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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05092516
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
14
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Active tDCS
  • Device: Sham tDCS
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Cognitive Post-acute Sequelae of COVID-19 (PASC)
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Charlestown Massachusetts United States 02129

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hamdi Eryilmaz, PhD, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT05092516
Other Study ID Numbers:
  • 2021P002953
First Posted:
Oct 25, 2021
Last Update Posted:
Apr 11, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Hamdi Eryilmaz, PhD, Assistant Professor, Massachusetts General Hospital
Transcranial Direct Current Stimulation
EEG
Sustained attention
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Apr 11, 2022