Innovative Repurposing of Trigeminal Nerve Stimulation of the Treatment of Epilepsy in Veterans
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Seizure frequency
研究概览
简要总结
Background: Epilepsy is a common neurological disorder among veterans. Medications do not control seizures in 1/3rd of patients, who often require neurostimulation. However, current neurostimulation devices are invasive. Objective: The investigators propose a novel clinical trial to repurpose the FDA-approved Cefaly device, designed for migraine relief, to treat epilepsy. The Cefaly device works by non-invasive Trigeminal neurostimulation (TNS). TNS has previously shown promising preliminary results in seizure improvement. Design: The investigators will engage 24 veterans with drug-resistant epilepsy, half of whom will receive standard care, while the other half will receive standard care plus Cefaly. This will be followed by a crossover of the treatment/control groups. The primary objective is to evaluate seizure frequency improvement over 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
There are no parties who are masked.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adults age 18 to 65 years of age at time of consent
- •Subject must have a confirmed diagnosis of epilepsy of at least 1 year, specified as focal onset epilepsy.
- •Focal epilepsy with motor signs
- •A minimum seizure frequency of one seizure over a 4-week period
- •Subject must have failed to achieve seizure control with at least two appropriate antiseizure medications (ASM) based on the 2009 ILAE definition of drug resistant epilepsy
- •Current treatment with at least 1 ASM with stable doses for at least three months
排除标准
- •Any condition that would impact a subject's ability to follow study procedures or subject's safety
- •History of significant adverse reactions to electrical stimulation (e.g. TEMS device)
- •Subjects with only focal aware nonmotor seizures
- •Women of childbearing age, pregnant or breastfeeding
- •Implanted cardiac pacemaker or implanted/wearable defibrillator or implanted metallic device in head
结局指标
主要结局
Seizure frequency
时间窗: 6 months
The primary outcome will be the reduction in seizure frequency with the treatment device compared to baseline measurements.
次要结局
- Beck Depression Inventory(6 months)
- QOLIE-31(6 months)
研究者
Hina Dave
Principal Investigator
Baylor College of Medicine