Effects of Green Light Exposure on Epileptic Spikes in Patients With Refractory Epilepsy
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Effects of exposure to a narrow band of green light (520-540 nm) at low intensities (1-10 cd/m2) on the pattern of electrical activity in the cortex of epilepsy patients.
研究概览
简要总结
The purpose of this study is to obtain preliminary data in advance of a larger clinical trial aimed to test whether a single session of green light exposure can lead to a clinically significant reduction in epileptic spikes in patients with medically-refractory epilepsy. As this is a potentially fragile patient population, the study will test safety and tolerability as well as efficacy.
详细描述
The trial is designed to detect (1) change in spike frequency on EEG before and after exposure to low intensity green light, and (2) presence or absence of neurologic/systemic symptoms referable to exposure of the pre-selected duration, intensity, and band of green light.
Our primary aim is to determine whether prolonged exposure (120 minutes) to a narrow band of green light (520-540 nm) at low intensities (1-10 cd/m2) alters the pattern of electrical activity in the cortex of epilepsy patients.
The primary outcome measure for this aim will be the fraction of patients in which the number of epileptiform discharges (spikes or sharp waves) decrease, per recording, in response to green light exposure, as determined by spike frequency detected via scalp EEG before and after green light exposure.
The investigators anticipate that the primary outcome measures of safety and tolerability will not differ from the previously established measures of green light exposure for migraine (Noseda et al. 2016). The investigators will use only low intensities (1-10 cd/m2) of green light which is well tolerated in adults and children (Main et al. 2000). In addition, given limited experience with conventional green light exposure in epilepsy, the investigators predict that post-exposure to green light, patients will have an improvement on the post-exposure EEG (decreased spike frequency).
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
- 6 Months 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 months-30 years of age
- •Epileptic spike frequency ≥1 epileptic spike per minute at baseline, as determined by scalp EEG recording
- •Admitted to the Boston Children's Hospital Epilepsy Long Term Monitoring Unit at the time of enrollment
排除标准
- •Cataracts
- •Retinol disease
- •Any history of or currently not well controlled ophthalmic disease that prevents transmission from the retina to the optic nerve
- •Clinical seizure 4 hours or less before anticipated green light exposure
结局指标
主要结局
Effects of exposure to a narrow band of green light (520-540 nm) at low intensities (1-10 cd/m2) on the pattern of electrical activity in the cortex of epilepsy patients.
时间窗: 120 minutes
The primary outcome measure for this aim will be the fraction of patients in which the number of epileptiform discharges (spikes or sharp waves) decrease, per recording, in response to green light exposure, as determined by spike frequency detected via scalp EEG before and after green light exposure.
次要结局
- To consider probable confounders, such as etiology and comorbidities, this information will be acquired through routine clinical care documentation by the study MD for (2):(10 minutes)
- To consider probable confounders, such as etiology and comorbidities, this information will be acquired through routine clinical care documentation by the study MD for (3):(10 minutes)
- To consider probable confounders, such as etiology and comorbidities, this information will be acquired with standardized NIH epilepsy data acquisition forms for (1):(10 minutes)
研究者
Alexander Rotenberg
Principal Investigator
Boston Children's Hospital