Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS)

MedtronicNeuro31 个研究点分布在 4 个国家目标入组 29 人2020年3月5日

适应症Epilepsy

干预措施Activa™ PC and Percept™ PC Neurostimulation Systems

概览

阶段: 不适用
干预措施: Activa™ PC and Percept™ PC Neurostimulation Systems
疾病 / 适应症: Epilepsy
发起方: MedtronicNeuro
入组人数: 29
试验地点: 31
主要终点: Percentage Reduction in Total Seizure Frequency
状态: 终止
最后更新: 8天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted participants through 3 years of follow-up.

注册库

clinicaltrials.gov

开始日期

2020年3月5日

结束日期

2026年2月26日

最后更新

8天前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

MedtronicNeuro

责任方

Sponsor

入排标准

入选标准

•Focal (partial) onset seizures (based on International League Against Epilepsy (ILAE) 2017 classification) that may or may not evolve to a bilateral tonic-clonic seizure (secondary generalization). The final determination shall be made by the Investigator based on a clinical description of the seizures and previous diagnostic testing that includes, at a minimum, video EEG (inpatient or ambulatory) that captured at least one ictal event
•Anticipated average of 6 or more focal (partial) onset seizures per month during CMM phase, with no more than 30 consecutive seizure-free days during the CMM phase
•Refractory to at least 3 antiepileptic drugs (AEDs) due to lack of effectiveness
•Age 18 or older at the time of enrollment
•Willing and able to complete the diary, with or without the assistance of a caregiver, in a reliable way as assessed by the clinical staff
•Able to use the Patient Programmer with or without the assistance of a caregiver
•Ability of the subject or legal representative to understand and provide signed consent for participating in the study
•Willing and available to attend visits as scheduled and to comply with the study protocol

排除标准

•Generalized onset epilepsy type (based on International League Against Epilepsy (ILAE) 2017 classification)
•Seizure frequency is too frequent that subject is unable to provide daily count in order to maintain a reliable seizure diary
•Any episode of convulsive status epilepticus within the 12 months prior to the Enrollment Visit
•Previous diagnosis of psychogenic/non-epileptic seizures within the 12 months prior to the Enrollment Visit
•Surgical candidate for and willing to undergo resective surgery
•Evidence of a neurological condition that is likely to progress (e.g., brain tumor, arteriovenous malformations or cavernous angiomas)
•Diagnosed with a progressive or degenerative neurological disorder affecting the brain
•Significant medical condition that may impact study participation in the opinion of the investigator
•Presence of any of the following within 1 year prior to the Enrollment Visit: psychiatric illness hospitalization, suicide attempt or symptoms of psychosis (hallucinations, delusions) unrelated to an ictal state, a post-ictal state or a medication
•Malignancy or history of malignancy within 1 year prior to the Enrollment Visit (excluding resected basal cell carcinomas)

研究组 & 干预措施

Active Deep Brain Stimulation (DBS)

干预措施: Activa™ PC and Percept™ PC Neurostimulation Systems

结局指标

主要结局

Percentage Reduction in Total Seizure Frequency

时间窗: Pre-implant compared to 36 months post-implant

The percentage of total seizure frequency reduction will be assessed using the participant seizure diaries to demonstrate DBS therapy effectiveness

次要结局

Percentage Reduction in Total Disabling Seizure Frequency(Pre-implant compared to 12 months post-implant)
Percentage Reduction in Total Seizure Frequency(Pre-implant compared to 12 months post-implant)
Percentage Reduction in Temporal Lobe Originated Seizure Frequency(Pre-implant compared to 12 months post-implant)
SUDEP Rate Characterization(Implant to 36 months post-implant)