Transcranial Electrical Stimulation in Multiple Sclerosis
NCT ID: NCT06966128
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-06-01
2029-01-01
Brief Summary
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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.
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Detailed Description
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\- 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
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Sham-first tDCS
The sham-first group will receive: Sham stimulation in visit 1, Active stimulation in visit 2
transcranial Direct Current Stimulation
Stimulation intensity: Variable (between 1 mA and 2 mA), Electrode placement: Dorsolateral prefrontal cortex, Duration: 10 minutes
Active-first tDCS
The active-first group will receive: Active stimulation in visit 1, Sham stimulation in visit 2
transcranial Direct Current Stimulation
Stimulation intensity: Variable (between 1 mA and 2 mA), Electrode placement: Dorsolateral prefrontal cortex, Duration: 10 minutes
Interventions
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transcranial Direct Current Stimulation
Stimulation intensity: Variable (between 1 mA and 2 mA), Electrode placement: Dorsolateral prefrontal cortex, Duration: 10 minutes
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18
• Age ≥ 18
Exclusion Criteria
* 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
* Incompatibility with MRI
* Disabling concomitant neuropsychiatric diseases
* Chance of pregnancy, breastfeeding
* Contraindications to tDCS
18 Years
ALL
Yes
Sponsors
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Fund for Scientific Research, Flanders, Belgium
OTHER
Vrije Universiteit Brussel
OTHER
Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Locations
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University hospital of Brussels
Brussels, , Belgium
National MS Center Melsbroek
Melsbroek, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FWOAL1107
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
24378_TEMS
Identifier Type: -
Identifier Source: org_study_id
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