Effects of Transcranial Direct Current Stimulation (tDCS) dosage optimization and response prediction analysis in patients with amnestic Mild Cognitive Impairment (MCI): a randomized, triple-blind, sham-controlled clinical trial.

https://docs.google.com/spreadsheets/d/1oc3eSH0QqRbuxBIcVd-KuaWYo4VwlckE/edit#gid=2095656188

Transcranial Direct Current Stimulation is a non-invasive neuromodulatory technique that has shown results in the clinical improvement of patients with Mild Cognitive Impairment, a prodromal condition for the onset of dementia. The responses to the treatment depend on the characteristics of the patients and the parameters adjusted in the equipment, which makes the modeling of the electric fields imperative to maximize the safety profile and the therapeutic potential of the technique. The study of neurobiological predictors of response to non-invasive neurostimulation and genetic susceptibility can elucidate the effects of current according to the individual's profile. The objectives are: To observe the effects of Transcranial Direct Current Stimulation with optimized/personalized parameters in patients with amnestic MCI, considering the genetic susceptibility of subjects to Alzheimer's Disease and brain electrical activity as predictors of response. This is a randomized, triple-blind, sham-controlled clinical trial (ClinicalTrials.org: NCT04943003). Neuropsychological tests and a sociodemographic and clinical questionnaire will be used to assess and characterize the subjects. The participants captured by the Laboratory of Studies in Aging and Neurosciences of the Federal University of Paraíba will be divided into 02 groups, each with 25 patients, totaling 50 volunteers: Active – participants who will receive real anodic current; Sham – participants who will receive simulated stimulation. Participants entered through the eligibility criteria will be randomly allocated in a simple way, at a ratio of 1:1. The equipment parameters will be customized by Computational Modeling with the help of the Simulation of Non-invasive Brain Stimulation Program and the measurement of the head circumference. The electroencephalogram and the evaluation of polymorphisms of the gene encoding Apolipoprotein E will be considered as predictors of response. Data will be processed using the Software Statistical Package for the Social Sciences® (20.0), applying Student's t test for continuous variables or chi-square test for categorical variables. The prediction analysis will be conducted using Machine Learning. The project was evaluated by the Research Ethics Committee of the Federal University of Paraíba, obtaining the following CAAE registration: 46072621.8.0000.5188. It is expected to find improvements in the scores of general cognition and memory tests after the intervention protocol of neurostimulation with an individualized dose in the group that will receive the active current, compared to the sham neurostimulation group. These results may optimize clinical practice, elucidating questions that are still present due to the different applications of the technique.