Transcranial Electrical Stimulation in Multiple Sclerosis (TEMS)

Universitair Ziekenhuis Brussel

Status: Not yet enrolling

Conditions: Multiple Sclerosis

Treatments: Device: transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06966128

FWOAL1107 (Other Grant/Funding Number)

24378_TEMS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Sham-first tDCS

Other group

Description:

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

Treatment:

Device: transcranial Direct Current Stimulation

Active-first tDCS

Other group

Description:

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

Treatment:

Device: transcranial Direct Current Stimulation