Neural Circulatory and Respiratory Control in Patients With Epilepsy and the Risk of Sudden Unexpected Death.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Abnormal neural and respiratory control in the ictal and peri-ictal phase of patients with epilepsy and a high SUDEP-7 score when compared to patients with epilepsy and a low SUDEP-7 score.
研究概览
简要总结
The investigators believe epilepsy alters the way the body controls blood pressure, heart rate and breathing, and these changes increase the risk of sudden unexpected death in patients with epilepsy (SUDEP). SUDEP-7 is a risk scoring tool which may correlate with these changes to the heart and blood vessels. This research study measures those differences which may help identify new markers to help predict those patients at greatest risk in the future.
详细描述
The investigators overall goals are to determine whether measures of neural-circulatory control during the interictal waking and sleep states, as well as during the ictal/peri-ictal periods, are associated with SUDEP-7 score risk profiles in refractory epilepsy patients, and to translate these measures into tools for risk-stratification and preventative strategies for SUDEP.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-90
- •Able to consent
排除标准
- •History of non-epileptic spells/seizures,
- •Children/adolescents under age 18 years
- •Pregnancy
- •Non-compliance with Epilepsy Monitoring Unit safety procedures
- •Unable to consent
- •History of dysautonomia
- •Chronic Obstructive Pulmonary Disease (COPD)
- •Asthma (active requiring therapy)
- •Pulmonary hypertension
- •Known Structural Heart Disease
- •Heart failure
- •Myocardial infarction
- •Seizures due to traumatic injury
- •Prior surgery for epilepsy
- •Vasculitis
- •Raynaud's
- •Smoking (current or within the last 6 months)
研究组 & 干预措施
Low SUDEP-7 score
Patients with epilepsy who have a low SUDEP-7 score
High SUDEP-7 score
Patients with epilepsy who have a high SUDEP-7 score
结局指标
主要结局
Abnormal neural and respiratory control in the ictal and peri-ictal phase of patients with epilepsy and a high SUDEP-7 score when compared to patients with epilepsy and a low SUDEP-7 score.
时间窗: 3-7 days
Abnormal neural circulatory control in patients with epilepsy and high SUDEP-7 scores compared to patients with epilepsy and low SUDEP-7 scores.
时间窗: 24 hours
次要结局
未报告次要终点