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ClinicalTrials.gov ID

NCT06966128

Lead Sponsor

Universitair Ziekenhuis BrusselOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

100Estimated

Last Update Posted

May 29, 2025Actual

Start Date

Jun 1, 2025Estimated

Primary Completion Date

Jan 1, 2029Estimated

Completion Date

Jan 1, 2029Estimated

Official Title

The Effect of Transcranial Direct Current Stimulation on Cerebral Blood Flow in Patients With Multiple Sclerosis

Brief 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.

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.

• Multiple Sclerosis

• transcranial Direct Current Stimulation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion criteria - MS patient

• EDSS ≥ 2 and EDSS ≤ 6.5
• Age ≥ 18

Exclusion criteria - MS patient

• 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

Inclusion criteria - Healthy Volunteer

• Age ≥ 18

Exclusion criteria - Healthy Volunteer

• Incompatibility with MRI
• Disabling concomitant neuropsychiatric diseases
• Chance of pregnancy, breastfeeding
• Contraindications to tDCS

Primary Purpose

Basic Science

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

Triple

Lead Sponsor

Universitair Ziekenhuis BrusselOTHER

Collaborators

Fund for Scientific Research, Flanders, BelgiumOTHER

Vrije Universiteit BrusselOTHER

kristien.cool@vub.be+32 468 54 53 98