Multiple SclerosisTEMSNCT06966128
Transcranial Electrical Stimulation in Multiple Sclerosis
A study testing transcranial Direct Current Stimulation in people with Multiple Sclerosis, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
Trial summary
First the investigators will examine if the blood flow in the brain is different in patients with Multiple Sclerosis compared to healthy volunteers. HOW? The blood flow of the subjects is imaged by use of a special MRI-technique. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Jun 2025to 1 Jan 2029
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- EDSS ≥ 2 and EDSS ≤ 6.5
- Age ≥ 18
- Age ≥ 18
Who cannot join
- EDSS > 6.5
- Incompatibility with MRI
- Relapse within three months before the study and its use of corticosteroids
- Disabling concomitant neuropsychiatric diseases
- Chance of pregnancy, breastfeeding
- Contraindications to tDCS
Show all 10Show fewer
- Incompatibility with MRI
- Disabling concomitant neuropsychiatric diseases
- Chance of pregnancy, breastfeeding
- Contraindications to tDCS
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites
University hospital of Brussels
Brussels, 1090
Kristien Cool, +32 468 54 53 98, kristien.cool@vub.be
Miguel D'Haeseleer, miguel.dhaeseleer@mscenter.be
National MS Center Melsbroek
Melsbroek, 1820
Kristien Cool, +32 468 54 53 98, kristien.cool@vub.be
Miguel D'Haeseleer, miguel.dhaeseleer@mscenter.be
About this study
Official title: The Effect of Transcranial Direct Current Stimulation on Cerebral Blood Flow in Patients With Multiple Sclerosis
First the investigators will examine if the blood flow in the brain is different in patients with Multiple Sclerosis compared to healthy volunteers.
HOW?
Read more
- The blood flow of the subjects is imaged by use of a special MRI-technique.
Secondly, the investigators will examine if the blood flow can determine disease progression.
HOW? - Multiple Sclerosis patients are asked for a follow-up visit after two years.
The main goal is to understand the effect of transcranial Direct Current Stimulation (tDCS) on the cerebral blood flow.
- Does tDCS result in a different blood flow, in which brain regions?
- Is there a difference between healthy volunteers and Multiple Sclerosis patients?
HOW?
- Participants get two session of tDCS. Before, during and after stimulation MRI scans are performed.
Read the detailed description
Comparison of CBF between healthy volunteers and MS patients:
- Arterial spin labelling (ASL) is used to investigate cerebral blood flow in patients with MS and healthy volunteers.
The effect of transcranial direct current stimulation (tDCS) on cerebral blood flow:
- ASL scans are performed before-, during-, and after tDCS
- Each subject will receive active and sham tDCS (seperated by at least two days) (cross-over design).
Follow-up visit:
- After two years, patients with MS are re-invited.
- This visit will include a new neuropsychological evaluation, blood sampling and additional brain scans.
- Conditions
- Multiple Sclerosis
- Being tested
- transcranial Direct Current Stimulation
- Keywords
- Multiple Sclerosis, Cerebral hemodynamics, Cerebral circulation, Cerebral hypoperfusion, Transcranial Direct Current Stimulation, Electrical stimulation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Direct Current StimulationDevice
Stimulation intensity: Variable (between 1 mA and 2 mA), Electrode placement: Dorsolateral prefrontal cortex, Duration: 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Sham-first tDCS | Other | The sham-first group will receive: Sham stimulation in visit 1, Active stimulation in visit 2 Receives: Device: transcranial Direct Current Stimulation |
| Active-first tDCS | Other | The active-first group will receive: Active stimulation in visit 1, Sham stimulation in visit 2 Receives: Device: transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow (CBF)
Measure of brain perfusion.
CBF is measured at baseline and after two years. Additionally, the investigators will measure CBF before-, during-, and after tDCS.
Measured: Visit 1 (baseline), visit 2 (+-1 week after visit 1), visit 3 (2 years after visit 1)
Secondary outcomes (8)
Symbol Digit Modalities Test (SDMT)
Measure of information processing speed
Measured: Baseline and after 2 years
California Verbal Learning Test (CVLT-II)
Measure of verbal memory
Measured: Baseline and after 2 years
Controlled Oral Word Association Test (COWAT)
Measure of verbal fluency
Measured: Baseline and after 2 years
Brief visuospatial Memory Test (BVMT-R)
Measure of spatial memory
Measured: Baseline and after 2 years
Fatigue Scale for Motor and Cognitive Function (FSMC)
Measure of fatigue
Measured: Baseline and after 2 years
Beck's depression inventory (BDI)
Measure of depression
Measured: Baseline and after 2 years
MRI T1 scan
Cortical volume, volumes of white matter and deep grey matter
Measured: Baseline and after 2 years
MRI T2 FLAIR scan
Lesion load, lesion volume
Measured: Baseline and after 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, Vrije Universiteit Brussel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966128
- Sponsor's protocol ID
- 24378_TEMS
- Other IDs
- FWOAL1107
- Acronym
- TEMS
- Status last verified
- May 2025
- First submitted
- 6 Jan 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We will not share individual participant data. As we collect personal data on people with multiple sclerosis, we share data on request and after signing a data sharing agreement between both parties. This ensures proper usage and interpretation of the results.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Direct Current Stimulation on Cerebral Blood Flow in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06966128
- Acronym / sponsor ID
- TEMS / 24378_TEMS
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Cerebral hemodynamics, Cerebral circulation, Cerebral hypoperfusion, Transcranial Direct Current Stimulation, Electrical stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, Vrije Universiteit Brussel
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 11 May 2025 (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.
First the investigators will examine if the blood flow in the brain is different in patients with Multiple Sclerosis compared to healthy volunteers.
HOW?
- The blood flow of the subjects is imaged by use of a special MRI-technique.
Secondly, the investigators will examine if the blood flow can determine disease progression.
HOW? - Multiple Sclerosis patients are asked for a follow-up visit after two years.
The main goal is to understand the effect of transcranial Direct Current Stimulation (tDCS) on the cerebral blood flow.
- Does tDCS result in a different blood flow, in which brain regions?
- Is there a difference between healthy volunteers and Multiple Sclerosis patients?
HOW?
- Participants get two session of tDCS. Before, during and after stimulation MRI scans are performed.
Detailed description
Comparison of CBF between healthy volunteers and MS patients:
- Arterial spin labelling (ASL) is used to investigate cerebral blood flow in patients with MS and healthy volunteers.
The effect of transcranial direct current stimulation (tDCS) on cerebral blood flow:
- ASL scans are performed before-, during-, and after tDCS
- Each subject will receive active and sham tDCS (seperated by at least two days) (cross-over design).
Follow-up visit:
- After two years, patients with MS are re-invited.
- This visit will include a new neuropsychological evaluation, blood sampling and additional brain scans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham-first tDCS | Other | Device: transcranial Direct Current StimulationThe sham-first group will receive: Sham stimulation in visit 1, Active stimulation in visit 2 |
| Active-first tDCS | Other | Device: transcranial Direct Current StimulationThe active-first group will receive: Active stimulation in visit 1, Sham stimulation in visit 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- EDSS ≥ 2 and EDSS ≤ 6.5
- Age ≥ 18
- Age ≥ 18
Key exclusion criteria (10 listed)
- EDSS > 6.5
- Incompatibility with MRI
- Relapse within three months before the study and its use of corticosteroids
- Disabling concomitant neuropsychiatric diseases
- Chance of pregnancy, breastfeeding
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 |
|---|---|---|
| transcranial Direct Current StimulationStimulation intensity: Variable (between 1 mA and 2 mA), Electrode placement: Dorsolateral prefrontal cortex, Duration: 10 minutes | Device | Active-first tDCS, Sham-first tDCS |
Primary outcome
Cerebral blood flow (CBF)
Time frame: Visit 1 (baseline), visit 2 (+-1 week after visit 1), visit 3 (2 years after visit 1)
Measure of brain perfusion. CBF is measured at baseline and after two years. Additionally, the investigators will measure CBF before-, during-, and after tDCS.
8 secondary outcomes
Symbol Digit Modalities Test (SDMT)
Time frame: Baseline and after 2 years
California Verbal Learning Test (CVLT-II)
Time frame: Baseline and after 2 years
Controlled Oral Word Association Test (COWAT)
Time frame: Baseline and after 2 years
Brief visuospatial Memory Test (BVMT-R)
Time frame: Baseline and after 2 years
Fatigue Scale for Motor and Cognitive Function (FSMC)
Time frame: Baseline and after 2 years
Beck's depression inventory (BDI)
Time frame: Baseline and after 2 years
MRI T1 scan
Time frame: Baseline and after 2 years
MRI T2 FLAIR scan
Time frame: Baseline and after 2 years
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 29 May 2025.
- Individual participant dataSharing planned: No. We will not share individual participant data. As we collect personal data on people with multiple sclerosis, we share data on request and after signing a data sharing agreement between both parties. This ensures proper usage and interpretation of the results.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Direct Current Stimulation in people with Multiple Sclerosis, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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. 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 Kristien Cool, Master in Biomedical Sciences (+32468545398, kristien.cool@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow (CBF) (time frame: Visit 1 (baseline), visit 2 (+-1 week after visit 1), visit 3 (2 years after visit 1)). 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 29 May 2025.