NEURO-LARYNX:Laryngeal Motor Evoked-potentials as a Biomarker of Vagus Nerve Stimulation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Laryngeal motor evoked potential (LMEP)
研究概览
简要总结
The goal of this study is to record and characterize larynx evoked motor potentials induced by vagus nerve stimulation. This study will include 10 adult patients implanted with a Vagus nerve stimulator, followed at the Center for Refractory Epilepsy at Cliniques St Luc. The inclusion criteria are: (1) patient aged between 18 and 65 years ; (2) cervical VNS device (Cyberonics, Houston, TX, USA) implanted for at least 6 months, (3) normal electrode impedance of the electrode. Exclusion criteria are (1) presence of a concomitant laryngeal pathology or recurrent laryngeal nerve damage, independent from VNS ; (2) important VNS side effects reported by the patient, such as severe dyspnea (grade III-IV) or severe pain in the neck/ear region.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged between 18 and 65 years
- •Vagus nerve stimulation implanted for at least 6 months
- •No impedance issues with the VNS electrode
排除标准
- •presence of a concomitant laryngeal pathology or RLN damage, independent from vagus nerve stimulation
- •important side effects of the VNS reported by the patient such as dyspnea, pain in neck/ear region and gastrointestinal complaints.
结局指标
主要结局
Laryngeal motor evoked potential (LMEP)
时间窗: the LMEP is recorded for 60 minutes from the moment the patient arrives to the clinic to perform the test
Characteristics of the laryngeal motor evoked potential Threshold : the mA of current output necessary for evoking the LMEP Latency : the time between the negative peak of the stimulation artifact and the first positive deflection of the LMEP Amplitude : the difference in μV between the lowest negative and the highest positive peak of the LMEP Duration : the time between the first positive deflection of LMEP and the return to the noise level Dose- response curve: the relation between increasing intensity of vagal nerve stimulation and amplitude of the LMEP
次要结局
未报告次要终点