Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Epilepsy - Case Study in Patients With Epilepsia Partialis Continua (EPC) and Refractory Status Epilepticus (SE)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Seizure diary
研究概览
简要总结
The purpose of this study is to assess the effects of repetitive transcranial magnetic stimulation (rTMS) as a treatment for Epilepsia Partialis Continua (EPC) or refractory Status Epilepticus (SE), when standard clinical treatments have failed.
详细描述
- Study design:
This is a case study, including up to 10 patients with EPC or refractory SE that are admitted to the service in the coming 5 years.
If circumstances permit so, a baseline evaluation of seizure frequency over 1 week and a 24-hour baseline EEG registration will be obtained, as well as a baseline clinical neurologic exam. In case of therapeutic urgency, these baseline measurements will be omitted.
The treatment itself consists of multiple stimulation sessions over multiple days, decided upon based on patient characteristics and the obtained effects. In absence of the desired effect, treatment will be repeated during 5 consecutive days at most.
Patients will be followed-up clinically and electrographically. In case of therapeutic success, the treatment can be repeated over time when seizures reoccur. 2. Objectives:
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Epilepsia partialis continua or refractory status epilepticus
- •Prior investigations (EEG, MRI...) show a well-defined neocortical epileptogenic focus
- •Informed consent signed by the patient or his/her legal representative
排除标准
- •Pregnancy, short-term birth wish or childbearing age without adequate birth control
- •Intracranial metal hardware (excluding dental filling): surgical clips, shrapnell, electrodes under the stimulation area
- •Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants or deep brain stimulation (DBS)
结局指标
主要结局
Seizure diary
时间窗: Throughout the study, lasting approximately 4 weeks
Self-reported seizure frequency throughout the study as a measure of clinical efficacy.
Electrographic epileptiform activity
时间窗: Throughout the study, lasting approximately 4 weeks, with assessment before treatment (if possible) and after treatment
Interictal or continuous epileptiform activity on EEG is assessed throughout the study as a measure of clinical efficacy.
Neurological examination
时间窗: Throughout the study, lasting approximately 4 weeks
Neurological examination assessing consciousness and other cortical functions that are potentially disturbed by the EPC or SE (eg. motor function, speech,...) is performed throughout the study as a measure of clinical efficacy.
次要结局
- Duration of the clinical effect(Throughout the study, lasting approximately 4 weeks or as long as the outlasting effect lasts)
- Adverse events(Throughout the study, lasting approximately 4 weeks)
研究者
Prof. Dr. Kristl Vonck
Prof. Dr. Boon
University Hospital, Ghent