Non-invasive Brain Stimulation in Multiple Sclerosis Fatigue
NCT07438964 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2026-02-27
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.
Conditions
- Multiple Sclerosis
- Fatigue in Multiple Sclerosis
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
Sponsors & Collaborators
-
Charite University, Berlin, Germany
lead OTHER
Principal Investigators
-
Chotima Dr. Böttcher, PhD · Max-Delbrück-Centrum Berlin
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-02
- Primary Completion
- 2028-03-31
- Completion
- 2028-06-30
Countries
- Germany
Study Locations
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