tDCS for Post-Stroke Fatigue

Phase 2

Recruiting

Led By Joan M Stilling, MD, MS

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

Fatigue severity score average >4 (severe fatigue)

Be older than 18 years old

Must not have

Signs of skin rash, infection, or laceration in the supraorbital region where the tDCS will be applied

History of seizure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening (-1 to -14 days), baseline (day 1), during-treatment (day 7-9), post-treatment (day 14-21), 1 month post-treatment (day 45-52)

Summary

This trial will explore if mild electric stimulation of the brain can reduce fatigue after a stroke.

Who is the study for?

This trial is for adults over 18 who've had their first stroke more than 3 months ago and are experiencing severe fatigue. They must have a stable medication routine and someone to accompany them during treatment sessions. People with metal in the head, pacemakers, seizure history, severe brain injuries, depression/anxiety or cognitive disorders, skin issues where the device will be placed, or other major health problems can't participate.

What is being tested?

The study tests if anodal tDCS (a non-invasive brain stimulation technique) applied to the left frontal area of the head can reduce post-stroke fatigue. Participants will receive either real tDCS using Soterix Mini-CT stimulator or a sham (fake) version to compare effects.

What are the potential side effects?

tDCS may cause mild side effects like itching, tingling at the electrode site during application, headache, fatigue after treatment or discomfort. Serious side effects are rare but could include seizures or skin irritation under electrodes.

Eligibility Criteria

Inclusion Criteria

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

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I experience severe fatigue.

Exclusion Criteria

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

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I have no skin issues like rash or cuts where the device will be placed on my head.

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I have had seizures in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening (-1 to -14 days), baseline (day 1), during-treatment (day 7-9), post-treatment (day 14-21), 1 month post-treatment (day 45-52)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening (-1 to -14 days), baseline (day 1), during-treatment (day 7-9), post-treatment (day 14-21), 1 month post-treatment (day 45-52)

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening (-1 to -14 days), baseline (day 1), during-treatment (day 7-9), post-treatment (day 14-21), 1 month post-treatment (day 45-52) for reporting.