tDCS for the Management of Multiple Sclerosis Related Fatigue

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Device: Active tDCS; Device: sham tDCS

• Registration Number: NCT03838770
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-11
• Study First Posted: 2019-02-12
• Study Start: 2019-04-04
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Active tDCS	-
Sham	sham tDCS	-

Primary Outcome Measures

Name	Time	Method
change from baseline in the self-reported Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue instrument.	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States