Non-invasive brain stimulation for multiple sclerosis fatigue
Non-invasive Brain Stimulation for Altering Neuro-inflammatory Mediators of Central Fatigue in Multiple Sclerosis
NA · Charite University, Berlin, Germany · NCT07438964
This study will see if repeated non-invasive brain stimulation of the left dorsolateral prefrontal cortex reduces fatigue in adults with relapsing-remitting multiple sclerosis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany (other) |
| Locations | 1 site (Berlin, State of Berlin) |
| Trial ID | NCT07438964 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study enrolls adults with relapsing-remitting MS with and without central fatigue and applies either true or sham anodal transcranial direct current stimulation (tDCS) to the left dorsolateral prefrontal cortex on five consecutive daily visits (V1–V5). Participants undergo fMRI, blood-based proteomics, and clinical measures at baseline and after the five stimulation sessions, with additional questionnaire follow-ups at two and four weeks (V6, V7). The design compares changes in reward-related brain activity, inflammatory markers, and fatigue scores between groups and stimulation arms. Primary and secondary outcomes are assessed at V1 and V5.
Who should consider this trial
Good fit: Ideal candidates are adults 18–70 with relapsing-remitting MS (EDSS ≤4, disease duration ≤10 years), insured, on stable or no disease-modifying treatment for at least six months, able to undergo MRI, and able to attend five consecutive study visits, with fatigue status defined by FSMC score.
Not a fit: People with progressive MS, higher disability (EDSS >4), recent relapse or steroid treatment, MRI contraindications, or current use of excluded monoaminergic medications or incompatible DMTs are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this approach could reduce central fatigue and provide a non-drug treatment option to improve daily functioning for people with relapsing-remitting MS.
How similar studies have performed: Small prior trials of tDCS for MS fatigue have produced mixed but sometimes promising symptom reductions, while combining fMRI and proteomics to study reward-related mechanisms is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berlin, State of Berlin
- Charité Campus Mitte — Berlin, State of Berlin, Germany (RECRUITING)
Study contacts
- Principal investigator: Chotima Dr. Böttcher, PhD — Max-Delbrück-Centrum Berlin
- Study coordinator: Janina Dr. Behrens, Dr. med.
- Email: janina.behrens@charite.de
- Phone: +49 30 7560921
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Sclerosis, Fatigue in Multiple Sclerosis, Transcranial direct current stimulation, Fatigue