NCT03868189已完成不适用
Interest of Ultrasonography in Electroneuromyography: Single-blind Randomised Controlled Clinical Trial
Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2019年4月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 4
- 主要终点
- Supra-maximal stimulation intensity delivered by stimulation site on sensory nerves
研究概览
简要总结
Echo-nerve tracking during an electroneuromyographic (ENMG) examination by identifying the optimal stimulation site would reduce the stimulation intensities delivered to the patient and thus improve the tolerance of this examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requiring an electroneuromyogram whose indication allows the application of a standard protocol of examination.
- •Patient that has given his/her free and informed consent.
- •Patient that signed the consent form.
- •Patient with an health insurance plan.
- •The patient is at least 18 years old (≥).
- •he patient is under 80 years old (≤).
排除标准
- •Patient with symptoms of neuropathy during the screening.
- •Patient whose Neurological severity score (NSS) score is ≥
- •Patient whose neurological examination is abnormal and suggestive of neuropathy.
- •Patient presenting a pathology that could cause neuropathy (e.g. diabetes, renal failure, etc.).
- •Patient already participating in a category 1 research study (Jardé law).
- •Patient in an exclusion period determined by another study.
- •Patient under the protection of justice, under guardianship or under curatorship.
- •Patient refusing to sign the consent form.
- •Patient for which it is impossible to provide information about the study.
- •Pregnant patient, parturient, or breastfeeding.
结局指标
主要结局
Supra-maximal stimulation intensity delivered by stimulation site on sensory nerves
时间窗: Day 0
unit : milliampere (mA)
次要结局
- Average time per explored site (total duration divided by the number of explored nerves and muscles)(Day 0)
- Supra-maximal stimulation intensity delivered by stimulation site on the motor nerves(Day 0)
- Motor Amplitude per collection site(Day 0)
- Score of satisfaction(Day 0)
- Sensitivity Amplitude per collection site(Day 0)
- Number of explored unusual muscles(Day 0)
- Overall examination time between the beginning of the stimulation and the end of the myography examination(Day 0)
- Measurement of felt pain(Day 0)
- Total number of explored muscles(Day 0)
研究者
研究点 (4)
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