EEG as Predictor of HD-tDCS Effectiveness in Long COVID-19
Predicting Outcomes From HD-tDCS Intervention in Long COVID-19 Using Electroencephalographic Biomarkers and Machine Learning Approach.
1 other identifier
interventional
30
1 country
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 (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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 7, 2022
CompletedFirst Submitted
Initial submission to the registry
March 16, 2022
CompletedFirst Posted
Study publicly available on registry
March 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedMarch 21, 2022
March 1, 2022
5 months
March 16, 2022
March 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Responders and non-responders to treatment with HD-tDCS
Identification of responders and non-responders according to the scores fatigue measured using MFIS-BR.
From date of randomization up to 5 weeks
Secondary Outcomes (9)
Neurophysiological characteristics and biomarkers recorded by EEG
Assessed one week before intervention beginning (T0);
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)
- +4 more secondary outcomes
Study Arms (2)
Experimental Group/ Active HD-tDCS
EXPERIMENTALPatients 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.
Control Group / Sham Group
SHAM COMPARATORPatients 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.
Interventions
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.
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.
Eligibility Criteria
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Sponsors & Collaborators
Study Sites (1)
Federal University of Paraíba,Department of Psychology
João Pessoa, Paraíba, 58051-900, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 16, 2022
First Posted
March 21, 2022
Study Start
February 7, 2022
Primary Completion
June 25, 2022
Study Completion
July 31, 2022
Last Updated
March 21, 2022
Record last verified: 2022-03