tDCS for the Management of Multiple Sclerosis Related Fatigue

Study Overview
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Brief Summary
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This is a pragmatic clinical trial that aims to determine the effect of tDCS on symptomatic fatigue in Multiple Sclerosis (MS) patients. This is a randomized, blinded, sham-controlled study design to determine the effect of Transcranial Direct Current Stimulation (tDCS) on MS participants to reduce feelings of fatigue.120 participants with MS and clinically-significant fatigue (as defined by a score of >36 on the Fatigue Severity Scale) will be recruited to participate in either an active or sham treatment condition.

Official Title
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Transcranial Direct Current Stimulation (tDCS) for the Management of Multiple Sclerosis Related Fatigue

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: Active tDCS
* Device: sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Definite MS diagnosis, all subtypes Fatigue Severity Scale score of 36 or greater Score of 7.5 or less on the Expanded Disability Status Scale (EDSS) (with caregiver proxy required for those with scores of 7.5 or greater) Ability to understand the informed consent process and provide consent to participate in the study Exclusion Criteria: Primary neurologic, psychiatric or other medical disorder other than MS History of seizures or seizure disorder History of head trauma or medical device in head or neck Clinically significant abnormality on EKG Current symptomatic treatment for fatigue Symbol Digit Modalities Test or SDMT score≥3.0 SD from published norms WRAT-4 reading level below average (<85) (estimated general intellectual function) Beck Depression Inventory-Fast Screen (BDI- FS) score ≥10 Current chronic headaches or migraines Skin disorder/sensitive near stimulation locations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Active<br> | Device: Active tDCS<br>* Active target 2.0mA tDCS (n=60)<br>* Other names: Soterix Mini-Ct Device;|
| Placebo Comparator: Sham<br> | Device: sham tDCS<br>* sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in the self-reported Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue instrument. | The minimally important difference representing a clinically significant improvement in patient-reported fatigue on the 7-item PROMIS Fatigue Scale is defined as a 3.0 point change in raw score. Clinically-significant response to tDCS treatment by the conservative measurement of >3.0 points on the PROMIS Fatigue Scale. | 7 Days post end of Treatment |