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RECRUITING
NCT07438964
NA

Non-invasive Brain Stimulation in Multiple Sclerosis Fatigue

Sponsor: Charite University, Berlin, Germany

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2026-03-02

Completion Date

2028-06

Last Updated

2026-02-27

Healthy Volunteers

No

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

Locations (1)

Charité Campus Mitte

Berlin, State of Berlin, Germany