A Pilot Study of the Safety of a Novel Helmet Design in Patients With Seizures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Part 1: Number of Successful Deployments
研究概览
简要总结
This is a two-part study that aims to determine the reliability and safety of the use of the Hövding inflatable helmet in seizures, as evidenced by the deployment of the helmet during seizures, and qualitative patient reporting.
详细描述
Part 1: 4 healthy volunteers will fall from a standing position onto a padded surface to evaluate for consistent helmet deployment from a standing position. Part 2: up to 20 patients with drug resistant epilepsy who do not use existing head-protective devices will be enrolled and assigned to first enter "helmet" or "no helmet" groups. When assigned to the "helmet" group, patients will wear the helmet until deployment during a seizure or up to 3 months. Subjects will complete questionnaires about their seizures including any injuries sustained, post concussive symptom questionnaire, and the circumstances of inflation. Patients will return to site after helmet deployment. While assigned to the "no helmet" group, patients will complete the same questionnaires, except those relating to helmet inflation. We will compare circumstances, injuries, and post concussive scales in seizures resulting in falls occurring while the helmet was worn versus seizures resulting in falls occurring while the helmet was not being worn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-60 at the time of enrollment.
- •Have neck circumference between 34 and 42 cm.
- •Can understand and provide written informed consent.
- •Must be competent to follow all study procedures.
- •Able to read, speak, and understand English.
- •Have at least one seizure every 6 months that might result in a fall (Generalized Tonic Clonic Seizure, Atonic Seizure, and/or Complex Partial Seizure resulting in a fall).
- •Has a seizure frequency of at least once per 2 months.
- •Be between ages 18-65 at the time of enrollment.
- •Have neck circumference between 34 and 42 cm
- •Must live in a home with electrical power supply.
- •If female and of childbearing potential, has negative pregnancy test at the beginning of the study and willing to use appropriate birth control for the duration of the study.
- •Can understand and sign written informed consent.
- •Must be competent to follow all study procedures.
- •Able to read, speak, and understand English.
排除标准
- •Subject is currently pregnant
- •Patient already wears a helmet for seizure safety.
- •Subject is pregnant, planning to become pregnant during the study, or is unwilling to use an appropriate form of birth control during the study.
研究组 & 干预措施
Part 2: No Helmet
After a screening period, 10 subjects with drug resistant epilepsy will first be assigned to not wear an inflatable helmet. Subjects will fill out questionnaires about their seizures and injuries. After approximately 3 months, patients will crossover to the "helmet" group.
Part 2: Helmet
After a screening period, 10 patients with drug resistant epilepsy will first be assigned to wear one Hövding inflatable helmet in their daily lives. Subjects will fill out questionnaires about their seizures, injuries, and the circumstances of inflation when it occurs. After experiencing a seizure resulting in a fall or any helmet deployment, patients will crossover to the "no helmet" group. If no seizure resulting in fall occurs in 3 months, participation will end.
干预措施: Hövding inflatable helmet (Device)
结局指标
主要结局
Part 1: Number of Successful Deployments
时间窗: 1 day
3 out of 4 successful deployments was set as a criteria to allow advancement to part 2.
Part 2: Helmet Deployment Questionnaire
时间窗: 6 months
Differences in Helmet Deployment Questionnaire responses will be compared between subjects wearing helmets during a seizure, and subjects not wearing helmets during a seizure.
次要结局
- Rivermead Post Concussive Scale(6 months)
- Seizure Questionnaire(6 months)
- Injury-related Medical Record Review(6 months)
- Helmet Deployment Questionnaire (Seizure/Not Seizure)(6 months)
研究者
Michael A. Gelfand, MD, PhD
Assistant Professor of Clinical Neurology
University of Pennsylvania