High Definition Cathodal Transcranial Direct Current Stimulation for Treatment of Refractory Partial Onset Epilepsy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- EEG monitoring
研究概览
简要总结
High-Definition transcranial Direct Current Stimulation (HD tDCS)
Genuine cathodal HD-tDCS will be delivered through High-Definition electrodes that will be arranged on the skull according to a 4x1-ring configuration with the central cathodal electrode placed over the identified target and surrounding return electrodes forming approximately a 5-cm radius ring.
Aim: To explore whether a novel form of tDCS can be a safe noninvasive treatment that could potentially suppress seizures in refractory partial-onset epilepsy.
详细描述
1 Introduction This document is a protocol for a human research study. This study is to be conducted in accordance with US government research regulations, and applicable international standards of Good Clinical Practice, and institutional research policies and procedures.
1.1 Background Focal Status epilepticus (FSE) is characterized by a prolonged, self-sustaining, and anatomically discrete seizures that last longer than one hour (at times as long as days or weeks) and that are associated with a definable neurologic behavior (Schomer 2005). Symptoms in FSE can vary according to the function of the brain area affected, can vary in discharge, and can be as simple as a repetitive limb movement as seen in epilepsy partialis continua (EPC), or as subtle as an inability to write a command or name an object. Prevalence of EPC is estimated to be 1 per one million (Cockerell 1996). A large proportion of FSE episodes are resultant from acute neurologic insult such as stroke or hemorrhage, although, at times, the cause of FSE remains unknown. FSE treatment should commence promptly upon its recognition using predefined treatment protocols. The goal of treatment is the rapid termination of the seizure to minimize the acute and chronic effects of this emergency and to allow for the prompt assessment and management of the underlying precipitant (Loddenkemper 2011).
Furthermore, patients may suffer from refractory partial onset epilepsy, and suffer from frequent seizures despite maximizing medical therapy, which may place them at higher risk of having FSE or EPC.
Yet many instances of FSE, EPC, and refractory partial onset epilepsy which is resistant to pharmacotherapy, and require nonpharmacologic treatment.
Accordingly, the investigatorspropose a Phase-1 clinical trial to test the safety and tolerability of High Definition Transcranial Direct Current Stimulation (HD-tDCS), a -noninvasive technology with the capacity to suppress seizures in patients with frequent partial onset seizures, and eventually FSE or EPC. The investigators plan to use the Soterix HD-tDCS device. The device is a current-controlled source which generates a constant output current. In other words, the device automatically maintains constant output current by decreasing or increasing the output voltage needed as long as it does not surpass device compliance voltage, which provides an added safety measure.
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
- 9 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 9 to 65 years
- •Focal-onset neocortical epilepsy (as determined by semiology, EEG, and/or MRI)
- •Frequent (>50% of EEG record) focal epileptiform discharges on EEG and/or frequent (defined as average of ≥2 daily seizures) focal-onset clinical seizure, refractory to medical anti-epileptic treatment. For the purposes of this study, any patient who has been treated with three or more AEDs at therapeutic doses for at least four weeks per drug will be considered medically refractory.
- •Seizure onset must be localizable by clinical semiology, EEG or MRI.
- •Subjects or guardians must be competent to sign an informed consent indicating awareness of the investigational nature of this study, treatment, benefits and procedures involved.
排除标准
- •Age over 65 years or under 9 years.
- •Implanted cardiac pacemakers, cochlear implants, implanted medication pump, or intracardiac line.
- •Within past six months, history of active heart disease, stroke, respiratory disease, or increased intracranial pressure such as after infarction or trauma.
- •Pregnant women. A urine test will be conducted on all post-menarchal females of childbearing age and potential to verify they are not pregnant.
- •History of significant head trauma (loss of consciousness >10 minutes) within the past 6 months.
- •Currently taking tricyclic anti-depressants, bupropion, or neuroleptic medications.
- •Intracranial metal (e.g., cortical stimulator, deep brain stimulator, intraventricular catheter) within 4 cm of optimal stimulation site. Location of cranial metal (e.g. skull screws) should be carefully documented.
- •Neurodegenerative disease.
- •Radiographic or electrophysiologic evidence for deep structure seizure focus (e.g., mesial temporal sclerosis or periventricular heterotopia)
- •Inability to remain seated and relatively still for 30 minutes.
- •Benign rolandic epilepsy.
研究组 & 干预措施
HD Transcranial Direct Stimulation
Genuine cathodal HD-tDCS approximately 2mA will be delivered through High-Definition electrodes that will be arranged on the skull according to a 4x1-ring configuration with the central cathodal electrode placed over the identified target and surrounding return electrodes forming approximately a 5-cm radius ring.
干预措施: HD Transcranial Direct Stimulation (Device)
结局指标
主要结局
EEG monitoring
时间窗: 30 minutes
次要结局
未报告次要终点