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tDCS for the Management of Multiple Sclerosis Related Fatigue

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ClinicalTrials.gov Identifier: NCT03838770
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Active tDCS Device: sham tDCS Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) for the Management of Multiple Sclerosis Related Fatigue
Estimated Study Start Date : February 27, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Device: Active tDCS
Active target 2.5 mA tDCS (n=60)
Other Name: Soterix Mini-Ct Device

Placebo Comparator: Sham Device: sham tDCS
sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≥4
  • Current chronic headaches or migraines
  • Skin disorder/sensitive near stimulation locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838770


Contacts
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Contact: Kai Sherman 929 455 5141 Kathleen.Sherman@nyulangone.org

Sponsors and Collaborators
NYU Langone Health
National Multiple Sclerosis Society
Investigators
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Principal Investigator: Leigh Sherman, MD New York Langone Medical Center

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03838770     History of Changes
Other Study ID Numbers: 18-01406
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication.
Access Criteria: For individual participant data meta-analysis. Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms