Multiple SclerosisNCT07438964
Non-invasive Brain Stimulation in Multiple Sclerosis Fatigue
A study testing tDCS of dlPFC in people with Multiple Sclerosis and Fatigue in Multiple Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Fatigue in Multiple Sclerosis
- What is being tested?
- tDCS of dlPFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- 2 Mar 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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 cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Martin Dr. Weygandt, PhD contact
Germany1 site, 1 recruiting
- Recruiting
Charité Campus Mitte
Berlin, State of Berlin, 10117
Janina Dr. Behrens, MD, +49 30 7560921, janina.behrens@charite.de
Zoe J Mossmann, MD/PhD
About this study
Official title: Non-invasive Brain Stimulation for Altering Neuro-inflammatory Mediators of Central Fatigue in Multiple Sclerosis
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.
Read more
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.
- Conditions
- Multiple Sclerosis, Fatigue in Multiple Sclerosis
- Being tested
- tDCS of dlPFC, Sham Stimulation of dlPFC
- Keywords
- Transcranial direct current stimulation, Fatigue, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS of dlPFCDevice
Transcranial direct current stimulation over left dorsolateral prefrontal cortex (DLPFC) for 20 min daily over 5 consecutive days at 1200 uA
Sham Stimulation of dlPFCDevice
Sham Stimulation of the dlPFC via tDCS device for 20 minutes on 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| tDCS Stimulation of dlPFC | Active comparator | Medical device: tDCS Stimulation over left dorsolateral prefrontal cortex (DLPFC) for 20 min daily over 5 consecutive days Receives: Device: tDCS of dlPFC |
| 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 Receives: Device: Sham Stimulation of dlPFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At enrolment and 4 days, two weeks and four weeks after enrolment
Neurobehavioral markers of effort discounting
Measured in a functional MRI (fMRI) task
Measured: At enrolment and 4 days after enrolment
Neurobehavioral markers of habit formation
Measured in an fMRI task
Measured: 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
Measured: At enrolment and 4 days after enrolment
Brain age marker
Inferred via machine learning from anatomical T1-weighted brain scan
Measured: At enrolment and 4 days after enrolment
Whole-brain grey matter fraction
Inferred from anatomical T1-weighted brain MRI scans
Measured: At enrolment and 4 days after enrolment
Whole-brain volume of focal brain lesions
Inferred from anatomical T2-weighted brain MRI scans
Measured: At enrolment and 4 days after enrolment
Secondary outcomes (7)
Change in concentration of inflammatory markers
124 blood-derived inflammatory cytokine and chemokine markers determined via an inflammatory panel
Measured: At enrolment and 4 days after enrolment
Change in cognitive performance
Brief International Cognitive Assessment for MS (BICAMS)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At enrolment, and 1,2,3,4 days, two and four weeks after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start2 Mar 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janina Behrens, Charite University, Berlin, Germany
- Investigators
- Chotima Dr. Böttcher, PhD, Principal investigator, Max-Delbrück-Centrum Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438964
- Sponsor's protocol ID
- FAMS-DFG
- Other IDs
- EA4/044/25
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Brain Stimulation for Altering Neuro-inflammatory Mediators of Central Fatigue in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07438964
- Acronym / sponsor ID
- FAMS-DFG
- Conditions
- Multiple Sclerosis, Fatigue in Multiple Sclerosis
- Keywords
- Transcranial direct current stimulation, Fatigue, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS Stimulation of dlPFC | Active comparator | Device: tDCS of dlPFCMedical device: tDCS Stimulation over left dorsolateral prefrontal cortex (DLPFC) for 20 min daily over 5 consecutive days |
| Sham Stimulation of dlPFC | Sham comparator | Device: Sham Stimulation of dlPFCMedical device: Placebo Sham stimulation over left dorsolateral prefrontal cortex (dlPFC) for 20 min daily over 5 consecutive days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women
Key exclusion criteria (6 listed)
- • MRI contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS of dlPFCTranscranial direct current stimulation over left dorsolateral prefrontal cortex (DLPFC) for 20 min daily over 5 consecutive days at 1200 uA | Device | tDCS Stimulation of dlPFC |
| Sham Stimulation of dlPFCSham Stimulation of the dlPFC via tDCS device for 20 minutes on 5 consecutive days | Device | Sham Stimulation of dlPFC |
Primary outcome
Central fatigue
Time frame: 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
Time frame: At enrolment and 4 days after enrolment
Measured in a functional MRI (fMRI) task
Neurobehavioral markers of habit formation
Time frame: At enrolment and 4 days after enrolment
Measured in an fMRI task
White matter integrity MRI measure
Time frame: 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
Time frame: At enrolment and 4 days after enrolment
Inferred via machine learning from anatomical T1-weighted brain scan
Whole-brain grey matter fraction
Time frame: At enrolment and 4 days after enrolment
Inferred from anatomical T1-weighted brain MRI scans
Whole-brain volume of focal brain lesions
Time frame: At enrolment and 4 days after enrolment
Inferred from anatomical T2-weighted brain MRI scans
7 secondary outcomes
Change in concentration of inflammatory markers
Time frame: At enrolment and 4 days after enrolment
Change in cognitive performance
Time frame: At enrolment and 4 days after enrolment
Complementary fatigue markers
Time frame: At enrolment, and 4 days, two and four weeks after enrolment
Severity of depressive symptoms
Time frame: At enrolment and 4 days after enrolment
Sleep quality
Time frame: At enrolment and 4 days after enrolment
Severity of anxiety symptoms
Time frame: At enrolment and 4 days after enrolment
Change in Fatigue severity
Time frame: At enrolment, and 1,2,3,4 days, two and four weeks after enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Dr. Weygandt, PhD contact
Chotima Dr. Böttcher, PhD principal investigator
Max-Delbrück-Centrum Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS of dlPFC in people with Multiple Sclerosis and Fatigue in Multiple Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janina Dr. Behrens, Dr. med. (+49 30 7560921, janina.behrens@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central fatigue (time frame: At enrolment and 4 days, two weeks and four weeks after enrolment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.