EASEE® System Pivotal Study for the United States of America

Обзор

The goal of this clinical trial is to demonstrate the safety and effectiveness of focal cortex stimulation with the EASEE(R) System in a large cohort of subjects with medically refractory focal epilepsy. The main questions it aims to answer are: 1. Is the percentage reduction of monthly seizure rate larger in the Intervention group than in the Control group at the end of the Blinded Phase? 2. Is the use of EASEE(R) System safe after up to 28 and up to 84 days? Participants will be asked to: * Complete a seizure diary for the duration of the clinical trial * Attend study visits for 20 months of their clinical trial participation * Undergo EASEE(R) System implant * Not be aware if neurostimulation is delivered during the Blinded Phase (6 months) * Receive neurostimulation for at least 12 months

Вмешательства

• Устройство Implantable minimaly invasive brain stimulator
  Participants are implanted with an electrode under the skin and above the skull. The electrode is connected to an implantable pulse generator in the chest area. The system is intended for focal cortex stimulation to treat medically refractory epilepsy. The stimulation is activated (turned ON) for 18 months.
• Устройство Implantable minimaly invasive brain stimulator
  Participants are implanted with an electrode under the skin and above the skull. The electrode is connected to an implantable pulse generator in the chest area. The system is intended for focal cortex stimulation to treat medically refractory epilepsy. The stimulation is not activated (turned OFF) for 6 months, than activated (turned ON) for 12 months.

Первичные конечные точки

• Percentage reduction in the monthly seizure rate [Effectiveness] [Срок оценки: Baseline and months 5 and 6]
• Incidence of Serious Adverse Events [Safety and Tolerability] [Срок оценки: From implant to days 28 and 84 post-implant]

Вторичные конечные точки (4)

• Seizure Frequency Responder Rate [Срок оценки: from Baseline to 6 months]
• Beck Depression Inventory (BDI-II) accross Arms [Patient Reported Outcome] [Срок оценки: Baseline to 6 months]
• Beck Depression Inventory (BDI-II) in the Intervention Group [Patient Reported Outcome] [Срок оценки: Baseline to 6 months]
• Quarterly Seizure Frequency Evaluation [Срок оценки: Baseline to 18 months]

Критерии участия

Критерии включения

• Adult between 18-75 years of age
• Diagnosis of drug-resistant focal epilepsy
• At least four (4) observable seizure manifestations per month
• Stable anti-seizure medication regimen

Критерии исключения

• Diagnostic of non-epileptic seizures
• Active idiopathic generalized epilepsy
• Recent status epileptics (<12 months)
• Clinically significant or unstable medical condition
• Active psychosis, major depression, suicidal ideation (<6 months)
• Pregnancy
• Implanted with brain stimulation device or active Vagus Nerve Stimulation

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07301346 · CV08-048

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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