NCT05289115

Protocol for Assistance to Patients With Long Covid-19 Undergoing Treatment With HD-tDCS

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Federal University of Paraíba · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

COVID-19 is an infectious disease which presents a heterogenous clinical presentation. Recent investigations suggest that people who were infected by COVID-19 often develop physical disabilities (i.e. pain, fatigue) and neurological complications after hospital discharge. Many therapeutic approaches such as transcranial direct current stimulation high definition (HD-tDCS) have been proposed to minimize functional and structural impairments. Recently, I electroencephalogram (EEG) has been used as predictor of HD-tDCS effectiveness in diverse neurological populations. However, evidences about this tool utilization 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 of patients with COVID-19 chronic.

Detailed description

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).

Conditions

• Coronavirus
• COVID-19 Respiratory Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-14
• Primary completion: 2022-04-14
• Completion: 2022-07-14
• First posted: 2022-03-21
• Last updated: 2022-03-21

Locations

1 site across 1 country: Brazil