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

Not Applicable

Active, not recruiting

• Conditions: Post-Acute Sequelae of COVID-19; Dysexecutive Syndrome
• Interventions: Device: Sham tDCS; Device: Active tDCS

• Registration Number: NCT05092516
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-10-25
• Study Start: 2022-06-07
• Primary Completion: 2025-03-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS	Sham tDCS	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.
Active tDCS	Active tDCS	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.

Primary Outcome Measures

Name	Time	Method
Change in EEG P300 event-related potential	8 weeks	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.
Change in inhibitory control	8 weeks	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.
Change in processing speed	8 weeks	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Charlestown, Massachusetts, United States