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

Not Applicable

• Conditions: Coronavirus; COVID-19 Respiratory Infection
• Interventions: Device: Control Group / Sham Group; Device: Experimental group/ Active HD-tDCS

• Registration Number: NCT05289115
• Lead Sponsor: Federal University of Paraíba

Brief 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).

Study Timeline

• Study Start: 2021-09-14
• Status Verified: 2022-03
• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-18
• Last Update Submitted: 2022-03-18
• Study First Posted: 2022-03-21
• Last Update Posted: 2022-03-21
• Primary Completion: 2022-04-14
• Study Completion: 2022-07-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group / Sham Group	Control Group / Sham Group	Patients enrolled in this group condition will receive 10 sessions of anodal stimulation on cortical representation zone of left diaphragmatic motor cortex using HD-tDCS associated to respiratory training; for 20 minutes (each session) with a 3mA intensity. In the sham condition, the device will provide a 30-second ramp-up followed immediately by a 30-second ramp down.
Experimental Group/ Active HD-tDCS	Experimental group/ Active HD-tDCS	Patients who will be randomly enrolled in this group. They will receive 10 sessions of anodal stimulation on cortical representation zone of left diaphragmatic motor cortex using HD-tDCS associated to respiratory training; for 20 minutes (each session) with a 3mA intensity. The electrical current will be delivered with a ramp-up time of 30 s, held at 3mA for 20 min, and then ramped down over 30 s.

Primary Outcome Measures

Name	Time	Method
Fatigue Impact	From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)	MFIS-BR is a tool composed by 21 items stratified into 3 domains

Secondary Outcome Measures

Name	Time	Method
Pain Level	From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)	Pain level will be evaluated through McGill questionnaire.
Functional Capacity	From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)	Functional capacity will be evaluated by Lawton and Brody scale and also by 6 minutes walking test.
Body Composition	From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)	Body composition analysis will be carried out by bioelectrical impedance analysis.
Anxiety	From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)	Anxiety level will be evaluated through Hamilton Anxiety Rating Scale.
Quality of Life	From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)	Quality of life will be measured through Brazilian version of World Health Organization Quality of Life.
Pulmonary Function	From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)	This outcome will be assessed through spirometry, assessment of maximal inspiratory pressure and respiratory endurance.
Depression	From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)	Depression will be assessed by Beck's Depression Inventory.
Self-efficacy	Self-efficacy will be assessed after intervention ending.	Self-efficacy will be evaluated through the Self-efficacy manage chronic disease 6-item scale.

Trial Locations

Locations (1)

Federal University of Paraíba,Department of Psychology; 🇧🇷 João Pessoa, Paraiba, Brazil