Clinical trial NCT06966128: Transcranial Electrical Stimulation in Multiple Sclerosis
Official title: The Effect of Transcranial Direct Current Stimulation on Cerebral Blood Flow in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Cerebral hemodynamics
Cerebral circulation
Cerebral hypoperfusion
Transcranial Direct Current Stimulation
Electrical stimulation
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
name: Vrije Universiteit Brussel
First posted: 2025-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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 outcomes:
measure: Cerebral blood flow (CBF)
timeFrame: Visit 1 (baseline), visit 2 (+-1 week after visit 1), visit 3 (2 years after visit 1)
Secondary outcomes:
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline and after 2 years
measure: California Verbal Learning Test (CVLT-II)
timeFrame: Baseline and after 2 years
measure: Controlled Oral Word Association Test (COWAT)
timeFrame: Baseline and after 2 years
measure: Brief visuospatial Memory Test (BVMT-R)
timeFrame: Baseline and after 2 years
measure: Fatigue Scale for Motor and Cognitive Function (FSMC)
timeFrame: Baseline and after 2 years
measure: Beck's depression inventory (BDI)
timeFrame: Baseline and after 2 years
measure: MRI T1 scan
timeFrame: Baseline and after 2 years
measure: MRI T2 FLAIR scan
timeFrame: Baseline and after 2 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: University hospital of Brussels
city: Melsbroek
country: Belgium
facility: National MS Center Melsbroek
Study officials:
References: