Multiple Sclerosis
Conditions
Brief summary
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.
Interventions
DEVICEActive tDCS
Active target 2.0mA tDCS (n=60)
DEVICEsham tDCS
sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage
Sponsors
National Multiple Sclerosis Society
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in the self-reported Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue instrument. | 7 Days post end of Treatment | 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. |
Countries
United States
Outcome results
None listed