The Effect of Transcranial Direct Current Stimulation on Cerebral Blood Flow in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Cerebral blood flow (CBF)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •MS patient
- •EDSS ≥ 2 and EDSS ≤ 6.5
排除标准
- •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
- •Exclusion criteria - Healthy Volunteer
- •Incompatibility with MRI
- •Disabling concomitant neuropsychiatric diseases
- •Chance of pregnancy, breastfeeding
- •Contraindications to tDCS
研究组 & 干预措施
Sham-first tDCS
The sham-first group will receive: Sham stimulation in visit 1, Active stimulation in visit 2
干预措施: transcranial Direct Current Stimulation (Device)
Active-first tDCS
The active-first group will receive: Active stimulation in visit 1, Sham stimulation in visit 2
干预措施: transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Cerebral blood flow (CBF)
时间窗: 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.
次要结局
- 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)
- Beck's depression inventory (BDI)(Baseline and after 2 years)
- MRI T1 scan(Baseline and after 2 years)
- MRI T2 FLAIR scan(Baseline and after 2 years)