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

Primary Purpose

Dysexecutive Syndrome, Post-Acute Sequelae of COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active tDCS
Sham tDCS
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysexecutive Syndrome focused on measuring Transcranial Direct Current Stimulation, EEG, Sustained attention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in inhibitory control
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
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.
Change in EEG P300 event-related potential
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.

Secondary Outcome Measures

Full Information

First Posted
October 21, 2021
Last Updated
September 1, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05092516
Brief Title
Home-based Brain Stimulation Treatment for Post-acute Sequelae of COVID-19 (PASC)
Official Title
Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Cognitive Post-acute Sequelae of COVID-19 (PASC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysexecutive Syndrome, Post-Acute Sequelae of COVID-19
Keywords
Transcranial Direct Current Stimulation, EEG, Sustained attention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
Sham stimulation will be applied to the left prefrontal cortex over the F3 electrode.
Primary Outcome Measure Information:
Title
Change in inhibitory control
Description
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.
Time Frame
8 weeks
Title
Change in processing speed
Description
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.
Time Frame
8 weeks
Title
Change in EEG P300 event-related potential
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamdi Eryilmaz, Ph.D.
Phone
6176437462
Email
hamdi.eryilmaz@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra O'Neill, B.S.
Phone
(617) 726-8753
Email
agoneill@mgh.harvard.edu
Facility Information:
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra O'Neill, B.S.
Phone
617-726-8753
Email
agoneill@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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