Transcranial direct current stimulation (tDCS) for neurological disability among subacute stroke survivors to improve multiple domains in health-related quality of life: Randomized controlled trial protocol

Objectives: The primary goal of the current proposal is to fill the gaps in the literature by studying the effectiveness of transcranial direct current stimulation (tDCS) on lifestyle parameters, and physical, behavioral, and cognitive functions among stroke survivors, and understanding the factors that mediate the effects of various domains related to Health-related Quality of life (HRQoL) improvements. Methods: Anticipated 64 volunteer subacute stroke survivors (>7 days to 3 months post stroke) aged 40–75 years with National Institutes of Health stroke scale (NIHSS) score of >10 and Mini-Mental State Examination (MMSE) score between 18 and 23 will be randomly assigned at a ratio of 1:1 to receive either: (1) 20 sessions of anodal tDCS or (2) sham tDCS in addition to conventional rehabilitation. Battery driven tDCS will be applied at 2 mA intensity to the dorsolateral prefrontal cortex and primary motor cortex for 20 minutes. The primary endpoints of study will be 36-Item Short Form Survey (SF-36) post intervention at 4 weeks. The secondary outcomes will include Stroke Specific Quality of Life Scale (SS_QOL), Montreal cognitive assessment (MCA), Beck Anxiety Inventory (BAI), Fugl-Meyer Assessment (FMA), 10 m walk test and Modified Barthel Activities of daily living (ADL) Index. At 0.05 level of significance, data normality, within group and between group actual differences will be analyzed with a moderate scope software. Discussion: Our knowledge of this technique and its use is expanding daily as tDCS motor recovery studies—mostly single-center studies—in either single session or many sessions have been completed and shown positive results. The field is prepared for a multi-center, carefully planned, sham-controlled, double-blinded tDCS study to comprehensively examine its feasibility and effectiveness in enhancing outcomes in stroke population. Conclusion: The function of Transcranial Direct Current Stimulation in aiding stroke recuperation will be ascertained.