NCT06966128

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
33mo left

Started Jun 2025

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jun 2025Jan 2029

First Submitted

Initial submission to the registry

January 6, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

3.6 years

First QC Date

January 6, 2025

Last Update Submit

May 22, 2025

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisCerebral hemodynamicsCerebral circulationCerebral hypoperfusionTranscranial Direct Current StimulationElectrical stimulation

Outcome Measures

Primary Outcomes (1)

  • Cerebral blood flow (CBF)

    Measure of brain perfusion. CBF is measured at baseline and after two years. Additionally, the investigators will measure CBF before-, during-, and after tDCS.

    Visit 1 (baseline), visit 2 (+-1 week after visit 1), visit 3 (2 years after visit 1)

Secondary Outcomes (8)

  • Symbol Digit Modalities Test (SDMT)

    Baseline and after 2 years

  • California Verbal Learning Test (CVLT-II)

    Baseline and after 2 years

  • Controlled Oral Word Association Test (COWAT)

    Baseline and after 2 years

  • Brief visuospatial Memory Test (BVMT-R)

    Baseline and after 2 years

  • Fatigue Scale for Motor and Cognitive Function (FSMC)

    Baseline and after 2 years

  • +3 more secondary outcomes

Study Arms (2)

Sham-first tDCS

OTHER

The sham-first group will receive: Sham stimulation in visit 1, Active stimulation in visit 2

Device: transcranial Direct Current Stimulation

Active-first tDCS

OTHER

The active-first group will receive: Active stimulation in visit 1, Sham stimulation in visit 2

Device: transcranial Direct Current Stimulation

Interventions

transcranial Direct Current StimulationDEVICE

Stimulation intensity: Variable (between 1 mA and 2 mA), Electrode placement: Dorsolateral prefrontal cortex, Duration: 10 minutes

Active-first tDCSSham-first tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • EDSS ≥ 2 and EDSS ≤ 6.5
  • Age ≥ 18

You may not qualify if:

  • 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
  • Age ≥ 18
  • Incompatibility with MRI
  • Disabling concomitant neuropsychiatric diseases
  • Chance of pregnancy, breastfeeding
  • Contraindications to tDCS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University hospital of Brussels

Brussels, 1090, Belgium

Location

National MS Center Melsbroek

Melsbroek, 1820, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Central Study Contacts

Kristien Cool, Master in Biomedical Sciences

CONTACT

+32468545398kristien.cool@vub.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2025

First Posted

May 11, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

We will not share individual participant data. As we collect personal data on people with multiple sclerosis, we share data on request and after signing a data sharing agreement between both parties. This ensures proper usage and interpretation of the results.

Locations

BE(2)