Clinical trial NCT05289128: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Coronavirus COVID-19
Respiratory Infection
Keywords: Transcranial direct current stimulation
Non-invasive brain stimulation
Electroencephalography
Machine Learning
COVID-19 Respiratory Infection
Long COVID
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Responders and non-responders to treatment with HD-tDCS
timeFrame: From date of randomization up to 5 weeks
Secondary outcomes:
measure: Neurophysiological characteristics and biomarkers recorded by EEG
timeFrame: Assessed one week before intervention beginning (T0);
measure: Pain Level
timeFrame: From date of randomization (1 week before intervention beginning ) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
measure: Functional Capacity
timeFrame: From date of randomization (1 week before intervention beginning ) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
measure: Quality of Life
timeFrame: From date of randomization (1 week before intervention beginning ) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
measure: Pulmonary Function
timeFrame: From date of randomization (1 week before intervention beginning ) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
measure: Body Composition
timeFrame: From date of randomization (1 week before intervention beginning ) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
measure: Anxiety
timeFrame: From date of randomization (1 week before intervention beginning ) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
measure: Depression
timeFrame: From date of randomization (1 week before intervention beginning ) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
measure: Self-efficacy
timeFrame: From date of randomization (1 week before intervention begining) up to 5 weeks (T1)
Other outcomes:
Locations:
city: João Pessoa,
country: Brazil
facility: Federal University of Paraíba,Department of Psychology
state: Paraiba
Study officials:
References: