tDCS for the Management of Multiple Sclerosis Related Fatigue
NCT ID: NCT03838770
Last Updated: 2021-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
122 participants
INTERVENTIONAL
2019-04-04
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Active
Active tDCS
Active target 2.0mA tDCS (n=60)
Sham
sham tDCS
sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage
Interventions
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Active tDCS
Active target 2.0mA tDCS (n=60)
sham tDCS
sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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National Multiple Sclerosis Society
OTHER
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Leigh Charvet, MD
Role: PRINCIPAL_INVESTIGATOR
New York Langone Medical Center
Locations
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NYU Langone Health
New York, New York, United States
Countries
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References
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Charvet L, Goldberg J, Li X, Best P, Shaw M, Ryerson LZ, Gutman J, Bikson M, Pilloni G, Krupp L. Enhanced cognitive outcomes with telehealth-based tDCS in multiple sclerosis: Results from a sham-controlled RCT. Mult Scler J Exp Transl Clin. 2025 Jul 28;11(3):20552173251356704. doi: 10.1177/20552173251356704. eCollection 2025 Jul-Sep.
Other Identifiers
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18-01406
Identifier Type: -
Identifier Source: org_study_id