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

Not Applicable

• Conditions: Respiratory Infection; Coronavirus COVID-19

• Registration Number: NCT05289128
• 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 (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).

Study Timeline

• Study Start: 2022-02-07
• 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: 2022-06-25
• Study Completion: 2022-07-31

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

Primary Outcome Measures

Name	Time	Method
Responders and non-responders to treatment with HD-tDCS	From date of randomization up to 5 weeks	Identification of responders and non-responders according to the scores fatigue measured using MFIS-BR.

Secondary Outcome Measures

Name	Time	Method
Neurophysiological characteristics and biomarkers recorded by EEG	Assessed one week before intervention beginning (T0);	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	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 considering pain multifactorial characteristics.
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 evaluate through Hamilton Anxiety Rating Scale which measures the severity of anxiety symptoms.
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.
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.
Self-efficacy	From date of randomization (1 week before intervention begining) up to 5 weeks (T1)	Self-efficacy will be evalluated through the Self-efficacy manage chronic disease 6-item scale.
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.
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.

Trial Locations

Locations (1)

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