NCT01644929.

Trial name or title	Rehabilitation combined with bihemispheric transcranial direct current stimulation in subacute ischemic stroke to increase upper limb motor recovery: a randomised, controlled, double‐blind study (RECOMBINE)
Methods	Double‐blind randomised controlled cross‐over trial (multicentre)
Participants	36 people 18 years of age or older with subcortical or subcortical/cortical ischaemic lesions in the territory of MCA, as confirmed by neuroimaging in the subacute phase (2 to 4 weeks after stroke) with persistent hemiparesis (score of 1 to 3 on the motor arm item of the NIH Stroke Scale (NIHSS) but wrist and finger movement is not required) and no upper extremity injury or conditions that limited its use before the stroke; subscription of informed consent Exclusion criteria: history of epilepsy, brain tumour, major head trauma, learning disorder, severe cognitive impairment, drug or alcohol abuse, major psychiatric illness. Use of medications that may lower seizure threshold (e.g. metronidazole, fluoroquinolones), severe pain in the affected upper limb (≥ 8 on the shoulder item of the "joint pain during passive motion" of the UE‐FM); recurrent stroke or other significant medical complications during the study; evidence of severe leucoencephalopathy (grade IV according to Fazeka's scale); significant aphasia that would impair understanding and performance on assessment scales
Interventions	Each participant receives standardised physical/occupational treatment according to the Impairment‐Oriented Training, plus 1 of the following treatment schemes: Experimental 1: A‐tDCS of the ipsilesional motor cortex and C‐tDCS of the contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during 3 weeks, then sham stimulation for 30 seconds on 15 days during 3 weeks Experimental 2: sham tDCS for 30 seconds on 15 days during 3 weeks, then A‐tDCS of the ipsilesional motor cortex and C‐tDCS of the contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during 3 weeks Sham comparator: treatment for 6 weeks daily with sham tDCS for 30 seconds on 15 days during 6 weeks
Outcomes	Primary outcome measures: UE‐FM at the end of the intervention period Secondary outcome measures: UE‐FM at 3 weeks and at 6 months; BI at 3 weeks, at 6 weeks and at 6 months; Ashworth scale at 3 weeks, at 6 weeks and at 6 months; Test of Upper Limb Apraxia (TULIA) at 6 weeks and at 6 months; grip strength at 3 weeks, at 6 weeks and at 6 months; Hamilton Depression Rating Scale at 6 weeks and at 6 months
Starting date	September 2012
Contact information	Carlo Cereda, MD, Carlo.Cereda@eoc.ch René Müri, MD, rene.mueri@insel.ch
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