Effect of Transcranial Direct Current Stimulation associated with aerobic exercise on the autonomic modulation of hemiparetic individuals due to stroke: a study protocol for a double-blind randomized controlled trial

Abstract

Background: Individuals after a stroke have an imbalance in the autonomic nervous system, which increases the risk of death or recurrent episodes of stroke. Transcranial Direct Current Stimulation (tDCS) combined with aerobic exercise has shown an effect on the modulation of this system. Objective: The Heart Rate Variability (HRV) and the distance traveled on the exercise bike will be assessed to verify the additional impact of tDCS combined with aerobic exercise on individuals with chronic stroke sequelae. Methods: The 34 adult individuals with diagnoses of chronic stroke will be randomized into two aerobic exercise intervention groups: G1 (with active tDCS) and G2 (with sham tDCS), three times a week, for 12 weeks. Procedures: tDCS will be implemented during the aerobic exercise with the anodal electrode positioned over the lateral dorsal prefrontal left cortex, and the cathodal electrode over the contralateral supraorbital region, with 2mA, for 20 minutes. Assessments will be carried out pre, immediately after the intervention, and on the 12th, 24th, 36th interventions, and 30 days later. The HRV data that are pulse interval (PI), square root of the mean of the squares of the differences between adjacent normal RR intervals (rMSSD), absolute high frequency (HF), absolute low frequency (LF), high and low frequency ratio (LF / HF) will be collected using a cardio frequency meter. The analysis of the distance traveled on the exercise bike before and after interventions will be analyzed in meters. Discussion: The autonomic control via brain networks after a stroke can be altered and can promote an increase in sympathetic tone, and a higher risk of sudden death or relapse of stroke.  It is crucial to demonstrate the effectiveness of available treatments to improve the autonomic function. Trial registration: The study is registered as a BRAZILIAN CLINICAL TEST RECORD (ReBEC): U1111-1222-4588 on the 2018/10/16