tDCS for the Management of Multiple Sclerosis Related Fatigue

NCT ID: NCT03838770

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Active

Group Type EXPERIMENTAL

Active tDCS

Intervention Type DEVICE

Active target 2.0mA tDCS (n=60)

Sham

Group Type PLACEBO_COMPARATOR

sham tDCS

Intervention Type DEVICE

sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage

Interventions

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Active tDCS

Active target 2.0mA tDCS (n=60)

Intervention Type DEVICE

sham tDCS

sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage

Intervention Type DEVICE

Other Intervention Names

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Soterix Mini-Ct Device

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Multiple Sclerosis Society

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leigh Charvet, MD

Role: PRINCIPAL_INVESTIGATOR

New York Langone Medical Center

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40735472 (View on PubMed)

Other Identifiers

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18-01406

Identifier Type: -

Identifier Source: org_study_id