We conducted a double-blind, randomized, sham-controlled study to investigate the efficacy and safety of bihemispheric tDCS for motor recovery in subacute stroke patients. The ethics committee approved the study at the Taipei Veterans General Hospital (VGHIRB No. 2015-03-003C) and registered with ClinicalTrials.gov (NCT02731508). We screened 282 consecutive inpatients between September 2015 and June 2021 and validated their eligibility for the following inclusion criteria (Fig. 1 ): (1) age between 20 and 80 years; (2) acute first-ever unilateral infarction confirmed by diffusion-weighted MRI; (3) consciousness clear and able to sign the informed consent form. The exclusion criteria were: (1) sensorimotor cortical infarcts; (2) too mild or too severe FMA-UE scores, i.e. > 56 or < 2 (0–66, where 0 is no function and 66 is maximum) [38 (link)]; (3) sensory or motor aphasia; (4) severe medical diseases (advanced malignancy, end-stage heart, liver or kidney failure, etc.) with premorbid modified Rankin Scale (mRS) > 1; (5) major neuropsychiatric diseases (dementia, epilepsy, parkinsonism, cerebellar ataxia, major depression, etc.); (6) contraindications to transcranial magnetic stimulation (TMS) for increased risk (presence of metallic implants, pregnancy); and (7) participating in other interventional studies.![]()
Enrollment flowchart of this randomized controlled trial. FMA-UE, Fugl-Meyer Assessment of Upper Extremity; tDCS, transcranial direct current stimulation
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