Non-invasive Brain Stimulation in Multiple Sclerosis Fatigue
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCharite University, Berlin, Germany
About this trial
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 criteria
Qualifiers
Men and women
18 - 70 years
Established MS diagnosis (relapsing-remitting MS; RRMS) prior to study inclusion
Maximal EDSS of 4
Disqualifiers
• 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
Trial design
Treatments tested in this trial
- tDCS of dlPFC
- Sham Stimulation of dlPFC
Treatment groups
84 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov