tDCS for the Management of Multiple Sclerosis Related Fatigue

Overview

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.

Full Title of Study: “Transcranial Direct Current Stimulation (tDCS) for the Management of Multiple Sclerosis Related Fatigue”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 30, 2021

Interventions

  • Device: Active tDCS
    • Active target 2.0mA tDCS (n=60)
  • Device: sham tDCS
    • sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage

Arms, Groups and Cohorts

  • Experimental: Active
  • Placebo Comparator: Sham

Clinical Trial Outcome Measures

Primary Measures

  • change from baseline in the self-reported Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue instrument.
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NYU Langone Health
  • Collaborator
    • National Multiple Sclerosis Society
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Leigh Charvet, MD, Principal Investigator, New York Langone Medical Center

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