Post-stroke Fatigue, Inflammation, tDCS

Study Overview
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Brief Summary
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Fatigue is a common condition after an individual has a stroke. While the negative impacts of post-stroke fatigue are well known, the knowledge of the causes of post-stroke fatigue and effective treatments for post-stroke fatigue are lacking. This small study will investigate the possible benefits of transcranial direct current stimulation (tDCS), which uses small electrical currents supplied by a 9-volt battery, on post-stroke fatigue and investigate tDCS' possible anti-inflammatory effects.

Official Title
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Effects of tDCS on Post-stroke Fatigue and Inflammation

Conditions
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Chronic Stroke, Stroke Sequelae, Stroke, Fatigue

Intervention / Treatment
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* Device: anodal transcranial direct current stimulation (a-tDCS)
* Device: sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women of any race or ethnicity 35-80 years of age 6+ months post-stroke Have clinically present fatigue for 6 months Able to walk 10m unassisted Exclusion Criteria: Absolute contraindications to MRI, TMS (transcranial magnetic stimulation), or tDCS (e.g., implanted metal devices, history of seizure, and surgical clips or staples) Inability to understand and provide written informed consent Multiple strokes on opposite hemispheres Diagnosed comorbid neurological conditions (e.g. multiple sclerosis, Parkinson's disease, and dementia) Severe hypertension Cerebellar or brainstem strokes/lesions Concurrent depression and/or anxiety disorders

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real<br>Randomly selected participants will receive 20 min. of anodal transcranial direct current stimulation to the the top of their heads. The current will slowly be ramped up over 30 secs. | Device: anodal transcranial direct current stimulation (a-tDCS)<br>* The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.<br>* Other names: 1x1 - tDCS, Soterix Medical, US Patents: US9956395B2, US8818515B2, US8718778B2.;|
| Sham Comparator: Sham<br>Randomly selected participants will receive 20 min. of sham transcranial direct current stimulation to the top of their heads. Sham stimulation is accomplished by turning on the device and slowly increasing and subsequently decreasing the amount of current to zero. This occurs over 30 secs. | Device: sham stimulation<br>* The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.<br>* Other names: 1x1 - tDCS, Soterix Medical, US Patents: US9956395B2, US8818515B2, US8718778B2.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fatigue Severity Scale (FSS) score | Patient reported outcome measuring trait fatigue over the past 7 days. Minimum score = 7 maximum score = 63, higher scores indicate greater fatigue | Baseline, post-intervention (2-weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fatigue Assessment Scale (FAS) | Patient reported outcome measuring trait fatigue. Minimum score = 10 maximum score = 50, higher scores indicate greater fatigue | Baseline, post-intervention (2-weeks) |