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临床试验/NCT04691011
NCT04691011已完成不适用

New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年6月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Disease progression using MRI

研究概览

简要总结

Amyotrophic lateral sclerosis (ALS) is a disabling and rapidly progressive neurodegenerative disorder. There is no treatment that significantly slows progression. Our project aims to find new biomarkers in MRI at three levels: cerebral, medullary and muscular. These markers could allow an earlier diagnosis of the disease by showing more specific lesions of ALS and to quantify these lesions to measure the progression of the disease. This study will use advanced Magnetic Resonance Imaging (MRI) techniques High field (3T) and very high field (7T) MRI. Results from neurological and electrophysiological tests will be compared to the MRI. Subjects will be recruited from ALS center of Marseille, France. MRI will be done on ALS patients at baseline, at 3 month and at 6 month intervals.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Patients will be adults with a diagnosis of ALS.
  • Healthy controls will also be recruited and will be age- and gender-matched to patients.
  • Patients able to undergo a brain MRI for approximately an hour.

排除标准

  • Subjects with other psychiatric or CNS or PNS diseases.
  • Subjects ineligible for MRI investigation due to a pacemaker or other metallic foreign body, or significant claustrophobia that could affect the ability to have an MRI scan.

研究组 & 干预措施

Muscle

Other

干预措施: Muscular MRI (Other)

Muscle

Other

干预措施: Electrophysiological exam (Other)

Spinal cord

Other

干预措施: Muscular MRI (Other)

Spinal cord

Other

干预措施: Electrophysiological exam (Other)

Spinal cord

Other

干预措施: Spinal cord MRI (Other)

Brain

Other

干预措施: Muscular MRI (Other)

Brain

Other

干预措施: Electrophysiological exam (Other)

Brain

Other

干预措施: Brain MRI (Other)

结局指标

主要结局

Disease progression using MRI

时间窗: Change from Baseline and at Month 6

Muscular, brain and spinal cord MRI (brain sodium concentration, muscular volume of members, measure of transversal area for spinal cord)

次要结局

  • Alterations of metabolic and funtional brain(Baseline and Month 6)
  • Link between MRI and clinical scales(Baseline and Month 6)
  • Link between MRI and MUNIX(Baseline and Month 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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