with global aphasia and deficits of comprehension; pregnancy
Interventions	Experimental 1: tDCS + CIMT in stroke participants (40 people), tDCS over M1; intensity 1 mA, for the first 40 minutes of 10 consecutive sessions of CIMT (Monday to Friday) Experimental 2: tDCS + motor training in healthy participants (40 people); 1 day of treatment (when the order in which they receive sham or active tDCS stimulation will be randomly assigned). Each stimulation day will include up to 6 hours of training termed "shaping" in the non‐dominant hand, while the dominant hand is restrained in a resting hand splint and is secured in a sling. At the start of this training, participants will undergo 40 minutes of real tDCS at 1 mA or sham tDCS Active comparator: tACS 40 healthy participants, 1 day of treatment (when the order in which they receive sham or active transcranial alternating current stimulation (tACS) stimulation will be randomly assigned), stimulated at 1 mA for 40 minutes
Outcomes	Primary outcome measures: motor function as measured by JTT, MAS, UE‐FM, BI at 2 weeks after the end of the intervention period Secondary outcome measures: cortical excitability measured by MEP and the resting motor threshold, intracortical excitability by paired‐pulse and also transcallosal inhibition to measure interhemispheric differences
Starting date	April 2010
Contact information	Location: Spaulding Rehabilitation Hospital, Boston, Massachusetts, 02114, USA Investigator: Felipe Fregni, PhD
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