Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- iVEAcare Neuromodulation System Safety
研究概览
简要总结
The purpose of this study is to assess the safety and performance of the iVEAcare Neuromodulation System for the treatment of drug-resistant epilepsy.
The main questions it aims to answer are:
What medical problems do participants have when being implanted with and using the iVEAcare system? Does the iVEAcare neurostimulator reduce seizure frequency and severity in patients with drug-resistant epilepsy? Does the iVEAcare neurostimulator improve quality of life in patients with drug-resistant epilepsy?
All participants will be implanted with an iVEAcare neurostimulator, and researchers will look at whether any medical problems are caused by the implant procedure or device, and how stimulation changes seizure frequency and severity and participant quality of life compared to when the participant enrolled.
Participants will:
Be implanted with an iVEAcare device. Visit the clinic 1-month, 3-months, 6-months, 1-year, 18-months and then annually through 5 years where they will be asked to answer questionnaires about their seizures and quality of life.
Keep a diary of the number of seizures they have each day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4 to 75 years.
- •Focal (partial) onset seizures (with or without secondary generalization) or generalized seizures that are refractory to anti-seizure medications.
- •A minimum of 4 seizures per month averaged over the 90 days prior to enrollment.
- •Participant is diagnosed with Drug Resistant Epilepsy (DRE) - Failure to achieve seizure control with adequate trials of two or more tolerated anti-seizure medications.
- •Anti-seizure medications must be at a steady state for a minimum of 30 days and remain stable through the 6-month post-activation study visit. Rescue medications may still be used as necessary
排除标准
- •Unsuitable for iVEAcare Neuromodulation System implant surgery.
- •Deteriorating neurologic or other deteriorating medical conditions.
- •Previous left vagotomy (left vagus nerve cut to treat another disorder).
- •A condition currently requiring diathermy treatment anywhere in their body (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy).
- •Known vagal neuropathy, or other reasons that the left vagus nerve is not appropriate for implant.
- •Vocal cord paralysis.
- •Prior therapeutic brain surgery for epilepsy within 6 months prior to the baseline visit.
- •Currently implanted with an Implantable Cardiac Defibrillator (ICD), pacemaker, Deep Brain Stimulator (DBS), Responsive Neurostimulator (RNS), Spinal Cord Stimulator (SCS), Peripheral Nerve Stimulator (PNS), Sacral Nerve Stimulator (SNS), carotid baroreceptor stimulator, cochlear implant, or currently using external stimulation devices such as a Transcutaneous Electrical Nerve Stimulator (TENS). Note: Participants who currently have a commercially available VNS system for drug-resistant epilepsy and are eligible for a generator replacement (due to nearing end of life) can receive the iVEAcare Implantable Pulse Generator (IPG) alone if their existing lead has been confirmed to be functioning properly preoperatively and intraoperatively.
- •Pregnant or planning to be pregnant in the next 12 months. .
- •Any active malignant disease (not including skin cancer).
- •Any active infection in the vicinity of the implant site or any systemic infection.
- •Poorly controlled diabetes (Type I or Type II) determined by HbA1c >8% (or > 64 mmol/mol
研究组 & 干预措施
iVEAcare implant
Implanted with an iVEAcare Neuromodulation System
干预措施: iVEAcare Neuromodulation System (Device)
结局指标
主要结局
iVEAcare Neuromodulation System Safety
时间窗: 30 days
assessment of the rate of serious treatment-related (procedure, device- and/or therapy-related) adverse events
次要结局
- Seizure Frequency(3 months)
- Seizure Severity(3 months)
- Change in Quality of Life(3 months)
- Participant View of Overall Status(6 months)
- Clinician View of Overall Status(6 months)
- Depression(6 months)
- Anti-seizure Medication Use(6 months)
- IPG Replacement Assessment(At implant)