tDCS of dlPFC: Transcranial direct current stimulation over left dorsolateral prefrontal cortex (DLPFC) for 20 min daily over 5 consecutive days at 1200 uA
Sham Stimulation of dlPFC: Sham Stimulation of the dlPFC via tDCS device for 20 minutes on 5 consecutive days
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Central fatigue — At enrolment and 4 days, two weeks and four weeks after enrolment Assessed with cognitive subscale of with Fatigue Scale for Motor and Cognitive Functions (FSMC): Minimum 20 points, maximum 100 points, higher values denoting worse outcome
Neurobehavioral markers of effort discounting — At enrolment and 4 days after enrolment Measured in a functional MRI (fMRI) task
Neurobehavioral markers of habit formation — At enrolment and 4 days after enrolment Measured in an fMRI task
White matter integrity MRI measure — At enrolment and 4 days after enrolment Computed as voxel-wise quotients of T1-weighted and T2-weigted anatomical MRI brain scan parameters
Brain age marker — At enrolment and 4 days after enrolment Inferred via machine learning from anatomical T1-weighted brain scan
Whole-brain grey matter fraction — At enrolment and 4 days after enrolment Inferred from anatomical T1-weighted brain MRI scans
Whole-brain volume of focal brain lesions — At enrolment and 4 days after enrolment Inferred from anatomical T2-weighted brain MRI scans
Trial sites (1)
Facility
City
Region
Status
Charité Campus Mitte
Berlin
State of Berlin
Recruiting
More Charite University, Berlin, Germany trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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