Transcranial Electrical Stimulation in Multiple Sclerosis

Not Applicable

Not yet recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT06966128
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Study First Submitted: 2025-01-06
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-02
• Study First Posted: 2025-05-11
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-29
• Study Start: 2025-06-01
• Primary Completion: 2029-01-01
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Cerebral blood flow (CBF)	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.

Secondary Outcome Measures

Name	Time	Method
Symbol Digit Modalities Test (SDMT)	Baseline and after 2 years	Measure of information processing speed
California Verbal Learning Test (CVLT-II)	Baseline and after 2 years	Measure of verbal memory
Controlled Oral Word Association Test (COWAT)	Baseline and after 2 years	Measure of verbal fluency
Brief visuospatial Memory Test (BVMT-R)	Baseline and after 2 years	Measure of spatial memory
Fatigue Scale for Motor and Cognitive Function (FSMC)	Baseline and after 2 years	Measure of fatigue
Beck's depression inventory (BDI)	Baseline and after 2 years	Measure of depression
MRI T1 scan	Baseline and after 2 years	Cortical volume, volumes of white matter and deep grey matter
MRI T2 FLAIR scan	Baseline and after 2 years	Lesion load, lesion volume

Trial Locations

Locations (2)

University hospital of Brussels; 🇧🇪 Brussels, Belgium

National MS Center Melsbroek; 🇧🇪 Melsbroek, Belgium