Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Cognitive Post-acute Sequelae of COVID-19 (PASC)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Change in EEG P300 event-related potential
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: Sham tDCS (Device)
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.
Intervention: Active tDCS (Device)
Outcomes
Primary Outcomes
Change in EEG P300 event-related potential
Time Frame: 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.
Change in inhibitory control
Time Frame: 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.
Change in processing speed
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Hamdi Eryilmaz, PhD
Assistant Professor
Massachusetts General Hospital