Cerebral Oxygen Saturation and Cytochrome Oxidase REDOX State in Children With Epilepsy: A Pilot Study - Multichannel Near-infrared Spectroscopy (NIRS) for Epilepsy Seizure Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in CCO redox state and oxygen saturation
研究概览
简要总结
The purpose of this pilot study is to describe the relationship of regional cerebral oximetry and cytoximetry, measured using near-infrared spectroscopy, with seizure activity in the periictal period in children with epilepsy.
详细描述
Pediatric subjects with partial (focal) epilepsy seizure disorders will be studied using near-infrared spectroscopy for cytochrome c oxidase (CCO) redox state and blood oxygen saturation. Along with routine EEG monitoring, a set of light sensors, called optodes, attached to a net/cap/device that goes over the head will be put on. These optodes will send out very weak red light signals, which will pass through the scalp and bounce back to detectors on the netting. The changes in the light signals will be used to calculate the changes in the various forms of the enzyme CCO, as well as the amount of oxygen in the blood. We hope to use these measurements to study changes in blood flow and cellular energy usage in the brain during seizures, which might help us to understand epilepsy better in the future and design better treatments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric epilepsy patients who can provide assent (lower limit age 7).
- •Diagnosis of partial (focal) epilepsy and/or frequent interictal spike activity on EEG.
- •Clinical EEG supporting diagnosis of partial(focal) epilepsy and/or frequent interictal spike activity
排除标准
- •History of unrepaired or palliated congenital cyanotic heart disease
- •History of traumatic head injury or head wounds to the extent that precludes safe and consistent placement of NIRS-EEG probes.
- •Guardian does not give consent or patient is unable to consent/assent to participate in the study
- •Clinical care provider or investigator determines the patient is not appropriate candidate for the study
- •Lack of current seizure care plan in Children's Hospital medical record
- •Known sensitivity or allergy to EEG gel
结局指标
主要结局
Change in CCO redox state and oxygen saturation
时间窗: 1 week
Regional cerebral saturation of oxygen and/or cytochrome oxidase redox state will change prior, during, and after onset of seizure activity when compared to non-seizure side of brain.
次要结局
未报告次要终点
研究者
Rene Andrade-Machado
Assistant Professor
Medical College of Wisconsin