Home-based Brain Stimulation Treatment for Post-acute Sequelae of COVID-19 (PASC)

Study Overview
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Brief Summary
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The main goal of this study is to improve dysexecutive symptoms (e.g., sustained attention, processing speed) in patients exhibiting post-acute sequelae of COVID-19 (PASC) through home-based transcranial direct current stimulation (tDCS), a noninvasive method that uses low intensity electric currents delivered to the brain through stimulation electrodes on the scalp.

Official Title
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Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Cognitive Post-acute Sequelae of COVID-19 (PASC)

Conditions
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Dysexecutive Syndrome, Post-Acute Sequelae of COVID-19

Intervention / Treatment
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* Device: Active tDCS
* Device: Sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide informed consent A diagnosis of PASC as indicated by past COVID-19 infection, and persistent symptoms, including 'brain fog', confusion, short-term memory deficits, trouble concentrating, delirium, difficulties in multitasking. Exclusion Criteria: History of epilepsy Metallic implants in the head and neck, Brain stimulators Pacemakers Pregnancy Active substance dependence (except for tobacco) Premorbid major neurological illness Severe mental illness (e.g., bipolar disorder, schizophrenia) Attention Deficit Hyperactivity Disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS<br>This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions. | Device: Active tDCS<br>* 2 mA of anodal stimulation will be applied to the left prefrontal cortex over the F3 electrode based on the International 10-10 EEG system.<br>|
| Sham Comparator: Sham tDCS<br>This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions. | Device: Sham tDCS<br>* Sham stimulation will be applied to the left prefrontal cortex over the F3 electrode.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inhibitory control | Performance during the incongruent trials of the Eriksen Flanker Task will be assessed at four time points before, during, and after the 4-week intervention. | 8 weeks | 
| Change in processing speed | Reaction time during the incongruent trials of the Eriksen Flanker Task will be assessed at four time points before, during, and after the 4-week intervention. | 8 weeks | 
| Change in EEG P300 event-related potential | EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task will be assessed at four time points before, during, and after the 4-week intervention. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Direct Current Stimulation, EEG, Sustained attention