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tDCS for the Management of Multiple Sclerosis Related Fatigue

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ClinicalTrials.gov Identifier: NCT03838770
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : May 4, 2020
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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 Not Applicable

Study Design
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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
Actual Study Start Date : April 4, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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.


Eligibility Criteria
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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 ≥10
  • Current chronic headaches or migraines
  • Skin disorder/sensitive near stimulation locations
Contacts and Locations
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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

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Michael Shaw    929-455-5141    michael.shaw@nyulangone.org   
Principal Investigator: Leigh Charvet, MD         
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
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03838770    
Other Study ID Numbers: 18-01406
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: May 2020
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: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases