tDCS for the Management of Multiple Sclerosis Related Fatigue

Transcranial Direct Current Stimulation (tDCS) for the Management of Multiple Sclerosis Related Fatigue

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Active tDCS; Device: sham tDCS

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active	Device: Active tDCS; Active target 2.0mA tDCS (n=60); Other Names: Soterix Mini-Ct Device
Placebo Comparator: Sham	Device: sham tDCS; sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 Days post end of Treatment

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Multiple Sclerosis Society
• Investigators: Principal Investigator: Leigh Charvet, MD, New York Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 18-01406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• 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