Spinal Cord Gray and White Matter Imaging in Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Spinal Cord Gray Matter 18 month follow-up
研究概览
简要总结
This study aims to measure in vivo the spinal cord gray and white matter in patients with Amyotrophic Lateral Sclerosis and healthy persons that match the patients' age and sex using rAMIRA imaging, a novel Magnetic Resonance Imaging (MRI) method. Patients and healthy control persons prospectively undergo MRI examinations, clinical examinations including assessments of disability, and tests of muscle force using hand held dynamometry. Serum markers of neuro-axonal injury are also assessed.
Examinations for patients and healthy control persons are scheduled every six months over a time span of two years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Spinal Cord Gray Matter 18 month follow-up
时间窗: 18 month follow-up
Spinal cord gray matter cross-sectional area in mm2
Spinal Cord Gray Matter Baseline
时间窗: baseline
Spinal cord gray matter cross-sectional area in mm2
Spinal Cord Gray Matter 24 month follow-up
时间窗: 24 month follow-up
Spinal cord gray matter cross-sectional area in mm2
Spinal Cord Gray Matter 6 month follow-up
时间窗: 6 month follow-up
Spinal cord gray matter cross-sectional area in mm2
Spinal Cord Gray Matter 12 month follow-up
时间窗: 12 month follow-up
Spinal cord gray matter cross-sectional area in mm2
次要结局
- MUNIX(baseline, months 6, 12, 18 and 24)
- Sniff nasal inspiratory pressure(baseline, months 6, 12, 18 and 24)
- Segmental Muscle Force(baseline, months 6, 12, 18 and 24)
- Spinal Cord Total Area(baseline, months 6, 12, 18 and 24)
- Spinal Cord White Matter(baseline, months 6, 12, 18 and 24)
- ALS Functional Rating Scale(baseline, months 6, 12, 18 and 24)
- Neurofilament Light Chain Levels(baseline, months 6, 12, 18 and 24)
研究者
Regina Schlaeger
PD Dr.
University Hospital, Basel, Switzerland