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EEG as Predictor of HD-tDCS Effectiveness in Long COVID-19

Primary Purpose

Coronavirus COVID-19, Respiratory Infection

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

About this trial

This is an interventional treatment trial for Coronavirus COVID-19 focused on measuring Transcranial direct current stimulation, Non-invasive brain stimulation, Electroencephalography, Machine Learning, COVID-19 Respiratory Infection, 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 randomly enrolled in this group will receive 10 sessions of anodal HD-tDCS stimulation on cortical representation zone of left diaphragmatic motor cortex associated to respiratory training; for 20 minutes (each session) with a 2mA 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 2mA 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

Responders and non-responders to treatment with HD-tDCS
Identification of responders and non-responders according to the scores fatigue measured using MFIS-BR.

Secondary Outcome Measures

Neurophysiological characteristics and biomarkers recorded by EEG
The EEG data will be retrospectively examined by comparing the two groups (responders and non-responders), identifying possible neurophysiological characteristics and biomarkers related to frequency bands and connectivity that could be characterized as possible markers of response to treatment, predicting which ones are most likely to respond.
Pain Level
Pain level will be evaluated through McGill questionnaire considering pain multifactorial characteristics.
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 evaluate through Hamilton Anxiety Rating Scale which measures the severity of anxiety symptoms.
Depression
Depression will be assessed by Beck's Depression Inventory.
Self-efficacy
Self-efficacy will be evalluated 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
NCT05289128
Brief Title
EEG as Predictor of HD-tDCS Effectiveness in Long COVID-19
Official Title
Predicting Outcomes From HD-tDCS Intervention in Long COVID-19 Using Electroencephalographic Biomarkers and Machine Learning Approach.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
June 25, 2022 (Anticipated)
Study Completion Date
July 31, 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
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 (tDCS) have been proposed to minimize functional and structural impairments. Electroencephalogram (EEG) has been used in this population to assess electrophysiological changes in the brain. However, evidences about EEG utilization as efficacy predictor of tDCS in COVID-19 people rest inconclusive.Our objective is to evaluate EEG as neurobiological predictor marker of tDCS efficacy on fatigue, pain, quality of life, self-efficacy and functional capacity in the chronic phase of COVID-19.
Detailed Description
A double-blinded randomized clinical trial will be carried to analyse the EEG as neurobiological predictor marker of HD-tDCS 4x1 in patients in long COVID-19. This study is in accordance with the CONSORT guidelines, which will investigate the effectiveness of treatment with HD-tDCS. 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
Transcranial direct current stimulation, Non-invasive brain stimulation, Electroencephalography, Machine Learning, COVID-19 Respiratory Infection, Long COVID

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Experimental Group/ Active HD-tDCS
Arm Type
Experimental
Arm Description
Patients randomly enrolled in this group will receive 10 sessions of anodal HD-tDCS stimulation on cortical representation zone of left diaphragmatic motor cortex associated to respiratory training; for 20 minutes (each session) with a 2mA 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 2mA 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
Other Intervention Name(s)
Active HD-tDCS
Intervention Description
10-sessions of anodal HD-tDCS ( tDCS 1x1, developed by Soterix Medical Inc.) associated to respiratory training; for 20 minutes (each session). 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)
Sham Control
Other Intervention Name(s)
Control 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
Responders and non-responders to treatment with HD-tDCS
Description
Identification of responders and non-responders according to the scores fatigue measured using MFIS-BR.
Time Frame
From date of randomization up to 5 weeks
Secondary Outcome Measure Information:
Title
Neurophysiological characteristics and biomarkers recorded by EEG
Description
The EEG data will be retrospectively examined by comparing the two groups (responders and non-responders), identifying possible neurophysiological characteristics and biomarkers related to frequency bands and connectivity that could be characterized as possible markers of response to treatment, predicting which ones are most likely to respond.
Time Frame
Assessed one week before intervention beginning (T0);
Title
Pain Level
Description
Pain level will be evaluated through McGill questionnaire considering pain multifactorial characteristics.
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 evaluate through Hamilton Anxiety Rating Scale which measures the severity of anxiety symptoms.
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 evalluated through the Self-efficacy manage chronic disease 6-item scale.
Time Frame
From date of randomization (1 week before intervention begining) up to 5 weeks (T1)

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
Email
suellenandrade@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Santana
Phone
11 910403928
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
Email
suellenadrade@gmail.com
First Name & Middle Initial & Last Name & Degree
Kelly Santana
Phone
11 91040 3928
Email
kjs.fisio@gmail.com

12. IPD Sharing Statement

Learn more about this trial

EEG as Predictor of HD-tDCS Effectiveness in Long COVID-19

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