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

Primary Purpose

Coronavirus, COVID-19 Respiratory Infection

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Experimental group/ Active HD-tDCS
Control Group / Sham Group
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus focused on measuring COVID-19 Respiratory Infection, Transcranial direct current stimulation, Non-invasive brain stimulation, Electroencephalography, Long Covid

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
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.

Sites / Locations

  • Federal University of Paraíba,Department of PsychologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental Group/ Active HD-tDCS

Control Group / Sham Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Fatigue Impact
MFIS-BR is a tool composed by 21 items stratified into 3 domains

Secondary Outcome Measures

Pain Level
Pain level will be evaluated through McGill questionnaire.
Functional Capacity
Functional capacity will be evaluated by Lawton and Brody scale and also by 6 minutes walking test.
Quality of Life
Quality of life will be measured through Brazilian version of World Health Organization Quality of Life.
Pulmonary Function
This outcome will be assessed through spirometry, assessment of maximal inspiratory pressure and respiratory endurance.
Body Composition
Body composition analysis will be carried out by bioelectrical impedance analysis.
Anxiety
Anxiety level will be evaluated through Hamilton Anxiety Rating Scale.
Depression
Depression will be assessed by Beck's Depression Inventory.
Self-efficacy
Self-efficacy will be evaluated through the Self-efficacy manage chronic disease 6-item scale.

Full Information

First Posted
March 16, 2022
Last Updated
March 18, 2022
Sponsor
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT05289115
Brief Title
Protocol for Assistance to Patients With Long Covid-19 Undergoing Treatment With HD-tDCS
Official Title
Protocol for Assistance to Patients With Long Covid-19 Undergoing Treatment With HD-tDCS
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
April 14, 2022 (Anticipated)
Study Completion Date
July 14, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus, COVID-19 Respiratory Infection
Keywords
COVID-19 Respiratory Infection, Transcranial direct current stimulation, Non-invasive brain stimulation, Electroencephalography, Long Covid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suellen Andrade, Phd
Phone
986046032
Ext
5583
Email
suellenandrade@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Santana
Phone
910403928
Ext
5511
Email
kjs.fisio@gmail.com
Facility Information:
Facility Name
Federal University of Paraíba,Department of Psychology
City
João Pessoa
State/Province
Paraiba
ZIP/Postal Code
58051-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suellen Andrade, Phd
Phone
986046032
Ext
5583
Email
suellenadrade@gmail.com
First Name & Middle Initial & Last Name & Degree
Kelly Santana
Phone
910403928
Ext
5511
Email
kjs.fisio@gmail.com

12. IPD Sharing Statement

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

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