A Randomized, Sham-controlled Study of the Efficacy of Intersectional Short Pulse (ISP) Stimulation for Seizure Termination
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 主要终点
- Mean duration of seizures detected
研究概览
简要总结
This is a study which seeks to develop a novel therapeutic approach, Intersectional Short Pulse (ISP) stimulation for seizure termination. The device embodiment of ISP is a scalp EEG recording system which also delivers spatially precise electrical stimulation in short pulses to the targeted brain region. The study team has already collected safety and tolerability data in human subjects, demonstrated ISP efficacy in terminating seizures in rodents, and have tested the efficacy of this device to modulate normal human brain activity. Now this study proposes to test the device's efficacy in stopping seizures in a within-subject randomized, sham-controlled study design.
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)
盲法说明
The subject will be blinded to the treatment condition. The study team clinician will be aware of the treatment condition to provide to the clinical team any necessary information for clinical care. Decisions by expert review of EEG on seizure duration will be blinded to treatment condition as well.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experiment 3: Epilepsy patients
- •Inclusion criteria:
- •Adult patients (age 18-65).
- •Fluent in English.
- •Epilepsy patients with poorly controlled (>=2 seizures per week).
- •Focal onset seizures.
- •Seizure onset zone in the mesial temporal or neocortical onset as determined by >2 concordant criteria, without discordant criteria (semiology, MRI Brain, and EEG).
- •Able to give informed consent.
排除标准
- •Patients with skull defects.
- •Patients with implanted neurostimulator or other implanted cerebral hardware.
- •Patients with multifocal onset epilepsy.
- •Patients who are non-verbal or incapable of providing informed consent.
- •Current substance abuse.
- •Pregnancy.
- •Patients with non-MRI compatible implants (for Experiments 2 and 3).
研究组 & 干预措施
Perpheral Stimulation
Sham Stimulation
干预措施: SeizureStop Device (Device)
ISP Stimulation
干预措施: SeizureStop Device (Device)
结局指标
主要结局
Mean duration of seizures detected
时间窗: up to Day 10
次要结局
未报告次要终点