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NCT Number: NCT06966128

Transcranial Electrical Stimulation in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of Brussels, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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

Primary outcomes

  1. Cerebral blood flow (CBF)

    Time frame: 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 outcomes

  1. Symbol Digit Modalities Test (SDMT)

    Time frame: Baseline and after 2 years

    Measure of information processing speed

  2. California Verbal Learning Test (CVLT-II)

    Time frame: Baseline and after 2 years

    Measure of verbal memory

  3. Controlled Oral Word Association Test (COWAT)

    Time frame: Baseline and after 2 years

    Measure of verbal fluency

  4. Brief visuospatial Memory Test (BVMT-R)

    Time frame: Baseline and after 2 years

    Measure of spatial memory

  5. Fatigue Scale for Motor and Cognitive Function (FSMC)

    Time frame: Baseline and after 2 years

    Measure of fatigue

  6. Beck's depression inventory (BDI)

    Time frame: Baseline and after 2 years

    Measure of depression

  7. MRI T1 scan

    Time frame: Baseline and after 2 years

    Cortical volume, volumes of white matter and deep grey matter

  8. MRI T2 FLAIR scan

    Time frame: Baseline and after 2 years

    Lesion load, lesion volume

Study contacts

Contact information is provided by the study sponsor or research team.

Kristien Cool, Master in Biomedical Sciences

CONTACT

[email protected]

+32468545398

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Collaborators

  • Fund for Scientific Research, Flanders, Belgium
  • Vrije Universiteit Brussel

Registry information

Official study title

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

Acronym: TEMS

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 11, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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