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Recruiting NCT07438964

Non-invasive Brain Stimulation in Multiple Sclerosis Fatigue

No phase Interventional Multiple Sclerosis Fatigue in Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tDCS of dlPFC, Sham Stimulation of dlPFC.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Fatigue in Multiple Sclerosis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device tDCS of dlPFC
    Transcranial direct current stimulation over left dorsolateral prefrontal cortex (DLPFC) for 20 min daily over 5 consecutive days at 1200 uA
  • Device Sham Stimulation of dlPFC
    Sham Stimulation of the dlPFC via tDCS device for 20 minutes on 5 consecutive days

Primary outcome measures

  • Central fatigue [Time frame: At enrolment and 4 days, two weeks and four weeks after enrolment]
  • Neurobehavioral markers of effort discounting [Time frame: At enrolment and 4 days after enrolment]
  • Neurobehavioral markers of habit formation [Time frame: At enrolment and 4 days after enrolment]
  • White matter integrity MRI measure [Time frame: At enrolment and 4 days after enrolment]
  • Brain age marker [Time frame: At enrolment and 4 days after enrolment]
  • Whole-brain grey matter fraction [Time frame: At enrolment and 4 days after enrolment]
  • Whole-brain volume of focal brain lesions [Time frame: At enrolment and 4 days after enrolment]
Secondary outcome measures (7)
  • Change in concentration of inflammatory markers [Time frame: At enrolment and 4 days after enrolment]
  • Change in cognitive performance [Time frame: At enrolment and 4 days after enrolment]
  • Complementary fatigue markers [Time frame: At enrolment, and 4 days, two and four weeks after enrolment]
  • Severity of depressive symptoms [Time frame: At enrolment and 4 days after enrolment]
  • Sleep quality [Time frame: At enrolment and 4 days after enrolment]
  • Severity of anxiety symptoms [Time frame: At enrolment and 4 days after enrolment]
  • Change in Fatigue severity [Time frame: At enrolment, and 1,2,3,4 days, two and four weeks after enrolment]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Charité Campus Mitte — Berlin

Identifiers

NCT: NCT07438964 · FAMS-DFG · EA4/044/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗