Transcranial Electrical Stimulation in Multiple Sclerosis

NCT ID: NCT06966128

Last Updated: 2025-05-29

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2029-01-01

Brief Summary

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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

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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

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Group Type OTHER

transcranial Direct Current Stimulation

Intervention Type DEVICE

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

Group Type OTHER

transcranial Direct Current Stimulation

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* EDSS ≥ 2 and EDSS ≤ 6.5
* Age ≥ 18


• Age ≥ 18

Exclusion Criteria

* 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


* Incompatibility with MRI
* Disabling concomitant neuropsychiatric diseases
* Chance of pregnancy, breastfeeding
* Contraindications to tDCS
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University hospital of Brussels

Brussels, , Belgium

Site Status

National MS Center Melsbroek

Melsbroek, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Kristien Cool, Master in Biomedical Sciences

Role: CONTACT

+32468545398

Facility Contacts

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Kristien Cool

Role: primary

+32 468 54 53 98

Miguel D'Haeseleer

Role: backup

Kristien Cool

Role: primary

+32 468 54 53 98

Miguel D'Haeseleer

Role: backup

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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