NCT01574989.

Trial name or title	Effects of repetitive transcranial magnetic stimulation and transcranial DC stimulation on motor function in stroke patients
Methods	Double‐blind randomised controlled cross‐over trial
Participants	26 people 18 to 90 years of age Additional inclusion criteria for stroke participants: first‐time ever clinical ischaemic or haemorrhagic cerebrovascular events as evidenced by a radiological (or physician's) report; weakness, defined as score of less than 55 (out of 66) on UE‐FM scale; stroke onset > 6 months before study enrolment Exclusion criteria: history of major depression, BDI > 30, any substantial decrease in alertness, language comprehension, or attention that might interfere with understanding instructions for motor testing; contraindications to TMS/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 substance abuse in the prior 6 months, patients may not be actively enrolled in a separate intervention study targeting stroke recovery and any other clinical trials, patients with global aphasia and deficits of comprehension, pregnancy, neuropsychotropic medication (healthy people only) Additional exclusion criteria for stroke patients: patients may not have already received TMS and/or tDCS stimulation for stroke, history of epilepsy before stroke or episodes of seizures within the last 6 months
Interventions	Participants will receive 5 sessions of stimulation. They will undergo (1) active low‐frequency rTMS (1 Hz continuous), (2) active high‐frequency rTMS (10 Hz, 2‐second trains with intertrain interval of 28 seconds) or (3) sham rTMS (using a sham coil). Each session will last 20 minutes and will be conducted at 100% of the motor threshold. Each tDCS session will last 20 minutes and will be conducted using 1 mA with 35 cm² electrodes Experimental 1: single session of active low‐frequency rTMS/sham tDCS on the scalp during the 20‐minute session Experimental 2: single session of active high‐frequency rTMS/sham tDCS on the scalp during the 20‐minute session Experimental 3: single session of sham rTMS/active anodal tDCS on the scalp during the 20‐minute session Experimental 4: single session of sham rTMS/active C‐tDCS on the scalp during the 20‐minute session Sham comparator: single session of sham rTMS/sham tDCS on the scalp during the 20‐minute session
Outcomes	Primary outcome measures: changes in cortical excitability measures using single‐ and paired‐pulse TMS before and after each single stimulation session Secondary outcome measures: changes in motor function as measured by behavioural tasks (e.g. Purdue pegboard, JTT, ROM) both before and after the stimulation sessions Time frame: measured for approximately 6 weeks
Starting date	May 2011
Contact information	Felipe Fregni, MD, PhD, MPH, ffregni@partners.org Kayleen M Weaver, BA, kmweaver@partners.org
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