Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy

Обзор

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.

Вмешательства

• Устройство iVEAcare Neuromodulation System
  iVEAcare Neuromodulation System implant

Первичные конечные точки

• iVEAcare Neuromodulation System Safety [Срок оценки: 30 days]

Вторичные конечные точки (8)

• Seizure Frequency [Срок оценки: 3 months]
• Seizure Severity [Срок оценки: 3 months]
• Change in Quality of Life [Срок оценки: 3 months]
• Participant View of Overall Status [Срок оценки: 6 months]
• Clinician View of Overall Status [Срок оценки: 6 months]
• Depression [Срок оценки: 6 months]
• Anti-seizure Medication Use [Срок оценки: 6 months]
• IPG Replacement Assessment [Срок оценки: At implant]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 3 центра

• The Mater — South Brisbane
• St. Vincent's Hospital — Fitzroy
• The Alfred Hospital — Melbourne

Идентификаторы

NCT: NCT07640191 · CLN-000001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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