Back to resultstDCS for the Management of Multiple Sclerosis Related Fatigue
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active tDCS
sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility 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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Sham
Arm Description
Outcomes
Primary Outcome Measures
change from baseline in the self-reported Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue instrument.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03838770
First Posted
February 11, 2019
Last Updated
December 1, 2021
Sponsor
NYU Langone Health
Collaborators
National Multiple Sclerosis Society
1. Study Identification
Unique Protocol Identification Number
NCT03838770
Brief Title
tDCS for the Management of Multiple Sclerosis Related Fatigue
Official Title
Transcranial Direct Current Stimulation (tDCS) for the Management of Multiple Sclerosis Related Fatigue
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 4, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Multiple Sclerosis Society
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Title
Sham
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Active tDCS
Other Intervention Name(s)
Soterix Mini-Ct Device
Intervention Description
Active target 2.0mA tDCS (n=60)
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage
Primary Outcome Measure Information:
Title
change from baseline in the self-reported Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue instrument.
Description
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.
Time Frame
7 Days post end of Treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh Charvet, MD
Organizational Affiliation
New York Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication.
IPD Sharing 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.
Learn more about this trial
tDCS for the Management of Multiple Sclerosis Related Fatigue
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