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

Abstract

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.