A Prospective Long-Term Follow-Up Study to Evaluate the Use of the Minder Device to Aid in Treatment After Actionable Event Identification in Patients Diagnosed With Epilepsy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 17
- 主要终点
- To evaluate the Minder System to aid in treatment following an actionable event by comparing change using the Patient Global Impression scale (PGIC) from baseline to follow-up.
研究概览
简要总结
The purpose of this research is to address the challenges of correctly monitoring, managing, and diagnosing epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research is being done to understand how the Minder System helps physicians make decisions about participant's epilepsy treatment after an actionable event. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational.
Participants that have completed the DETECT study and received the Minder System previously will consent to join this long-term follow-up observational study. The study will collect information about general wellbeing, use of healthcare services, and experience using the Minder data over time to support long-term epilepsy care.
All participants will continue to be followed by their treating physician and undergo assessments and visits every six (6) months until two (2) years after receiving the Minder device.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant met all inclusion criteria, was enrolled in the DETECT study, and received the Minder device
- •Participant completed the DETECT study by receiving an actionable event or by completing the 6-month follow-up visit
- •Participant continues to have the Minder device implanted
- •Participant must continue to meet relevant DETECT study inclusion criteria
排除标准
- •Participant meets any relevant DETECT study exclusion criteria including needing treatments or assessments that are not indicated with the Minder System like Magnetic Resonance Imaging (MRI)
研究组 & 干预措施
Observational
Minder System
干预措施: Previous receipt of the Minder System (implantable continuous electroencephalographic (EEG) monitoring (iCEM) system) (Device)
结局指标
主要结局
To evaluate the Minder System to aid in treatment following an actionable event by comparing change using the Patient Global Impression scale (PGIC) from baseline to follow-up.
时间窗: 2 years
次要结局
未报告次要终点
