Safety and Feasibility of St. Mark's Electrode for the Hypoglossal Nerve and Cortico-lingual Pathway Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Severe adverse reactions and events rate
研究概览
简要总结
The possibility of registering the M-response and the motor evoked potential (MEP) from the muscles of the tongue by using the St. Mark's electrode will be evaluated. The safety of method will be confirmed. Registered parameters will be compared with other known methods and comparative effectiveness of proposed method will be determined.
The study will involve healthy volunteers without clinical symptoms of hypoglossal nerve and cortico-lingual pathway lesions and without surgical interventions in the tongue .The volunteers will be examined once for the parameters of the amplitude and latency of the M-response and MEP, as well as the difference between these indicators at different sides of the examination during nerve conduction study (NCS) and transcranial magnetic stimulation (TMS) of the hypoglossal nerve and the cortico-lingual pathway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Absence of clinical symptoms of impaired hypoglossal nerve and cortico-lingual pathways;
- •Absence of history of surgical interventions in the tongue area;
- •The subject has read the information sheet and signed the informed consent.
排除标准
- •Clinical symptoms of hypoglossal nerve or cortico-lingual pathway (dysarthria, dysphagia (pseudobulbar palsy) lesions, flaccid paralysis of the tongue muscles, atrophy and fasciculations of the tongue muscles);
- •Tumors, metastatic lesions and cysts in the region of the brain stem, posterior cranial fossa, base of the skull, in the region of the carotid segment, salivary glands;
- •Vascular pathologies in the carotid sinus area: vascular malformations, dissection of the internal carotid artery aneurysm, venous thrombosis;
- •Recent dental procedures with one of the following complications: development of an abscess, direct injury to the nerve by medical equipment, development of hematoma;
- •History of carotid endarterectomy;
- •Motor neuron disease and other neurodegenerative or demyelinating diseases;
- •History of cancer and courses of radiation therapy;
- •The presence of implantable programmable devices.
研究组 & 干预措施
Hypoglossal nerve conduction study.
干预措施: Hypoglossal nerve conduction study (Diagnostic Test)
Hypoglossal nerve conduction study.
干预措施: Transcranial magnetic stimulation of hypoglossal nerve (Diagnostic Test)
结局指标
主要结局
Severe adverse reactions and events rate
时间窗: During the intervention and 1 day after the intervention
Severe adverse reactions and events will be monitored and registered during procedure of nerve stimulation and on the day of study
次要结局
- Rate of MEP registration during TMS of cortical-lingual pathway using the St. Mark's electrode in healthy volunteers.(During the intervention)
- Rate of M-wave registration during NCS of hypoglossus nerve using the St. Mark's electrode in healthy volunteers.(During the intervention)