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

N/AActive Not RecruitingNCT05092516

Massachusetts General Hospital40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dysexecutive Syndrome Post-Acute Sequelae of COVID-19

Interventions

Active tDCSDEVICE

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 tDCSDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Charlestown, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

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.

Time frame: 8 weeks

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.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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