RecruitingNot ApplicableNCT07438964

Non-invasive Brain Stimulation in Multiple Sclerosis Fatigue

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


Sponsor

Charite University, Berlin, Germany

Enrollment

84 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing non-invasive brain stimulation techniques to help reduce fatigue in people with relapsing-remitting multiple sclerosis (MS) — the most common type of MS where symptoms come and go. The study includes both MS patients who experience fatigue and those who do not, to compare effects. **You may be eligible if...** - You are between 18 and 70 years old - You have a confirmed diagnosis of relapsing-remitting MS - Your MS disability level is mild (EDSS score of 4 or below) - You have had MS for 10 years or less - Your MS treatment has been stable (or you are not on treatment) for the last 6 months - You have health insurance **You may NOT be eligible if...** - You cannot have an MRI (e.g., due to metal implants) - You have another significant neurological, immune, or psychiatric condition besides MS (depression is sometimes acceptable) - You are taking certain medications that affect brain chemistry (such as levodopa, fluoxetine, paroxetine, or antipsychotics) - You had an MS relapse or took steroids in the last 4 weeks - You have a sleep disorder - You are on certain MS disease-modifying therapies (other than B-cell depleting drugs or fumarates) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEtDCS of dlPFC

Transcranial direct current stimulation over left dorsolateral prefrontal cortex (DLPFC) for 20 min daily over 5 consecutive days at 1200 uA

DEVICESham Stimulation of dlPFC

Sham Stimulation of the dlPFC via tDCS device for 20 minutes on 5 consecutive days


Locations(1)

Charité Campus Mitte

Berlin, State of Berlin, Germany

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NCT07438964


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