Abstract
BackgroundTraditional treatment for motor impairment after stroke includes medication and physical rehabilitation. The transcranial direct current stimulation associated with a standard physical therapy program may be an effective therapeutic alternative for these patients.MethodsThis study is a sham-controlled, double-blind, randomized clinical trial aiming to evaluate the efficacy of transcranial direct current stimulation in activities of daily living and motor function post subacute stroke. In total there will be 40 patients enrolled, diagnosed with subacute, ischemic, unilateral, non-recurring stroke. Participants will be randomized to two groups, one with active stimulation and the other with a placebo current. Patients and investigators will be blinded. Everyone will receive systematic physical therapy, based on constraint-induced movement therapy. The intervention will be applied for 10 consecutive days. Patients will undergo three functional assessments: at baseline, week 2, and week 4. Neuropsychological tests will be performed at baseline and week 4. Adverse effects will be computed at each session. On completion of the baseline measures, randomization will be conducted using random permuted blocks. The randomization will be concealed until group allocation.DiscussionThis study will investigate the combined effects of transcranial direct current stimulation and physical therapy on functional improvement after stroke. We tested whether the combination of these treatments is more effective than physical therapy alone when administered in the early stages after stroke.Trial registrationNCT02156635 - May 30, 2014. Randomization is ongoing (40 participants randomized as of the end of December 2015).
Highlights
Traditional treatment for motor impairment after stroke includes medication and physical rehabilitation
The present work is a placebo-controlled, double-blind, randomized clinical trial developed to analyze the effectiveness of transcranial direct current stimulation (tDCS) in activities of daily living of stroke patients
The majority of clinical trials involving neuromodulation and rehabilitation involve samples of 20 to 30 subjects and follow-up conducted for approximately three months [17, 100]
Summary
Traditional treatment for motor impairment after stroke includes medication and physical rehabilitation. The transcranial direct current stimulation associated with a standard physical therapy program may be an effective therapeutic alternative for these patients. A stroke is defined as an acute neurological dysfunction of vascular origin, with sudden development of clinical signs of brain function disorders, lasting more than 24 h [1]. In this sense, new therapeutic modalities have been developed for monitoring patients after a stroke [2]. Simis et al [3] conducted a placebo-controlled clinical trial and found that transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) can cause increased hand motor function compared to placebo stimulation. The effects are polarity-dependent, leading to an increase or a decrease
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