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

Respiratory Infection Clinical Trial

Official title:

Predicting Outcomes From HD-tDCS Intervention in Long COVID-19 Using Electroencephalographic Biomarkers and Machine Learning Approach.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05289128
• Other study ID #: LongCOVID/EEG/HDtDCS
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: July 31, 2022

Study information

• Verified date: March 2022
• Source: Federal University of Paraíba
• Contact: Suellen Andrade, Phd
• Phone: 986046032
• Email: suellenandrade[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2022
• Est. primary completion date: June 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus COVID-19
• COVID-19
• Respiratory Infection
• Respiratory Tract Infections

Intervention

Device:
• Experimental group
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.
• Sham Control
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.

Locations

Country	Name	City	State
Brazil	Federal University of Paraíba,Department of Psychology	João Pessoa,	Paraiba

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Assessed one week before intervention beginning (T0);
Secondary	Pain Level	Pain level will be evaluated through McGill questionnaire considering pain multifactorial characteristics.	From date of randomization (1 week before intervention beginning ) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
Secondary	Functional Capacity	Functional capacity will be evaluated by Lawton and Brody scale and also by 6 minutes walking test.	From date of randomization (1 week before intervention beginning ) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
Secondary	Quality of Life	Quality of life will be measured through Brazilian version of World Health Organization 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)
Secondary	Pulmonary Function	This outcome will be assessed through spirometry, assessment of maximal inspiratory pressure and respiratory endurance.	From date of randomization (1 week before intervention beginning ) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
Secondary	Body Composition	Body composition analysis will be carried out by bioelectrical impedance analysis.	From date of randomization (1 week before intervention beginning ) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
Secondary	Anxiety	Anxiety level will be evaluate through Hamilton Anxiety Rating Scale which measures the severity of anxiety symptoms.	From date of randomization (1 week before intervention beginning ) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
Secondary	Depression	Depression will be assessed by Beck's Depression Inventory.	From date of randomization (1 week before intervention beginning ) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up)
Secondary	Self-efficacy	Self-efficacy will be evalluated through the Self-efficacy manage chronic disease 6-item scale.	From date of randomization (1 week before intervention begining) up to 5 weeks (T1)