Non-invasive Brain Stimulation in Multiple Sclerosis Fatigue

Non-invasive Brain Stimulation for Altering Neuro-inflammatory Mediators of Central Fatigue in Multiple Sclerosis

RecruitingNot a drug-phase studyRelapsing MSNCT07438964

What it found

Still running

No result yet.

What was tested

Treatment tested

  • tDCS of dlPFC

Placebo

  • Sham Stimulation of dlPFC

What it measured

Main measures

  • Central fatigue

    At enrolment and 4 days, two weeks and four weeks after enrolment

    Thinking and memoryFatigue

  • Neurobehavioral markers of effort discounting

    At enrolment and 4 days after enrolment

    MRI lesionsNerve conduction tests

  • Neurobehavioral markers of habit formation

    At enrolment and 4 days after enrolment

    Nerve conduction tests

  • White matter integrity MRI measure

    At enrolment and 4 days after enrolment

    MRI lesions

  • Brain age marker

    At enrolment and 4 days after enrolment

    MRI lesions

  • Whole-brain grey matter fraction

    At enrolment and 4 days after enrolment

    MRI lesionsBrain volume loss

  • Whole-brain volume of focal brain lesions

    At enrolment and 4 days after enrolment

    MRI lesionsBrain volume loss

Other measures (7)

  • Change in concentration of inflammatory markers

    At enrolment and 4 days after enrolment

    Immune response

  • Change in cognitive performance

    At enrolment and 4 days after enrolment

    Thinking and memory

  • Complementary fatigue markers

    At enrolment, and 4 days, two and four weeks after enrolment

    Fatigue

  • Severity of depressive symptoms

    At enrolment and 4 days after enrolment

    Mood and sleep

  • Sleep quality

    At enrolment and 4 days after enrolment

    Mood and sleep

  • Severity of anxiety symptoms

    At enrolment and 4 days after enrolment

    Mood and sleep

  • Change in Fatigue severity

    At enrolment, and 1,2,3,4 days, two and four weeks after enrolment

    Fatigue

Who could take part

Relapsing MS · 18 to 70

Show the full criteria

Inclusion criteria

* Men and women * 18 - 70 years * Established MS diagnosis (relapsing-remitting MS; RRMS) prior to study inclusion * Maximal EDSS of 4 * Maximal disease duration 10 years * Existing health insurance * Stable or no treatment with disease modifying treatment (DMT) in last six months prior to study onset * Persons with RRMS and FSMC score ≥ 22 will be included in group "RRMS with fatigue" * Persons with RRMS and FSMC score \< 22 will be included in group "RRMS without fatigue"

Exclusion criteria

* • MRI contraindications * Known endocrine, immunologic, psychiatric, and neurologic disease (other than RRMS and Major Depressive Diosorder) * Current treatment with pharmaceuticals affecting monoaminergic functioning such as Levodopa, Amantadin, Fluoxetin, Paroxetin or antipsychotics * Relapse or treatment with steroids in last four weeks window prior to study onset * DMT other than B-cell depleting monoclonal antibodies or fumarates * Sleep disorder as assessed with Pittsburgh Sleep Quality Index

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

Contact details on the registry

About this trial

In the sponsor's words

The neurobiological basis of central fatigue in multiple sclerosis remained unclear so far. This study investigates reward-related brain mechanisms, inflammation, and their modulation by non-invasive brain stimulation using fMRI, proteomics, and clinical measures to improve future treatment of central fatigue in MS. In the study, persons suffering from relapsing-remitting MS (RRMS) with vs. without comorbid central fatigue will be included. The study comprises five experimental visits conducted at Charité University Medicine on five consecutive days (i.e., V1 - V5) and two follow-up visits two (V6) and four (V7) weeks after V5. True or sham anodal transcranial Direct Current Stimulation (tDCS) is applied to the left dorsolateral prefrontal cortex (dlPFC) at the five visits V1 to V5. All primary and secondary outcomes are assessed at V1 and V5. At V6 and V7, measures of central fatigue are additionally assessed via questionnaires which are send to and back from the patients via mail. Participants of all groups will participate in all visits.

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History

    1. Started

      Mar 2026

    2. Main results due

      Mar 2028

    3. Finished

      Jun 2028

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