EFFECTS OF HIGH DEFINITION TRANSCRANIAL CONTINUOUS CURRENT STIMULATION (HD-TDCS) ON THE MUSCLE ACTIVITY OF UPPER LIMBS OF PATIENTS WITH IT: DOUBLE BLIND PARALLEL RANDOMIZED CLINICAL TRIAL PROTOCOL AND CASE REPORT.
Amyotrophic lateral sclerosis; IN G; TDCS; Wearable Electronic Devices.
INTRODUCTION: Amyotrophic Lateral Sclerosis (ALS) is an acquired, neurodegenerative and disabling disease of the nervous system, causing motor and extra-motor symptoms. It is characterized by a functional decline in affected patients, which culminates in a definitive inability to carry out activities of daily living, dysphagia and respiratory failure. In ALS, studies related to tDCS present consolidated results on the hypothesis of hyperexcitability in the neural corticomotor system, with some interesting aspects in its mechanisms of action that could minimize this hyperexcitability. According to the assembly in target areas, tDCS' main action is to act on the resting membrane potential and produce a prolonged suppression of neuronal excitability. This effect is determined by the modulation of dependent synaptic plasticity, which induces a return of the cell to its physiological conditions. The main objective of this study is to evaluate the effects of a High Definition Transcranial Direct Current Stimulation (HD-tDCS) protocol on the motor performance of the upper limbs of patients with ALS.METHODOLOGY: This is a randomized controlled clinical trial protocol, parallel, double-blind clinical trial with 2 arms, 1:1 allocation, following the recommendations of the Consolidated Standards of Reporting Trials (CONSORT), carried out based on this clinical trial protocol, based in the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT). Subjects diagnosed with ALS will be included according to the revised El Escorial criteria, aged between 18 and 80 years, good cognitive level on the ALS Cognitive Behavioral Screen scale (≥17 points), able to understand and execute simple motor actions from verbal commands. Participants will be evaluated at the Neuromuscular Diseases Outpatient Clinic of the Onofre Lopes University Hospital (HUOL). The experimental group will carry out an initial assessment, and if it meets the inclusion criteria, it will undergo five HD-TDCS sessions on consecutive days (one session on each day), which will last 20 minutes and have an intensity of 3mA. Subsequently, the Sham group will receive simulations of the application of high-definition tDCS, with the device providing a period of acceleration of 30 s until the full 3 mA, immediately followed by a reduction of 30 s. The same initial evaluator will reevaluate the participants after completing the five sessions and a follow-up evaluation will take place one week later. The primary outcome will be the analysis of muscle electrical activity using surface electromyography. As secondary outcomes, pain (numeric visual scale) and muscle fatigue (fatigue severity scale) will be considered. Appropriate statistical tests will be used for distribution analysis (Chi-square or Fisher's exact test), analysis of normality and homogeneity of data variance (Shapiro-Wilk and Levene tests) and comparison between groups through two-way ANOVA with analyzes post-hoc (Bonferroni) if necessary. Significance will be set at 5%.