ISRCTN40093015已完成未知
Analysing Neuroinflammation and Neurodegeneration in Amyotrophic Lateral Sclerosis: Quantitative Imaging in a Clinical Trial
CHU de Nimes0 个研究点目标入组 50 人开始时间: 2016年11月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 24/03/2017:
- •For participants with MND/ALS enrolled in MIROCALS:
- •1. Patients of either sex
- •2. 18 to 75 years of age (inclusive)
- •3. Probable or laboratory probable, or definite ALS by El Escorial revised ALS diagnostic criteria (Brooks et al. 2000)
- •4. Disease duration = 24 months
- •5. Vital capacity = 80% of predicted
- •6. No prior or present Riluzole treatment
- •7. Patient able to provide signed informed consent
- •8. Patient able to lie flat in comfort for up to 50 minutes
- •9. No contraindication to MRI such as cardiac pacemaker
- •10. Able to journey to the University of Sussex campus in Falmer for the MRI scan
- •Previous inclusion criteria:
- •For participants with MND/ALS enrolled in MIROCALS:
- •1. Patients of either sex
- •2. 18 to 75 years of age (inclusive)
- •3. Probable or laboratory probable, or definite ALS by El Escorial revised ALS diagnostic criteria (Brooks et al. 2000)
- •4. Disease duration = 24 months
- •5. Vital capacity = 80% of predicted
- •6. No prior or present Riluzole treatment
- •7. Patient able to provide signed informed consent
- •8. Patient able to lie flat in comfort for up to 50 minutes
- •9. No contraindication to MRI such as cardiac pacemaker
- •10. Able to journey to the University of Sussex campus in Falmer for the MRI scan
- •For healthy age-matched control subjects:
- •1. Patient able to provide signed informed consent
- •2. Patient able to lie flat in comfort for up to 50 minutes
- •3. No contraindication to MRI such as cardiac pacemaker
- •4. Able to journey to the University of Sussex campus in Falmer for the MRI scan
- •5. No diagnosis of neurodegenerative or neurological disease
排除标准
- •1. Other causes of neuromuscular weakness
- •2. Presence of other neurodegenerative diseases
- •3. Significant cognitive impairment, clinical dementia or psychiatric illness
- •4. Severe cardiac or pulmonary disease
- •5. Other diseases precluding functional assessments
- •6. Contraindication for lumbar puncture
- •7. Other life-threatening diseases
- •8. Documented auto-immune disorders except asymptomatic Hashimoto thyroiditis
- •9. Women of child-bearing age without contraception or pregnant or breastfeeding
- •10. Any clinically significant laboratory abnormality
- •11. Other concurrent investigational medications
- •12. Unable to take Riluzole
- •13. Patient unable to lie flat in comfort for up to 50 minutes for scan
- •14. Contraindication to MRI such as cardiac pacemaker
- •15. Patient unable to provide informed consent
研究者
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