NCT03446664已完成不适用
Microburst VNS Therapy Feasibility Study in Subjects With Refractory Epilepsy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LivaNova
- 入组人数
- 33
- 试验地点
- 17
- 主要终点
- Safety Primary Endpoint: Occurrence of stimulation related Adverse Events
研究概览
简要总结
Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of medically refractory epilepsy with primary generalized tonic-clonic seizures (limited to 20 subjects) or partial onset seizures including complex partial seizures with or without secondary generalization (limited to 20 subjects).
- •Must be on adjunctive antiepileptic medications.
- •Willing and capable to undergo multiple evaluations with functional magnetic resonance imaging (fMRI), electroencephalogram (EEG) and electrocardiogram (ECG).
- •4(A) For subjects with partial onset seizures: An average of ≥ 3 countable seizures per month based on seizure diary during the 3 month baseline period and no seizure-free interval greater than 30 days during those 3 months.
- •4(B) For subjects with PGTCs: Have at least ≥ 3 countable seizures during the 3 month baseline period. Note: Each seizure within a cluster may be counted as separate seizures.
- •12 years of age or older.
- •Subject is a male or non-pregnant female adequately protected from conception. Females of childbearing potential must use an acceptable method of birth control.
- •Provide written informed consent-assent/Health Insurance Portability and Accountability Act (HIPAA) authorization and self-reported measures with minimal assistance as determined by the investigator.
排除标准
- •Currently using, or are expected to use, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
- •A VNS Therapy System implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the subject.
- •A planned procedure that is contraindicated for VNS therapy.
- •History of implantation of the VNS Therapy System.
- •Currently receiving treatment from an active implantable medical device.
- •Presence of contraindications to MRI per the MRI subject screening record.
- •Known clinically meaningful cardiovascular arrhythmias currently being managed by devices or treatments that interfere with normal intrinsic heart rate responses (e.g., pacemaker dependency, implantable defibrillator, beta adrenergic blocker medications).
- •History of chronotropic incompetence (commonly seen in subjects with sustained bradycardia [heart rate < 50 bpm]).
- •Cognitive or psychiatric deficit that in the investigator's judgment would interfere with the subject's ability to accurately complete study assessments.
- •History of status epilepticus within 1 year of study enrollment.
- •Dependent on alcohol or narcotic drugs as defined by DSM IV-TR within the past 2 years, based on history. Tests for drug or alcohol use will not be administered.
- •Currently being treated with prescribed medication that contains cannabis or cannabis related substance including recreational use.
- •Any history of psychogenic non-epileptic seizures.
- •Currently participating in another clinical study without LivaNova written approval.
结局指标
主要结局
Safety Primary Endpoint: Occurrence of stimulation related Adverse Events
时间窗: Up to 12 months study visit
Assess stimulation/device related adverse events at follow-up visits month 6 and 12.
Efficacy Primary Endpoint: Percent change from baseline in seizure frequency
时间窗: Up to 12 months study visit
For the primary endpoint, the change in the seizure frequency per month compared to baseline will be evaluated for each subject at follow-up visits month 6 and 12.
次要结局
- Change from baseline in seizure frequency per month based on seizure diary provided by the sponsor(Up to 12 months study visit)
- All adverse events(Up to 12 months visit)
- Change from baseline in seizure severity(Up to 12 months study visit)
- Change from baseline in antiepileptic drug (AED) load(Up to 12 months study visit)
- Suicidality as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)(Up to 12 months study visit)
- Change from baseline in quality of life(Up to 12 months study visit)
研究者
研究点 (17)
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