NCT03741192尚未招募不适用
Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 主要终点
- Diagnostic Impact Form Questionnaire
研究概览
简要总结
This is an open label, randomized, prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure monitoring and alerting system for Veterans with seizures with upper extremity motor involvement, that are refractory to three or more antiepileptic drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a veteran with a reported history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization.
- •Subjects suspected of experiencing one or more spells per month.
- •Subjects has failed at least 3 anti-epileptic drugs (single or combination).
- •Male or Female between the ages 22 to
- •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 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 prolonged period (up to five months), 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.
- •The subject may not be enrolled in another Clinical Trial.
- •The subject is homeless or in a home without a power supply.
研究组 & 干预措施
Treatment Group
Experimental
SPEAC System
干预措施: SPEAC System (Device)
Standard of Care
No Intervention
结局指标
主要结局
Diagnostic Impact Form Questionnaire
时间窗: Up to 5 months
The physician will complete this questionnaire after each 30 days of device use to determine if information acquired will change the physician's assessment of the patient's seizures and their treatment plan.
次要结局
- VR-12 Survey(5 years)
- VA Administrative Data(5 years)
- Personal Impact of Epilepsy Scale (PIES) Survey(5 years)
研究者
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