Status:
COMPLETED
tDCS for the Management of Multiple Sclerosis Related Fatigue
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Multiple Sclerosis Society
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT03838770
Start Date
April 4 2019
End Date
June 30 2021
Last Update
December 16 2021
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016