NCT03484598Unknown不适用
Clinical Utility of the SPEAC® System: A Case Series
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- Compare Seizure Frequency
研究概览
简要总结
The primary objective is to collect preliminary data related to the clinical utility of the SPEAC System in patients with a history of motor seizures. This trial is primarily an observational investigation. This protocol describes a series of observational case studies. Each case study is intended to be interpreted independent from the other case studies. Self-reported seizure frequency will be compared to observed seizure frequency using the SPEAC System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a reported history of motor seizures (epileptic or not or unknown) with upper extremity motor involvement.
- •The subject's first reported seizure must be within the last 5 years.
- •Male or Female between the ages 22 and
- •If female and of childbearing potential, subject must agree to not become pregnant during the trial.
- •Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
- •Subject or Primary Caregiver must be competent to follow all study procedures.
- •Subject must be willing to use the Seizure Monitoring and Alerting System for a long period of time (up to 90 days), for a minimum of 30 hours/ week.
排除标准
- •The subject cannot be pregnant, or nursing.
- •The subject cannot be sensitive or allergic to adhesives or tapes.
研究组 & 干预措施
SPEAC Treatment Arm
Experimental
All study participants will be provided with a SPEAC System to use in their home environment.
干预措施: SPEAC System (Device)
结局指标
主要结局
Compare Seizure Frequency
时间窗: 1 year
We will compare self-reported seizure frequency to the seizure frequency measured by the SPEAC System.
次要结局
未报告次要终点
研究者
研究点 (3)
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