Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT07438964

Non-invasive Brain Stimulation in Multiple Sclerosis Fatigue

Led by Charite University, Berlin, Germany · Updated on 2026-02-27

84

Participants Needed

1

Research Sites

117 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Non-invasive Brain Stimulation in Multiple Sclerosis Fatigue

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged 18 to 70 years
  • Confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS) before joining the study
  • Maximum Expanded Disability Status Scale (EDSS) score of 4
  • Disease duration no longer than 10 years
  • Have existing health insurance
  • Stable or no disease modifying treatment (DMT) in the last six months before study starts
  • RRMS patients with Fatigue Scale for Motor and Cognitive Functions (FSMC) score of 22 or higher assigned to "RRMS with fatigue" group
  • RRMS patients with FSMC score below 22 assigned to "RRMS without fatigue" group
Not Eligible

You will not qualify if you...

  • Any contraindications to MRI
  • Known endocrine, immunologic, psychiatric, or neurologic diseases other than RRMS and Major Depressive Disorder
  • Current treatment with drugs affecting monoaminergic function such as Levodopa, Amantadin, Fluoxetine, Paroxetine, or antipsychotics
  • Relapse or steroid treatment within the four weeks before study start
  • Use of disease modifying treatments other than B-cell depleting monoclonal antibodies or fumarates
  • Sleep disorders as identified by the Pittsburgh Sleep Quality Index

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Charité Campus Mitte

Berlin, State of Berlin, Germany, 10117

Actively Recruiting

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Research Team

J

Janina Dr. Behrens, Dr. med.

CONTACT

M

Martin Dr. Weygandt, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Non-invasive Brain Stimulation in Multiple Sclerosis Fatigue | DecenTrialz