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

NCT05289115 | Unknown

• 1 other identifier: LongCOVID/HD-tDCS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus; COVID-19 Respiratory Infection

Keywords

COVID-19 Respiratory Infection; Transcranial direct current stimulation; Non-invasive brain stimulation; Electroencephalography; Long Covid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pain Level

  From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)

• Functional Capacity

  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

  From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)

• Pulmonary Function

  From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)

• Body Composition

  From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)

Study Arms (2)

Experimental Group/ Active HD-tDCS

EXPERIMENTAL

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.

Device: Experimental group/ Active HD-tDCS

Control Group / Sham Group

SHAM COMPARATOR

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.

Device: Control Group / Sham Group

Interventions

Experimental group/ Active HD-tDCS DEVICE

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.

Experimental Group/ Active HD-tDCS

Control Group / Sham Group DEVICE

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.

Control Group / Sham Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Federal University of Paraíba,Department of Psychology

João Pessoa, Paraíba, 58051-900, Brazil

RECRUITING

MeSH Terms

Conditions

Coronavirus Infections; Post-Acute COVID-19 Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Suellen Andrade, Phd

CONTACT

986046032; suellenandrade@gmail.com

Kelly Santana

CONTACT

910403928; kjs.fisio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 21, 2022
• Study Start: September 14, 2021
• Primary Completion: April 14, 2022
• Study Completion: July 14, 2022
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

BR (1)