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Brain Stimulation

Home-Based Brain Stimulation for Post-COVID Syndrome

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Must not have

Metallic implants in the head and neck

History of epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Summary

This trial is testing whether tDCS can help improve attention and processing speed in people who have experienced long-term effects of COVID-19.

Who is the study for?

This trial is for individuals who have had COVID-19 and are now experiencing persistent symptoms like 'brain fog', confusion, memory issues, concentration problems, or delirium. Candidates must be able to consent and not have a major neurological condition before COVID-19, metal implants in the head/neck area, brain stimulators, epilepsy history, pacemakers, active substance dependence (except tobacco), ADHD or severe mental illness.

What is being tested?

The study tests if home-based transcranial direct current stimulation (tDCS) can improve cognitive functions such as attention and processing speed in patients with post-COVID conditions. Participants will receive either an active tDCS treatment or a sham (placebo-like) version to compare effects.

What are the potential side effects?

tDCS may cause mild side effects including itching, tingling or burning sensation at the electrode sites during application. There might also be fatigue or headaches following treatment but these are generally considered rare and mild.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have long-term symptoms from COVID-19, like 'brain fog' and memory issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have metal implants in my head or neck.

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I have a history of epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in EEG P300 event-related potential

Change in inhibitory control

Change in processing speed

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCSExperimental Treatment1 Intervention

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.

Group II: Sham tDCSPlacebo Group1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Active tDCS

2012

Completed Phase 1

~1190

0 / 3Eligibility criteria met