Electrical Stimulation for Post-Stroke Fatigue

N/A

Recruiting

Led By Hui-Ting Goh

Research Sponsored by Texas Woman's University

Eligibility Criteria Checklist

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

Must have

Have some movement capability in the more affected arm (upper extremity Fugl-Meyer(FMUE) ≥ 28) to ensure they can perform the reaching task

Be at least 18 years old

Must not have

The presence of significant depression (score > 10 on the Patient Health Questionnaire-9)

Significant pain in the upper extremities that interferes with movements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this outcome will be assessed at 2 time points during the study, at baseline and immediately after the intervention ( an average of 7 days from baseline).

Summary

This trial will look at how 5-daily sessions of electrical stimulation can reduce fatigue after stroke. Fatigue will be measured using clinical, behavioral and neurophysiological outcomes.

Who is the study for?

This trial is for adults who've had a stroke at least 3 months ago, can follow simple instructions, and experience significant fatigue (scoring ≥4 on the Fatigue Severity Scale). They should be able to move their affected arm somewhat. People with acute health issues, contraindications to the study's procedures, severe depression, pain that affects arm movement or medications influencing fatigue levels cannot participate.

What is being tested?

The study tests if anodal transcranial direct current stimulation (tDCS) over part of the brain affected by stroke can reduce post-stroke fatigue. Participants will get either real or sham tDCS daily for five days. The effects on behavior and brain function are assessed before, right after treatment and one month later.

What are the potential side effects?

Transcranial direct current stimulation may cause mild side effects like itching, tingling or discomfort at the electrode site during application. Serious side effects are rare but could include skin burns or mood changes.

Eligibility Criteria

Inclusion Criteria

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

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I can move my arm enough to reach out for things.

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I am 18 years old or older.

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I can understand and follow three-step instructions.

Exclusion Criteria

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

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I have significant depression, scoring over 10 on a depression scale.

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I experience severe pain in my arms that affects my movement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this outcome will be assessed at 2 time points during the study, at baseline and immediately after the intervention ( an average of 7 days from baseline).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this outcome will be assessed at 2 time points during the study, at baseline and immediately after the intervention ( an average of 7 days from baseline).

This trial's timeline: 3 weeks for screening, Varies for treatment, and this outcome will be assessed at 2 time points during the study, at baseline and immediately after the intervention ( an average of 7 days from baseline). for reporting.