Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Cerebral hemodynamics, Cerebral circulation, Cerebral hypoperfusion, Transcranial Direct Current Stimulation, Electrical stimulation
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.
Interventions
DEVICEtranscranial Direct Current Stimulation
Stimulation intensity: Variable (between 1 mA and 2 mA), Electrode placement: Dorsolateral prefrontal cortex, Duration: 10 minutes
Sponsors
Fund for Scientific Research, Flanders, Belgium
Vrije Universiteit Brussel
Universitair Ziekenhuis Brussel
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral blood flow (CBF) | 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
| Measure | Time frame | Description |
|---|---|---|
| California Verbal Learning Test (CVLT-II) | Baseline and after 2 years | Measure of verbal memory |
| Controlled Oral Word Association Test (COWAT) | Baseline and after 2 years | Measure of verbal fluency |
| Brief visuospatial Memory Test (BVMT-R) | Baseline and after 2 years | Measure of spatial memory |
| Symbol Digit Modalities Test (SDMT) | Baseline and after 2 years | Measure of information processing speed |
| Beck's depression inventory (BDI) | Baseline and after 2 years | Measure of depression |
| MRI T1 scan | Baseline and after 2 years | Cortical volume, volumes of white matter and deep grey matter |
| MRI T2 FLAIR scan | Baseline and after 2 years | Lesion load, lesion volume |
| Fatigue Scale for Motor and Cognitive Function (FSMC) | Baseline and after 2 years | Measure of fatigue |
Countries
Belgium
Contacts
Primary ContactKristien Cool, Master in Biomedical Sciences
Outcome results
None listed