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| ID | Type | Description | Link |
|---|---|---|---|
| EA4/044/25 | Other Grant/Funding Number | Charite University Ethics Comission |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS Stimulation of dlPFC | Active Comparator | Medical device: tDCS Stimulation over left dorsolateral prefrontal cortex (DLPFC) for 20 min daily over 5 consecutive days |
|
| Sham Stimulation of dlPFC | Sham Comparator | Medical device: Placebo Sham stimulation over left dorsolateral prefrontal cortex (dlPFC) for 20 min daily over 5 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS of dlPFC | Device | Transcranial direct current stimulation over left dorsolateral prefrontal cortex (DLPFC) for 20 min daily over 5 consecutive days at 1200 uA |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At enrolment and 4 days, two weeks and four weeks after enrolment |
| Neurobehavioral markers of effort discounting | Measured in a functional MRI (fMRI) task | At enrolment and 4 days after enrolment |
| Neurobehavioral markers of habit formation | Measured in an fMRI task | At enrolment and 4 days after enrolment |
| White matter integrity MRI measure | Computed as voxel-wise quotients of T1-weighted and T2-weigted anatomical MRI brain scan parameters | At enrolment and 4 days after enrolment |
| Brain age marker | Inferred via machine learning from anatomical T1-weighted brain scan | At enrolment and 4 days after enrolment |
| Whole-brain grey matter fraction | Inferred from anatomical T1-weighted brain MRI scans | At enrolment and 4 days after enrolment |
| Whole-brain volume of focal brain lesions | Inferred from anatomical T2-weighted brain MRI scans | At enrolment and 4 days after enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in concentration of inflammatory markers | 124 blood-derived inflammatory cytokine and chemokine markers determined via an inflammatory panel | At enrolment and 4 days after enrolment |
| Change in cognitive performance |
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Inclusion Criteria:
Men and women
Exclusion Criteria:
• MRI contraindications
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janina Dr. Behrens, Dr. med. | Contact | +49 30 7560921 | janina.behrens@charite.de | |
| Martin Dr. Weygandt, PhD | Contact | martin.weygandt@mdc-berlin.de |
| Name | Affiliation | Role |
|---|---|---|
| Chotima Dr. Böttcher, PhD | Max-Delbrück-Centrum Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Campus Mitte | Recruiting | Berlin | State of Berlin | 10117 | Germany |
Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
Beginning three years after project end
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Sham Stimulation of dlPFC | Device | Sham Stimulation of the dlPFC via tDCS device for 20 minutes on 5 consecutive days |
|
Brief International Cognitive Assessment for MS (BICAMS)
| At enrolment and 4 days after enrolment |
| Complementary fatigue markers | Fatigue Severity Scale (FSS), Minimum value 7, Maximum value 63, higher score denoting a worse outcome. | At enrolment, and 4 days, two and four weeks after enrolment |
| Severity of depressive symptoms | Beck Depression Inventory (BDI-II), Minimum value 0, Maximum value 63, higher values denoting worse outcome | At enrolment and 4 days after enrolment |
| Sleep quality | Pittsburgh Sleep Quality Index (PSQI), Minimum Score 0, Maximum Score 21, higher score denoting worse outcome | At enrolment and 4 days after enrolment |
| Severity of anxiety symptoms | Measured on the State-Trait Anxiety index-I (STAI-I), minimum score 20, maximum score 80, higher score denoting worse outcome | At enrolment and 4 days after enrolment |
| Change in Fatigue severity | Visual analogue scale of fatigue (VAS-F), minimum value 1, maximum value 10, higher score denoting worse outcome | At enrolment, and 1,2,3,4 days, two and four weeks after enrolment |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |