NCT01978470Unknown不适用
External Trigeminal Nerve Stimulation for Epilepsy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety of eTNS
研究概览
简要总结
The purpose of this study is to evaluate the tolerability and safety of the NeuroSigma eTNS system.
详细描述
This study evaluates the safety and tolerability of the NeuroSigma eTNS system for the treatment of drug resistent partial seizures.
Up to 20 subjects, ages 18 - 75, with partial epilepsy will be enrolled in an acute 4-week tolerability study at Olive View/UCLA Medical Center .......
Enrolled subjects will be asked to maintain an accurate seizure calendar, and will be seen at the initial visit, then at two and four weeks.......
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Partial onset seizures (complex partial or secondary generalized tonic-clonic)
- •At least one seizure every three months
- •No serious or progressive medical or psychiatric illness
- •At least one complex partial or generalized tonic-clonic seizure in the last three months
- •MRI or EEG consistent with localization-related or partial epilepsy
- •Exposure to at least two anti-epileptic drugs at adequate doses
- •Concurrent use of at least one anti-epileptic drug at adequate doses
- •No change in anti-epileptic drug dose for at least 30 days prior to study enrollment
排除标准
- •Vagus nerve stimulation (VNS)
- •History of non-epileptic seizures
- •Inability to maintain accurate seizure calendars (self or caregiver)
- •Frequent use of benzodiazepines for seizure clusters defined as greater that four times per month
- •History of facial pain or trigeminal neuralgia
- •Pregnancy
结局指标
主要结局
Safety of eTNS
时间窗: Four weeks
Number and percent of subjects with adverse events related to the device at four weeks.
次要结局
- Beck Depression Inventory(Four weeks)
- Quality of Life(Four weeks)
- Systolic Blood Pressure and Heart Rate(Four weeks)
- Skin Irritation(Four weeks)
研究者
研究点 (1)
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