跳至主要内容
临床试验/NCT06206629
NCT06206629已完成不适用

Evaluation of Contralateral R1 Component of the Blink Reflex in Patients With Amyotrophic Lateral Sclerosis

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Presence of a contralateral R1 component on blink reflex evaluation.

研究概览

简要总结

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting both upper and lower motor neurons. Electroneuromyography is an important tool for the diagnosis. Previous studies have shown that different components of the blink reflex, such as the latencies of homo- and contralateral R2 responses can be affected. Studies have found that a contralateral R1 component can appear in neurological diseases with affection of the central nervous system especially upper motor neuron, such as HTLV1 infection. Thus, you aim to determine if a contralateral R1 component could be present in ALS.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • For patients
  • Aged 18 to 99 years old
  • Referred for suspected motor neuromuscular disease
  • Collection of non-opposition
  • For healthy subjects:
  • Aged 18 to 99 years old
  • Absence of any neurological pathology
  • Collection of non-opposition

排除标准

  • Previous damage linked to another cause of the cranial nerves
  • Prior brainstem lesions
  • Persons deprived of liberty by a judicial or administrative decision
  • Patient under judicial protection, unable to express consent

结局指标

主要结局

Presence of a contralateral R1 component on blink reflex evaluation.

时间窗: Day 1

A blink reflex evaluation will be performed in all subjects : Blink reflex will be recorded with surface electrodes placed medially over the lower part of the eyelid, on the orbicularis oculi muscle, with a reference electrode 2 cm laterally. Stimuli will be delivered to the supraorbital nerve by surface electrodes with an intensity required to generate a consistent homolateral R1 response. A contralateral R1 component will be defined as an early compound muscle action potential recorded in the contralateral orbicularis oculi muscle.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Contralateral R1 in Amyotrophic Lateral Sclerosis | 临床试验