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

CompletedNot a drug-phase studyMS (type not specified)NCT03838770

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Active tDCS

Placebo

  • sham tDCS

What it measured

Main measures

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

    7 Days post end of Treatment

    FatigueQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 70

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Apr 2019

    2. Main results due

      Jun 2021

    3. Finished

      Jun 2021

    Assembled by software from public sources.