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OpenTrials
Active, Not Recruiting

NCT Number: NCT05092516

Home-based Brain Stimulation Treatment for 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sham tDCS

Device

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

Primary outcomes

  1. Inhibitory Control

    Time frame: Baseline

    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.

  2. Inhibitory Control

    Time frame: Posttreatment (1 month follow-up)

    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.

  3. Processing Speed

    Time frame: Baseline

    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)

  4. Processing Speed

    Time frame: Posttreatment (1 month follow-up)

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

  5. EEG P300 Event-related Potential

    Time frame: Baseline

    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.

  6. EEG P300 Event-related Potential

    Time frame: Posttreatment (1 month follow-up)

    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.

Secondary outcomes

  1. Cognitive Flexibility

    Time frame: Baseline

    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.

  2. Cognitive Flexibility

    Time frame: Posttreatment (1 month follow-up)

    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.

  3. Working Memory

    Time frame: Baseline

    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.

  4. Working Memory

    Time frame: Posttreatment (1 month follow-up)

    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.

  5. Episodic Memory

    Time frame: Baseline

    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.

  6. Episodic Memory

    Time frame: Posttreatment (1 month follow-up)

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Oct 25, 2021
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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