NCT03838770

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 4, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

2.2 years

First QC Date

February 11, 2019

Last Update Submit

December 1, 2021

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Active

EXPERIMENTAL
Device: Active tDCS

Sham

PLACEBO COMPARATOR
Device: sham tDCS

Interventions

Active tDCSDEVICE

Active target 2.0mA tDCS (n=60)

Also known as: Soterix Mini-Ct Device
Active
sham tDCSDEVICE

sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage

Sham

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

  • Charvet L, Goldberg J, Li X, Best P, Shaw M, Ryerson LZ, Gutman J, Bikson M, Pilloni G, Krupp L. Enhanced cognitive outcomes with telehealth-based tDCS in multiple sclerosis: Results from a sham-controlled RCT. Mult Scler J Exp Transl Clin. 2025 Jul 28;11(3):20552173251356704. doi: 10.1177/20552173251356704. eCollection 2025 Jul-Sep.

    PMID: 40735472DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Leigh Charvet, MD

    New York Langone Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 12, 2019

Study Start

April 4, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

December 16, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
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.

Locations

US(1)