Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Self-reported Seizure Frequency
研究概览
简要总结
The overall goal of this study is to open up the promising treatment of repetitive transcranial magnetic stimulation (rTMS), which has been shown to be effective against seizures in patients with surface neocortical foci, to a much larger population of patients with mesial temporal lobe epilepsy (MTLE) and other forms of epilepsy with deep foci, who are not currently considered good rTMS candidates.
The investigators hypothesize that rTMS can modulate the hyperexcitable state in patients with deep seizure foci by targeting its usage to accessible cortical partner regions. In this study the investigators aim 1) to map the functional connectivity of the epileptogenic mesial temporal lobe in patients with medically refractory mesial temporal lobe epilepsy; and 2) to perform a randomized controlled assessment of repetitive transcranial magnetic stimulation protocols applied to specific neocortical targets in mesial temporal lobe epilepsy. The methods used in this study will include magnetic resonance imaging (MRI) of the brain, electroencephalography (EEG), and transcranial magnetic stimulation (TMS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mesial temporal lobe epilepsy based on the combination of clinical semiology, neuroimaging findings, and electroencephalogram results.
- •At least 1 seizure with loss of awareness per 4-week period, on average, despite the use of antiepileptic drugs
排除标准
- •Prior brain surgery or exposure to transcranial magnetic stimulation
- •Rapidly progressive brain lesions
- •Inability to tolerate MRI or TMS
- •Specific MRI or TMS contraindication as set forth in standard protocols of our institution
结局指标
主要结局
Self-reported Seizure Frequency
时间窗: 12 weeks
The primary outcome measure will be the self-reported frequency of seizures with loss of awareness, as recorded by participants in written seizure diaries to be provided to investigators at the end of the 12-week assessment period beginning with the initial day of intervention. This seizure frequency will be expressed as the number of days on which seizures with loss of awareness occurred per 4-week interval during the assessment period.
次要结局
未报告次要终点
研究者
Bernard Chang
Associate Professor of Neurology
Beth Israel Deaconess Medical Center