NCT01726673.

Trial name or title	Effects of transcranial direct current stimulation paired with robotic arm therapy on recovery of upper extremity motor function in stroke patients
Methods	Double‐blind RCT (parallel assignment)
Participants	66 people 18 years of age or older with first single focal unilateral lesion as verified by brain imaging at least 6 months after stroke, with cognitive function sufficient to understand experiments and follow instructions; FMA of 7 to 58 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow and wrist) Exclusion criteria: Botox treatment within 6 weeks of enrolment, fixed contraction of the affected limb, complete flaccid paralysis of the affected limb, history of haemorrhagic stroke, ongoing use of CNS active or psychoactive medications, presence of additional potential tDCS/TMS risk factors, including damaged skin at the site of stimulation, presence of a magnetically/mechanically active implant, metal in the head, family history of epilepsy and personal history of seizures
Interventions	Experimental arm: tDCS + robotic arm therapy, 2 mA for 20 minutes over M1 in the lesioned hemisphere, followed by robotic arm therapy for 60 minutes, 3 times per week for 12 weeks Placebo comparator arm: sham tDCS + robotic arm therapy (0 mA) for 20 minutes over M1 in the lesioned hemisphere, followed by robotic arm therapy for 60 minutes, 3 times per week for 12 weeks
Outcomes	Primary outcome measures: change from baseline in UE‐FM at the end of the intervention period and at 6 months of follow‐up Secondary outcome measures: change from baseline in kinematic data (upper extremity mobility as measured by Interactive Motion Technologies planar (shoulder/elbow) robot and wrist (wrist flexion/extension and pronation/supination) robots during therapy and evaluations) at the end of the intervention period and at 6 months of follow‐up; change from baseline in WMFT at the end of the intervention period and at 6 months of follow‐up; change from baseline Motor Power Manual Muscle Test at the end of the intervention period and at 6 months of follow‐up; change from baseline NIH stroke scale at the end of the intervention period and at 6 months of follow‐up; change from baseline SIS at the end of the intervention period and at 6 months of follow‐up
Starting date	September 2012
Contact information	Bruce T Volpe, MD, bvolpe1@nshs.edu Johanna Chang, MS, jchang14@nshs.edu
Notes