Determination of Threshold of Stimulation, Tolerability and Safety of Magnetic Nerve Stimulation In Healthy Subjects: an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change in perfusion index of cerebral blood flow
研究概览
简要总结
Find the stimulation threshold of the facial nerve (ganglion Geniculate) associated with tolerability and safety in subjects Healthy humans.
详细描述
Magnetic stimulation of the facial nerve (geniculate ganglion) in humans can induce changes in cerebral blood flow safely, without generating adverse effects unknown to the technique.
Our specific objectives:
- Perform tolerability and safety tests of magnetic stimulation on the facial nerve.
- Establish the optimal stimulation threshold associated with tolerability in order to apply it to the final design of the Magnetic Stimulation (MS) system.
- Measure whether the threshold found shows any increase in cerebral perfusion in the subject with respect to their baseline.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •Normal audiometry chart (Evaluated at the time of your inclusion).
- •Normal neurological examination at time of inclusion.
排除标准
- •Subjects with a diagnosis of epilepsy, seizures, facial nerve palsy, migraine or recurrent headaches, glaucoma or neuropathies.
- •Subjects in breastfeeding or in pregnancy. (To be confirmed with test strip).
- •Subjects with acute or acute chronic medical conditions.
- •Age less than 20 years or greater than 40 years.
- •Carotid surgery.
- •Episodes of syncope.
- •Known arteriosclerosis anywhere on the body
- •Metal implants (cochlear implants, pacemakers, metal prostheses).
- •Intracranial abnormalities observed by MRI or MRA (Evaluated at time of inclusion of the subject).
- •Intraocular pressure> 22mmHg (Evaluated at time of inclusion of the subject)
研究组 & 干预措施
Vitalflow treatment
The subject's exposure will be through a ramp model of increments in magnetic stimulation power delivered to the facial nerves bilaterally. Increases in magnetic stimulation will be 10% for 10 seconds from 10% to 60%. Subsequent to this will be evaluated for 5 minutes in the power of tolerability of the subject (60% 70%, 80% or 90%).
干预措施: magnetic facial nerve stimulation (Device)
结局指标
主要结局
Change in perfusion index of cerebral blood flow
时间窗: 10 minutes post-stimulation
An algorithm to calculate the perfusion index using magnetic resonance images across the entire brain
次要结局
未报告次要终点