New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis
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
- 是
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
干预措施: Muscular MRI (Other)
Muscle
干预措施: Electrophysiological exam (Other)
Spinal cord
干预措施: Muscular MRI (Other)
Spinal cord
干预措施: Electrophysiological exam (Other)
Spinal cord
干预措施: Spinal cord MRI (Other)
Brain
干预措施: Muscular MRI (Other)
Brain
干预措施: Electrophysiological exam (Other)
Brain
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)