NCT07438964Recruiting
Non-invasive Brain Stimulation in Multiple Sclerosis Fatigue
Non-invasive Brain Stimulation for Altering Neuro-inflammatory Mediators of Central Fatigue in Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 12 Feb 2026
- Start date
- 2 Mar 2026
- Primary completion date
- Mar 2028
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Multiple sclerosis
- NCT number
- NCT07438964
What you commit to
- Study type: Interventional
- Planned participants: 84
- From 2 Mar 2026 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • 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
Who the study is looking for
- 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"
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charité Campus Mitte Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.