Abstract
BackgroundFollowing stroke, patients are often left with hemiparesis that reduces balance and gait capacity. A recent, non-invasive technique, transcranial direct current stimulation, can be used to modify cortical excitability when used in an anodal configuration. It also increases the excitability of spinal neuronal circuits involved in movement in healthy subjects. Many studies in patients with stroke have shown that this technique can improve motor, sensory and cognitive function. For example, anodal tDCS has been shown to improve motor performance of the lower limbs in patients with stroke, such as voluntary quadriceps strength, toe-pinch force and reaction time. Nevertheless, studies of motor function have been limited to simple tasks. Surprisingly, the effects of tDCS on the locomotion and balance of patients with chronic stroke have never been evaluated. In this study, we hypothesise that anodal tDCS will improve balance and gait parameters in patients with chronic stroke-related hemiparesis through its effects at cortical and spinal level.Methods/designThis is a prospective, randomised, placebo-controlled, double-blinded, single-centre, cross-over study over 36 months. Forty patients with chronic stroke will be included. Each patient will participate in three visits: an inclusion visit, and two visits during which they will all undergo either one 30-min session of transcranial direct current stimulation or one 30-min session of placebo stimulation in a randomised order. Evaluations will be carried out before, during and twice after stimulation. The primary outcome is the variability of the displacement of the centre of mass during gait and a static-balance task. Secondary outcomes include clinical and functional measures before and after stimulation. A three-dimensional gait analysis, and evaluation of static balance on a force platform will be also conducted before, during and after stimulation.DiscussionThese results should constitute a useful database to determine the aspects of complex motor function that are the most improved by transcranial direct current stimulation in patients with hemiparesis. It is the first essential step towards validating this technique as a treatment, coupled with task-oriented training.Trial registrationClinicalTrials.gov, ID: NCT02134158. First received on 18 December 2013; last updated on 14 September 2016. Other study ID numbers: P120135 / AOM12126, 2013-A00952-43.
Highlights
Following stroke, patients are often left with hemiparesis that reduces balance and gait capacity
These results should constitute a useful database to determine the aspects of complex motor function that are the most improved by transcranial direct current stimulation in patients with hemiparesis
This study should demonstrate that anodal Transcranial direct current stimulation (tDCS) improves kinematic and kinetic gait parameters, and performance on functional tests, and reduces the clinical symptoms of stroke
Summary
Impact Comparison of the effects of anodal and placebo tDCS on the different motor functions should demonstrate that anodal tDCS significantly improves gait and balance in chronic stroke by reducing the variability of the COM during gait, static and static-dynamic balance tasks. If no robust explanation is found, this would suggest that anodal tDCS has no effect on gait and balance In this case, further studies should investigate other stimulation conditions (bilateral stimulation, stimulation of another cortical zone of or repeated stimulations sessions). Andrade et al (2017) showed that 10 sessions of tDCS can reduce the risk of falls in patients with chronic stroke [62] Despite these positive results, many questions remain unanswered [63]. Trial status The trial is ongoing at the time of manuscript submission
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