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临床试验/NCT02481882
NCT02481882Unknown不适用

Investigating Baseline Cortical Haemodynamics in Multiple Sclerosis

University of Nottingham1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Cerebral Blood Flow

研究概览

简要总结

This study will provide information on cortical haemodynamics in MS patients to address the discrepancies reported in previous literature, allowing further insight into the role of haemodynamics in the disease. It will also instruct us as to the most effective scanning protocols for future research. Developing a suitable protocol for studying perfusion longitudinally may also enable identification of new therapeutic interventions to normalise any perfusion abnormalities in MS patients.

详细描述

We aim to characterise the underlying cortical haemodynamics in Multiple Sclerosis (MS). We will assess two techniques for measuring blood flow in the brain: arterial spin labelling (ASL) and dynamic susceptibility contrast (DSC) magnetic resonance imaging in the MS patient group. ASL is a non-invasive technique whilst DSC-MR requires the administration of a tracer intravenously. Previous studies have shown conflicting results from these measurements. Reproducibility of ASL and disease activity will also be assessed through repeated scan sessions. Global perfusion in the MS patient group will be compared to a matched healthy control group.

In addition to measuring blood flow using both methods, we will investigate whether differences in perfusion between the MS patient group and the healthy controls can be observed using ASL, and also assess the reproducibility of ASL measurements via repeated scans. These repeated scanning sessions also provide a window to study disease activity in the patient cohort, and patients may be invited to return for up to a total of 4 scanning sessions (with only one involving the use of DSC) to better assess the usefulness of ASL in tracking haemodynamic changes in MS.

Study Regimen:

We aim to recruit 20 MS patients and 20 healthy age-matched controls for this study.

MS Patient Cohort:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Any history of neurological illness other than MS.
  • Known hypersensitivity to any MR or X-Ray contrast agent.
  • Any history of renal failure or disease.
  • Any history of allergies.
  • Any history of circulation problems (vascular disease).
  • Pregnancy or breastfeeding.
  • MRI contraindications as screened on safety questionnaire (e.g. metal implants or pacemaker).
  • Have taken part in any other clinical study within the previous 3 months.#
  • Any contraindications provided from MRI or contrast agent safety forms.

研究组 & 干预措施

Healthy Volunteers

Other

Healthy Volunteers will undergo an Magnetic Resonance Imaging scan.

干预措施: Magnetic Resonance Imaging (Device)

MS Patients

Other

Patients will undergo and Magnetic Resonance Imaging scan including the use of Prohance (Gadoteridol).

干预措施: Magnetic Resonance Imaging (Device)

MS Patients

Other

Patients will undergo and Magnetic Resonance Imaging scan including the use of Prohance (Gadoteridol).

干预措施: Prohance (Gadoteridol) (Drug)

结局指标

主要结局

Cerebral Blood Flow

时间窗: 1 hour

A short MRI scan is able to quantify the amount of blood perfusion into brain tissue (to be performed with and without the gadolinium contrast agent).

次要结局

  • Arterial Cerebral Blood Volume(1 hour)
  • Arterial Transit Time(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Baseline Cortical Haemodynamics in MS | 临床试验