Multimodal Image-guided Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Refractory Partial Epilepsy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- 50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment
研究概览
简要总结
The investigators will treat patients with fully characterized refractory unifocal neocortical epilepsy with a technique that delivers magnetic waves (transcranial magnetic stimulation, TMS) to the region that causes the epilepsy. Active rTMS applied over the epileptogenic focus will reduce seizure frequency compared with sham rTMS.
详细描述
- Background and study aims
Epilepsy is a disease that causes repetitive seizures. In 60% of people with epilepsy, these seizures start in a small zone of the brain (focal or partial epilepsy). This zone can be in the depth of the temporal lobe (mesial temporal lobe epilepsy) or in another brain region (neocortical epilepsy). Even with optimal medical care, up to 30% of people with epilepsy continue to have seizures.
The investigators will treat people with neocortical partial epilepsy with a technique that delivers magnetic waves (transcranial magnetic stimulation, TMS) to the region that causes the epilepsy. The investigators have good reasons to believe that there will be fewer seizures during several weeks after treatment. 2. Who can participate?
You have neocortical focal epilepsy. A doctor who specializes in epilepsy made this diagnosis. You had at least one seizure recorded while in an epilepsy monitoring unit. You had an MRI scan of the brain. You can deliver us all the results of the tests you had.
You continue to have more than 4 seizures a month. You tried a least two different schemes of anti-epileptic drugs as prescribed by your doctor and those schemes were well tolerated. Nevertheless this never cured the seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fully characterized refractory unifocal neocortical epilepsy (i.e. the epileptogenic zone is well defined)
- •on a stable drug regimen for at least one month,
- •able to complete a seizure dairy either by the patient or by a significant other
排除标准
- •Metal in the head including deep brain stimulators, aneurysmal clips, ventricular shunts, cochlear implants, ossicular reconstruction of the middle ear...
- •pacemaker, implantable cardioverter-defibrillator (ICD)
- •psychogenic non-epileptic seizures and other non-epileptic spells
研究组 & 干预措施
figure-of-eight active rTMS coil
rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
干预措施: figure-of-eight active rTMS coil (Device)
round active rTMS coil
rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
干预措施: round active rTMS coil (Device)
sham rTMS coil (figure-of-eight)
rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
干预措施: sham rTMS coil (figure-of-eight) (Device)
结局指标
主要结局
50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment
时间窗: week 12 after each intervention
Number of participants achieving a 50% or greater reduction in seizure frequency from baseline
次要结局
- Seizure Frequency After Active rTMS Treatment Compared With Placebo Treatment(week 12 after each treatment)