RECRUITINGINTERVENTIONAL

Non-invasive Brain Stimulation in Multiple Sclerosis Fatigue

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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" Who Should NOT Join This Trial: - • 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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