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 stimulation(tDCS) have been proposed to minimize functional and structural impairments.Electroencephalogram (EEG) has been used in this population to assesselectrophysiological changes in the brain. However, evidences about EEG utilization asefficacy predictor of tDCS in COVID-19 people rest inconclusive.Our objective is toevaluate EEG as neurobiological predictor marker of tDCS efficacy on fatigue, pain,quality of life, self-efficacy and functional capacity in the chronic phase of COVID-19.
A double-blinded randomized clinical trial will be carried to analyse the EEG as
neurobiological predictor marker of HD-tDCS 4x1 in patients in long COVID-19. This study
is in accordance with the CONSORT guidelines, which will investigate the effectiveness of
treatment with HD-tDCS.
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
10-sessions of anodal HD-tDCS ( tDCS 1x1, developed by Soterix Medical Inc.) associated
to respiratory training; for 20 minutes (each session). 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.
Other Name: Active HD-tDCS
Device: Sham Control
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.
Other Name: Control Group
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
suellenandrade@gmail.com
Kelly Santana
11 910403928
kjs.fisio@gmail.com
Not Provided