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

Coronavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05289115
• Other study ID #: LongCOVID/HD-tDCS
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: July 14, 2022

Study information

• Verified date: March 2022
• Source: Federal University of Paraíba
• Contact: Suellen Andrade, Phd
• Phone: 986046032
• Email: suellenandrade[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 14, 2022
• Est. primary completion date: April 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus
• COVID-19
• Respiratory Tract Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Paraíba,Department of Psychology	João Pessoa	Paraiba

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Impact	MFIS-BR is a tool composed by 21 items stratified into 3 domains	From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
Secondary	Pain Level	Pain level will be evaluated through McGill questionnaire.	From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
Secondary	Functional Capacity	Functional capacity will be evaluated by Lawton and Brody scale and also by 6 minutes walking test.	From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
Secondary	Quality of Life	Quality of life will be measured through Brazilian version of World Health Organization 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)
Secondary	Pulmonary Function	This outcome will be assessed through spirometry, assessment of maximal inspiratory pressure and respiratory endurance.	From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
Secondary	Body Composition	Body composition analysis will be carried out by bioelectrical impedance analysis.	From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
Secondary	Anxiety	Anxiety level will be evaluated through Hamilton Anxiety Rating Scale.	From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
Secondary	Depression	Depression will be assessed by Beck's Depression Inventory.	From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
Secondary	Self-efficacy	Self-efficacy will be evaluated through the Self-efficacy manage chronic disease 6-item scale.	Self-efficacy will be assessed after intervention ending.