NCT02455427.

Trial name or title	Safety of transcranial direct current stimulation in the subacute phase after stroke
Methods	RCT with parallel‐group design
Participants	Estimated enrolment: 40 Inclusion criteria: age between 18 and 80 years; ischaemic stroke, radiologically confirmed; onset between 72 hours and 6 weeks prior to enrolment; unilateral paresis of upper limb; NIHSS between 5 and 15; NIHSS score of at least 1 point in items 5a or 5b; written informed consent Exclusion criteria: lesions affecting the corticomotor pathway in the hemisphere contralateral to the stroke; use of neuroleptics or other psychoactive drugs; except antidepressants; advanced systemic diseases; other neurologic diseases except migraine; mRS < 2 prior to stroke; advanced systemic diseases; uncontrolled medical conditions; contraindications for physical therapy; pregnancy; absolute or relative contraindications for tDCS
Interventions	2 arms A‐tDCS over M1 of the affected hemisphere (for 20 minutes) followed by 60 minutes of physical therapy 3 times a week for 2 weeks Sham tDCS (for 20 minutes) followed by 60 minutes of physical therapy 3 times a week for 2 weeks
Outcomes	Primary outcome measures Frequency of adverse events at 2 weeks Secondary outcome measures Change in mRS at 2 and 14 weeks Change in NIHSS at 2 and 14 weeks Change in SIS at 2 and 14 weeks Change in UE‐FM at 2 and 14 weeks Change in MAS at 2 and 14 weeks Change in MAL at 2 and 14 weeks MoCA at 2 and 14 weeks Structural connectivity (measured by DTI) at 2 weeks Functional connectivity (measured by resting‐state fMRI) at 2 weeks Change in BI at 2 and 14 weeks Frequency of adverse events at 14 weeks
Starting date	May 2015
Contact information	Adriana B Conforto, MD Phd Hospital Israelita Albert Einstein Brazil
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