Transcranial Electrical Stimulation in Multiple Sclerosis

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Cerebral blood flow (CBF) [Срок оценки: Visit 1 (baseline), visit 2 (+-1 week after visit 1), visit 3 (2 years after visit 1)]

Вторичные конечные точки (8)

• Symbol Digit Modalities Test (SDMT) [Срок оценки: Baseline and after 2 years]
• California Verbal Learning Test (CVLT-II) [Срок оценки: Baseline and after 2 years]
• Controlled Oral Word Association Test (COWAT) [Срок оценки: Baseline and after 2 years]
• Brief visuospatial Memory Test (BVMT-R) [Срок оценки: Baseline and after 2 years]
• Fatigue Scale for Motor and Cognitive Function (FSMC) [Срок оценки: Baseline and after 2 years]
• Beck's depression inventory (BDI) [Срок оценки: Baseline and after 2 years]
• MRI T1 scan [Срок оценки: Baseline and after 2 years]
• MRI T2 FLAIR scan [Срок оценки: Baseline and after 2 years]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Бельгия · 2 центра

• University hospital of Brussels — Brussels
• National MS Center Melsbroek — Melsbroek

Идентификаторы

NCT: NCT06966128 · 24378_TEMS · FWOAL1107

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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