[Preprint] Feasibility of Simultaneous Transcranial Direct Current Stimulation During Gait Training in Chronic Stroke Patients: A Randomized Double-blind Pilot Clinical Trial

Abstract

Background
Transcranial direct current stimulation (tDCS) is a therapeutic tool for improving post-stroke gait
disturbances, with ongoing research focusing on specific protocols for its application. We evaluated the
feasibility of a rehabilitation protocol that combines tDCS with conventional gait training.

Methods
This was a randomized, double-blind, single-center pilot clinical trial. Patients with unilateral hemiplegia
due to ischemic stroke were randomly assigned to either the tDCS with gait training group or the sham
stimulation group. The anodal tDCS electrode was placed on the tibialis anterior area of the precentral
gyrus while gait training proceeded. Interventions were administered 3 times weekly for 4 weeks.
Outcome assessments, using the 10-meter walk test, Timed Up and Go test, Berg Balance Scale,
Functional Ambulatory Scale, Modified Barthel Index, and EQ-5D-3L, were conducted before and after the
intervention and again at the 8-week mark following its completion. Repeated-measures ANOVA was used for comparisons between and within groups.

Results
Twenty-six patients were assessed for eligibility, and 20 were enrolled and randomized. No significant
differences were observed between the tDCS with gait training group and the sham stimulation group in
gait speed after the intervention. However, the tDCS with gait training group showed significant
improvement in balance performance in both within-group and between-group comparisons. In the
subgroup analysis of patients with elicited motor-evoked potentials, comfortable pace gait speed
improved in the tDCS with gait training group. No serious adverse events occurred throughout the study.

Conclusions
Simultaneous tDCS during gait training is a feasible rehabilitation protocol for chronic stroke patients
with gait disturbances.

Introduction
Impairment of independent gait is one of the most disabling consequences after a stroke [1]. Gait
abnormality in stroke patients arises from a complex interplay of factors, including lower limb motor
weakness and decreased balance. Some individuals may not be entirely incapable of walking, but they
may still require gait aids or assistance from caregivers. Gait disturbances pose a greater risk of further
injury due to falls. It is well known that fall-associated fractures result in significant socioeconomic costs
[2]. Additionally, gait disturbances lead to limitations in social activity, thereby reducing the quality of life
of stroke patients. Therefore, improving gait performance in stroke patients has long been a desire shared
by patients and physicians.
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that aims to
modulate the human brain by delivering low-intensity electrical current through the scalp. The mechanism of tDCS is explained by 2 principles: (1) the enhancement of cortical activity through a polarity shift in the resting membrane potential and (2) the upregulation of neural plasticity through long-term potentiation [3]. Applying anodal tDCS to patients with subacute stroke has been associated with beneficial effects on motor function [4]. However, inconsistent results have emerged across studies, with some failing to observe significant improvements in patients who underwent tDCS compared to sham stimulation [5].
Additionally, there has been substantial variability in factors, such as stimulation area, intensity, duration,
and the number of sessions among different tDCS protocols, highlighting the need for further research to
establish an optimal tDCS protocol for maximizing the effect of conventional gait training methods.
Studies focusing on stimulation timing suggest that combining tDCS with gait training simultaneously
shows more promising results in improving gait performance compared to protocols that administer gait
training and tDCS separately [6].
This study aimed to evaluate the feasibility of a rehabilitation protocol that combines simultaneous tDCS
with conventional gait training and to investigate its impact on gait performance in chronic stroke
patients.[…]

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