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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dysexecutive Syndrome; Post-Acute Sequelae of COVID-19
• Intervention / Treatment: Device: Active tDCS; Device: Sham tDCS

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Active tDCS; 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.
Sham Comparator: 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.	Device: Sham tDCS; Sham stimulation will be applied to the left prefrontal cortex over the F3 electrode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Flexibility	Performance on the NIH Toolbox Dimensional Change Card Sort Test, a computerized measure of executive function assessing cognitive flexibility, attention, and set-shifting. Participants match target stimuli based on changing rules (e.g., color or shape). Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better cognitive flexibility and executive control.	Baseline
Cognitive Flexibility	Performance on the NIH Toolbox Dimensional Change Card Sort Test, a computerized measure of executive function assessing cognitive flexibility, attention, and set-shifting. Participants match target stimuli based on changing rules (e.g., color or shape). Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better cognitive flexibility and executive control.	Posttreatment (1 month follow-up)
Working Memory	Performance on the NIH Toolbox List Sorting Working Memory Test, which assesses working memory capacity through sequencing and recall of visually and verbally presented stimuli in size order. The task requires temporary storage and manipulation of information across increasing list lengths. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better working memory performance.	Baseline
Working Memory	Performance on the NIH Toolbox List Sorting Working Memory Test, which assesses working memory capacity through sequencing and recall of visually and verbally presented stimuli in size order. The task requires temporary storage and manipulation of information across increasing list lengths. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better working memory performance.	Posttreatment (1 month follow-up)
Episodic Memory	Performance on the NIH Toolbox Picture Sequence Memory Test, a measure of episodic memory in which participants reproduce the order of a sequence of visually presented pictures. The task assesses the ability to encode, store, and retrieve sequential information. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better episodic memory function.	Baseline
Episodic Memory	Performance on the NIH Toolbox Picture Sequence Memory Test, a measure of episodic memory in which participants reproduce the order of a sequence of visually presented pictures. The task assesses the ability to encode, store, and retrieve sequential information. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better episodic memory function.	Posttreatment (1 month follow-up)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2022
• Primary Completion (Actual): March 13, 2025
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Transcranial Direct Current Stimulation; EEG; Sustained attention
• Additional Relevant MeSH Terms: Post-Infectious Disorders; COVID-19; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 2021P002953

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes