Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Effect of blue light on VNS biomarkers
研究概览
简要总结
Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. This project aims at understanding how exposure to blue enriched light may influence VNS effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of VNS action. This could possibly lead to new therapeutic strategies to increase efficacy of VNS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •VNS implanted since at least 3 months age >18-60 years; IQ >55 on Wechsler scale (normal status or mild cognitive impairment)
- •healthy participants aged between 18 and 35 years without any medical history (neurological / psychiatric disease)
排除标准
- •other medical implanted devices than VNS, ocular diseases
- •Helthy participants:
- •medical implanted devices, cerebral trauma, ocular disease
研究组 & 干预措施
Patients with refractory epilepsy
Patients will not receive any drugs, but will participate to experiments involving electroencephalograpy, pupillometry and light administration.
干预措施: electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration (Other)
Healthy subjects
Subjects will not receive any drugs, but will participate to experiments involving electroencephalograpy, pupillometry and light administration.
干预措施: transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration (Other)
结局指标
主要结局
Effect of blue light on VNS biomarkers
时间窗: 4 years
Blue light increases VNS induced electroencephalogram desynchronisation in implanted patients
次要结局
未报告次要终点