Patient-Tailored Transcranial Direct Current Stimulation Versus Sham for Upper-Extremity Rehabilitation in Subacute Stroke Patients: A Feasibility and Pilot Trial

Background: Stroke is a leading cause of upper-extremity (UE) motor impairments worldwide. Transcranial direct current stimulation (TDCS) may enhance UE recovery, but response variability remains a challenge. Objective: This randomized, double-blinded feasibility and pilot clinical trial evaluated effects of patient-tailored TDCS versus sham on UE recovery in subacute stroke. Methods: Patients with subacute ischemic stroke and UE impairment were randomized to receive either anodal TDCS or sham stimulation, during UE rehabilitation 3 times weekly for 4 weeks. Electrode placement was patient-tailored and optimized using electric field modeling and targeted the ipsilesional primary motor hand area (M1-HAND). Primary outcome was Fugl-Meyer Assessment of UE (FMA-UE) score at end-of-intervention (EOT) and 12-weeks follow-up. Feasibility and exploratory clinical outcomes were also assessed. Results: 24 participants were randomized into real (n = 12, mean age 63 years) and sham TDCS (n = 12, mean age 68 years). FMA-UE improved at EOT in both groups, but improvement was significantly larger in the real TDCS group (mean difference 4.5 points, 95% confidence interval (CI) −5.34-14.31, P = .011). The differences diminished at 12-week follow-up. Median compliance was 95.8 and 100%, for real- and sham-TDCS groups, respectively, with no severe adverse events. Conclusions: Patient-tailored anodal TDCS over the ipsilesional M1-HAND may boost recovery of UE impairment in subacute stroke versus sham TDCS. This trial identified a clinically feasible framework for optimizing protocols of patient-tailored TDCS for larger-scale stroke trials. Despite the complex trial setup, the favorable safety profile supports future large-scale studies with improved stratification by UE impairment.