Efficacy of Anodal Transcranial Direct Current Stimulation Combined With Conventional Physiotherapy in Sub-Acute Stroke: A Randomized, Triple-Blind, Sham-Controlled Trial
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Abstract
Background: Transcranial Direct Current Stimulation (tDCS) modulates cortical excitability and may augment neurorehabilitation after stroke, but clinical gains in the sub-acute window remain uncertain due to heterogeneous results and protocol variability. This trial examined whether adding anodal tDCS over ipsilesional M1 to intensive physiotherapy improves motor, somatosensory, and participation outcomes versus sham in sub-acute stroke.
Methods: Adults 18–80 years with first-ever ischemic stroke in the sub-acute stage were randomized 1:1 to active anodal tDCS (1 mA, 20 minutes, 5 sessions/week for 4 weeks; anode over lesioned M1; cathode contralesional supraorbital) or sham, starting 48 h post-onset, alongside standardized physiotherapy and occupational therapy (2 h/day, 5 days/week). Outcomes were assessed at 48 h, weekly to 4 weeks, and at 3 months, 6 months, and 1 year: Wolf Motor Function Test (WMFT), Fugl-Meyer Upper/Lower Extremity (UEFM/LEFM), Fugl-Meyer Somatosensory subscale, Semmes-Weinstein Monofilament Test (SWMT), Tardieu, Stroke Impact Scale (SIS), Hospital Anxiety and Depression Scale (HADS), and Barthel Index. Primary analysis used two-way repeated-measures ANOVA (time × treatment), intention-to-treat, normality via Shapiro–Wilk, effect sizes via Cohen’s d.
Results: The active tDCS group showed greater improvements over time in WMFT time and score, UEFM, and SIS domains compared to sham, with small-to-moderate effect sizes, while LEFM and somatosensory measures (SWMT, Fugl-Meyer Sensory) showed favorable but variable gains; adherence and blinding were high. Adverse events were mild and transient (tingling, itching), comparable to sham.
Conclusions: Anodal tDCS over ipsilesional M1 combined with conventional physiotherapy produced clinically meaningful motor and participation benefits versus sham in sub-acute stroke, with acceptable safety, supporting tDCS as an adjunct to early task-specific rehabilitation. Variability across sensory outcomes and known inter-individual response differences underscore the need for protocol standardization and personalization.
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References
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