Seizure Detection With a Deep Brain Stimulation System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Thalamic seizure detection in the epilepsy monitoring unit
研究概览
简要总结
The purpose of this study is to determine the feasibility of chronic ambulatory thalamus seizure detection. The sensitivity, specificity, and false alarm rate of thalamus seizure detection will be calculated using recordings from a deep brain stimulation system, assessed relative to concurrent gold-standard video-EEG monitoring collected in the in-patient setting (epilepsy monitoring unit), in 5 patients with drug resistant epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the inclusion criteria to participate in this study:
- •18 years of age and older.
- •Implanted with a clinical DBS system for epilepsy with brain recording capabilities (Medtronic Percept™ DBS).
- •Subject or legally authorized representative is able to understand study procedures and to comply with them for the entire length of the study.
排除标准
- •All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation:
- •Health status or any clinical conditions (e.g., life expectancy, co-existing disease) that, in the opinion of the site investigator, would pose undue risk to undergo epilepsy monitoring unit evaluation for the purpose of seizure characterization.
- •Women will verify not pregnant, and if applicable, have urine pregnancy test.
- •Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- •Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
研究组 & 干预措施
Thalamus seizure detection with a DBS system
Thalamus seizure detection by a DBS system, validated with concurrent in-hospital gold standard video EEG monitoring.
干预措施: Phase 1-Validation of thalamus seizure detection with concurrent video EEG monitoring (Device)
Thalamus seizure detection with a DBS system
Thalamus seizure detection by a DBS system, validated with concurrent in-hospital gold standard video EEG monitoring.
干预措施: Phase 2-DBS Stimulation with Medtronic Percept DBS device-Out Patient (Device)
结局指标
主要结局
Thalamic seizure detection in the epilepsy monitoring unit
时间窗: 2 years
The sensitivity, specificity, and false alarm rate of thalamus seizure detection will be calculated using recordings from a deep brain stimulation system, assessed relative to concurrent gold-standard video-EEG monitoring collected in the epilepsy monitoring unit, in patients with drug resistant epilepsy.
次要结局
- Ambulatory thalamus seizure detection with constrained DBS recordings(2 years)
研究者
Nicholas Gregg
Principal Investigator
Mayo Clinic