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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
tDCS of dlPFC
DeviceTranscranial direct current stimulation over left dorsolateral prefrontal cortex (DLPFC) for 20 min daily over 5 consecutive days at 1200 uA
Sham Stimulation of dlPFC
DeviceSham Stimulation of the dlPFC via tDCS device for 20 minutes on 5 consecutive days
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: tDCS Stimulation of dlPFCActive comparator 1 intervention
Group B: Sham Stimulation of dlPFCSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Central fatigue
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
Time frame
At enrolment and 4 days, two weeks and four weeks after enrolment2
Neurobehavioral markers of effort discounting
Measured in a functional MRI (fMRI) task
Time frame
At enrolment and 4 days after enrolment3
Neurobehavioral markers of habit formation
Measured in an fMRI task
Time frame
At enrolment and 4 days after enrolment4
White matter integrity MRI measure
Computed as voxel-wise quotients of T1-weighted and T2-weigted anatomical MRI brain scan parameters
Time frame
At enrolment and 4 days after enrolmentSecondary outcomes
1
Change in concentration of inflammatory markers
124 blood-derived inflammatory cytokine and chemokine markers determined via an inflammatory panel
Time frame
At enrolment and 4 days after enrolment2
Change in cognitive performance
Brief International Cognitive Assessment for MS (BICAMS)
Time frame
At enrolment and 4 days after enrolment3
Complementary fatigue markers
Fatigue Severity Scale (FSS), Minimum value 7, Maximum value 63, higher score denoting a worse outcome.
Time frame
At enrolment, and 4 days, two and four weeks after enrolment4
Severity of depressive symptoms
Beck Depression Inventory (BDI-II), Minimum value 0, Maximum value 63, higher values denoting worse outcome
Time frame
At enrolment and 4 days after enrolmentSponsors and contacts
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Source ClinicalTrials.gov