Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy (iVEAcare-FS)
2026年9月15日 更新者：iVEAcare
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.
研究概览
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：VP, Clinical Affairs
- 电话号码：+1 651 728 4832
- 邮箱：clinical@iveacare.com
学习地点
-
-
Queensland
-
South Brisbane、Queensland、澳大利亚、4101
- 招聘中
- The Mater
-
接触：
- Fraser Morris
- 电话号码：07 3163 2850
- 邮箱：Fraser.morris@mater.org.au
-
首席研究员：
- Donald Craig
-
-
Victoria
-
Clayton、Victoria、澳大利亚、3168
- 招聘中
- Monash Health
-
接触：
- May Ho
- 电话号码：03 9594 3051
- 邮箱：Wing.Ho@monashhealth.org
-
首席研究员：
- Udaya Seneviratne
-
Fitzroy、Victoria、澳大利亚、3065
- 招聘中
- St. Vincent's Hospital
-
接触：
- Emma Priest
- 电话号码：61 3 9231 3551
- 邮箱：Emma.Priest@svha.org.au
-
首席研究员：
- Amy Halliday
-
Heidelberg、Victoria、澳大利亚、3084
- 招聘中
- Austin Hospital
-
接触：
- Greesha Zacharia
- 电话号码：61 3 90357361
- 邮箱：Greesha.zacharia@umimelb.edu.au
-
首席研究员：
- Piero Perucca
-
Melbourne、Victoria、澳大利亚、3004
- 招聘中
- The Alfred Hospital
-
接触：
- Jack Germaine
- 电话号码：+61 3 9076 2029
- 邮箱：J.Germaine@alfred.org.au
-
接触：
- Camilla Goulsbra
- 电话号码：+61 3 9076 2719
- 邮箱：C.Goulsbra@alfred.org.au
-
首席研究员：
- Hugh Simpson
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：iVEAcare implant
Implanted with an iVEAcare Neuromodulation System
|
iVEAcare Neuromodulation System implant
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
iVEAcare Neuromodulation System Safety
大体时间：30 days
|
assessment of the rate of serious treatment-related (procedure, device- and/or therapy-related) adverse events
|
30 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Seizure Frequency
大体时间：3 months
|
Change from baseline in frequency of daily seizures, averaged over the 90 days prior to the visit
|
3 months
|
|
Seizure Severity
大体时间：3 months
|
Change from baseline in the Seizure Severity Questionnaire (SSQ) Score, which measures seizure intensity and duration on a scale of 1-7 where lower scores indicate lower seizure severity.
|
3 months
|
|
Change in Quality of Life
大体时间：3 months
|
Change from baseline in Quality of Life as measured by the Quality of Life in Epilepsy (QOLIE-31) Questionnaire on a scale from 0-100, where higher scores are considered better quality of life.
|
3 months
|
|
Participant View of Overall Status
大体时间：6 months
|
Subject Global Impression of Change (SGIC) compared to baseline.
SGIC is a single question where the participant indicates their status compared to baseline with 7 options ranging from Very Much Improved to Very Much Worse.
|
6 months
|
|
Clinician View of Overall Status
大体时间：6 months
|
Clinical Global Impression - Improvement (CGI-I) compared to baseline.
CGI-I is a single question where the physician indicates the participant's status compared to baseline with 5 options ranging from Much Better to Much Worse.
|
6 months
|
|
Depression
大体时间：6 months
|
Change from baseline in the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) on a scale from 6-24, where lower scores are considered less depression.
|
6 months
|
|
Anti-seizure Medication Use
大体时间：6 months
|
Change from baseline in anti-seizure medications
|
6 months
|
|
IPG Replacement Assessment
大体时间：At implant
|
The number of cases where the existing implanted lead works as intended with the IVEAcare IPG
|
At implant
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 学习椅：Terence O'Brien, MD、The Alfred Hospital and Monash University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月29日
初级完成 (估计的)
2027年7月1日
研究完成 (估计的)
2032年7月1日
研究注册日期
首次提交
2026年6月3日
首先提交符合 QC 标准的
2026年6月8日
首次发布 (实际的)
2026年6月10日
研究记录更新
最后更新发布 (实际的)
2026年9月18日
上次提交的符合 QC 标准的更新
2026年9月15日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.