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

NCT05092516 | Active Not Recruiting Results FDA Device

• 1 other identifier: 2021P002953
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Acute Sequelae of COVID-19; Dysexecutive Syndrome

Keywords

Transcranial Direct Current Stimulation; EEG; Sustained attention

Outcome Measures

Primary Outcomes (6)

• Inhibitory Control

  Performance during the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention). The performance is quantified as the ratio of correct responses to all responses. For example, a score of 0.70 indicates that the participant responded to 70% of the trials correctly.

  Baseline

• Inhibitory Control

  Performance during the incongruent trials of the Eriksen Flanker Task were assessed approximately approximately 4-weeks after baseline. The performance is quantified as the ratio of correct responses to all responses. For example, a score of 0.70 indicates that the participant responded to 70% of the trials correctly.

  Posttreatment (1 month follow-up)

• Processing Speed

  Reaction time during the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention)

  Baseline

• Processing Speed

  Reaction time during the incongruent trials of the Eriksen Flanker Task were assessed approximately 4-weeks after baseline.

  Posttreatment (1 month follow-up)

• EEG P300 Event-related Potential

  EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention). EEG event-related potential amplitudes (measured in microvolts, µV) were normalized across EEG channels using a scaling procedure, in which each channel was rescaled to reduce variability in signal magnitude among electrodes while preserving temporal and spectral characteristics. While larger P300 amplitudes are typically associated with better cognitive outcomes, this can vary among study populations.

  Baseline

• EEG P300 Event-related Potential

  EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task were assessed approximately 4-weeks after baseline. EEG event-related potential amplitudes (measured in microvolts, µV) were normalized across EEG channels using a scaling procedure, in which each channel was rescaled to reduce variability in signal magnitude among electrodes while preserving temporal and spectral characteristics. While larger P300 amplitudes are typically associated with better cognitive outcomes, this can vary among study populations.

  Posttreatment (1 month follow-up)

Secondary Outcomes (6)

• Cognitive Flexibility

  Baseline

• Cognitive Flexibility

  Posttreatment (1 month follow-up)

• Working Memory

  Baseline

• Working Memory

  Posttreatment (1 month follow-up)

• Episodic Memory

  Baseline

Study Arms (2)

Active tDCS

EXPERIMENTAL

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

Sham tDCS

SHAM COMPARATOR

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

Interventions

Active tDCS DEVICE

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.

Active tDCS

Sham tDCS DEVICE

Sham stimulation will be applied to the left prefrontal cortex over the F3 electrode.

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Hamdi Eryilmaz, PhD
• Organization: Massachusetts General Hospital

hamdi.eryilmaz@mgh.harvard.edu

(617) 643-7462

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: October 25, 2021
• Study Start: June 7, 2022
• Primary Completion: March 13, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: April 30, 2026
• Results First Posted: April 30, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)