COVID-19 is an infectious disease which presents a heterogenous clinical presentation.Recent investigations suggest that people who were infected by COVID-19 often developphysical disabilities (i.e. pain, fatigue) and neurological complications after hospitaldischarge. Many therapeutic approaches such as transcranial direct current stimulationhigh definition (HD-tDCS) have been proposed to minimize functional and structuralimpairments. Recently, I electroencephalogram (EEG) has been used as predictor of HD-tDCSeffectiveness in diverse neurological populations. However, evidences about this toolutilization as efficacy predictor of tDCS in COVID-19 people rest inconclusive. Thereby,our objective is to evaluate HD-tDCS efficacy on fatigue, pain and functional capacity ofpatients with COVID-19 chronic.
We propose a sham-controlled randomized clinical trial with patients in COVID-19 chronic.
They will be evaluated according to following eligibility criteria :
Patients who had a medical diagnosis of COVID-19, clinically stable, able to respond to
simple commands, able to walk for six minutes and who sign study consent form will be
enrolled. Those who present associated neurological diseases, pregnant, users of
psychoactive drugs, patients who have metallic implants, electronic devices, pacemakers,
or epileptic patients will be excluded.
Patients will be allocated randomly to the experimental group or sham control. Sessions
for experimental group consist of anodal HD-tDCS on Left diaphragmatic primary motor
cortex associated to respiratory training (10 sessions, 3mA, 20 minutes/session). In the
sham condition, the device provided a 30-second ramp-up period to the full 3 mA, followed
immediately by a 30-second ramp down.
Patients will be assessed in three moments: pre-treatment, post-treatment and after 30
days treatment ending (follow-up).
Device: Experimental group/ Active HD-tDCS
Patients enrolled in this group will received 20 minutes of anodal HD-tDCS ( tDCS 1x1,
developed by Soterix Medical Inc.) during 10 sessions. It will be delivered a 3mA
intensity electrical current accordingly 10/20 International System on cortical
representation zone of left diaphragmatic motor cortex using HD-tDCS.
Device: Control Group / Sham Group
10-sessions of anodal HD-tDCS( tDCS 1x1, developed by Soterix Medical Inc.) associated to
respiratory training; for 20 minutes (each session) with a 3mA intensity.The device will
provide a 30-second ramp-up followed immediately by a 30-second ramp down.
Patients who had a medical diagnosis of COVID-19, clinically stable, able to respond to
simple commands, able to walk for six minutes and who sign study consent form will be
enrolled. Those who present associated neurological diseases, pregnant, users of
psychoactive drugs, patients who have metallic implants, electronic devices, pacemakers,
or epileptic patients will be excluded.
Federal University of Paraíba,Department of Psychology
João Pessoa, Paraiba, Brazil
Investigator: Suellen Andrade, Phd
Contact: 986046032
suellenadrade@gmail.com
Suellen Andrade, Phd
986046032 - 5583
suellenandrade@gmail.com
Kelly Santana
910403928 - 5511
kjs.fisio@gmail.com
Not Provided