NCT05562960已完成不适用
Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP
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
- 5
- 试验地点
- 1
- 主要终点
- Change in ALSFRS-R decline
研究概览
简要总结
Patient with amyotrophic lateral sclerosis (ALS) having anti-NRIP autoantibody showed titer-dependent detrimental Effects. Plasmapheresis might benefit this subgroup of patients via removal of anti-NRIP autoantibody
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with amyotrophic lateral sclerosis (ALS) at the age more than 20 years and having plasma anti-NRIP autoantibody.
- •Agree to receive plasmapheresis intervention.
- •Agree to participate in the trial and receive serial examinations and follow up.
排除标准
- •Patients without plasma anti-NRIP autoantibody.
- •Patients requiring permanent ventilator support for ALS progression.
- •Not able to receive plasmapheresis or trial-related examinations.
- •Under pregnancy.
- •Blood fibrinogen level less than 50 mg/dl.
- •Specific ALS subtypes, including primary lateral sclerosis, progressive muscular atrophy, flail arm syndrome, or flail leg syndrome.
研究组 & 干预措施
ALS patients receiving plasmapheresis
Other
Plasmapheresis in ALS patients with different titers of autoantibody against NRIP
干预措施: Plasmapheresis (Procedure)
结局指标
主要结局
Change in ALSFRS-R decline
时间窗: Before (3-month) and after (3-month) intervention
Change in ALSFRS-R decline before (3-month) and after (3-month) intervention. \<ALSFRS-R indicates revised ALS functional rating scale, ranged from 0 to 48 with the higher, the better motor function\>
次要结局
- Change in ALSFRS-R decline(Before (3-month) and after (6-month) intervention)
- Changes in ALSFRS-R score(Day 0 to days 30, 90, and 180)
- Change in compound motor action potentials(Before intervention and on day 90)
- Change in force vital capacity(Before intervention and on day 90)
- Changes in anti-NRIP titer(Day 0 to days 30, 90, and 180)
- Any adverse effect under plasmapheresis(Within 6 months during and after plasmapheresis)
研究者
研究点 (1)
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