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OpenTrials
Completed

NCT Number: NCT03838770

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active tDCS

Device

Active target 2.0mA tDCS (n=60)

Other names: Soterix Mini-Ct Device

Sham tDCS

Device

sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Multiple Sclerosis Society

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 12, 2019
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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