Medtronic Registry for Epilepsy (MORE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 27
- 主要终点
- Seizure rate
研究概览
简要总结
The purpose of this observational registry is to evaluate the long-term effectiveness, safety and performance of market-released Medtronic Neuromodulation products for Deep Brain Stimulation (DBS) for the treatment of refractory epilepsy. In addition, healthcare resource use and patient reported outcomes, such as health related quality of life will be assessed.
详细描述
Introduction
The purpose of this observational registry is to evaluate the long-term effectiveness, safety and performance of market-released Medtronic Neuromodulation products for Deep Brain Stimulation (DBS) for the treatment of refractory epilepsy. In addition, healthcare resource use and patient reported outcomes, such as health related quality of life will be assessed.
Enrollment and Duration Patients meeting the eligibility criteria for the implantation of the Medtronic® DBS™ Therapy for Epilepsy will be included in the registry. Approximately 200 patients meeting all the eligibility criteria will be prospectively enrolled over an expected two-year period.
Approximately 30 centers, mainly from across Europe will participate. Center selection could also be extended to sites outside Europe.
Each patient will perform follow-up visits according to clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Fulfilling the criteria of labeling indications of Medtronic® DBS™ Therapy for Epilepsy.
- •Patient with diagnosis of refractory epilepsy as defined by 1981 ILAE (International League Against Epilepsy) classification, who have been implanted or will be implanted with Medtronic® DBS™ Therapy for Epilepsy.
- •For both cohorts, completed at least two full consecutive months diary information on seizure type and frequency prior to DBS implant (seizure type should be classified at least as simple partial, complex partial, partial evolving to secondarily generalized seizures, and generalized). In regard to the prospective cohort, the patient will be conditionally enrolled at the enrolment visit, and the criterion will be reassessed at the baseline visit.
- •Patient or patient's legally authorized representative able to understand and to provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC or local law and regulations.
排除标准
- •Incomplete and/or unreliable patient seizure diary based on the physician's judgment
- •Patient is currently enrolled in or plans to enroll in any concurrent drug, surgery and/or device study that may confound the results of this registry.
结局指标
主要结局
Seizure rate
时间窗: Participants will be followed for the duration of the registry, an expected average of 3 years
Evaluate the change in seizure rate from baseline over 2 years following DBS implant.
次要结局
- Seizure type and severity(Participants will be followed for the duration of the registry, an expected average of 3 years)
- Adverse Events characterization(Participants will be followed for the duration of the registry, an expected average of 3 years)
- Depression score assessment(Participants will be followed for the duration of the registry, an expected average of 3 years)
- Health Related Quality of Life (HRQoL)(Participants will be followed for the duration of the registry, an expected average of 3 years)