NCT01436695Unknown不适用
Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers
Epicall LTD1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Lack of adverse events
研究概览
简要总结
Epilepsy is a syndrome of episodic brain dysfunction characterized by recurrent seemingly unpredictable spontaneous seizures. The occurrence of the seizure in patients without any forewarning is the most debilitating aspect of the disease.
The Epicall system is intended for early detection of seizure related life threatening events by monitoring per-seizures biomarkers. The system is based on a sticker placed on the side of the face. The external sticker incorporates EOG (electrooculograph electrode) and PPG (photoplethysmograph electrode) sensors for continuous monitoring of:
- Heart Rate (base line, increase, decrease, asystole).
- Extra ocular eye movement (blinking, eye deviation, roving eye movements).
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children age 1 year -18 years old.
- •Hospitalized patient who is diagnosed with epilepsy.
- •Patient's parents/care giver able to comprehend and give informed consent for participation in this study.
- •Patient's parents/care giver must commit to both screening and monitoring visits.
- •Patient's parents/care giver must sign the Informed Consent Form.
排除标准
- •Patient with any infection / abscess / bleeding / blister / crack / edema / fissure / ulcer / pain in monitoring electrode area
- •General weakness.
- •Patient's parents/care giver objects to the study protocol.
- •Concurrent participation in any other clinical study.
- •Physician objection.
结局指标
主要结局
Lack of adverse events
时间窗: 1-2 weeks
次要结局
- Epicall feasibility for monitoring pre-seizure biomarkers(1-2 weeks)
研究者
研究点 (1)
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