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

Mass General Brigham

Status: Active, not recruiting

Conditions: Post-Acute Sequelae of COVID-19; Dysexecutive Syndrome

Treatments: Device: Active tDCS; Device: Sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT05092516

2021P002953

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Active tDCS

Experimental group

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.

Treatment:

Device: Active tDCS

Sham tDCS

Sham Comparator group

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.

Treatment:

Device: Sham tDCS