tDCS for the Management of Multiple Sclerosis Related Fatigue
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About
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.
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
122 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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