A Health Economic Study Evaluating the Brain Sentinel® GTC Seizure Detection and Information Systems Impact on Epilepsy and Healthcare Utilization
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Evaluate the change in associated healthcare costs for patients with a GTC seizure detection and information system
研究概览
简要总结
This is an open label prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure detection system for detecting Generalized Tonic-Clonic (GTC) Seizures.
详细描述
The Brain Sentinel® GTC Seizure Detection and Information System is an ambulatory system designed to continuously monitor and perform real-time analysis of surface electromyography (sEMG) data to detect GTC seizures and to provide an alarm to alert caregivers within 30 seconds of bilateral, appendicular, tonic extension that a seizure is occurring. The System is for recording and storing sEMG data, which is subsequently reviewed by a trained healthcare professional in the outpatient clinical setting. The Brain Sentinel® GTC Seizure Detection and Information System is intended for real time monitoring of pediatric and adult patients who have an arm circumference ranging from at least 16 cm to no greater than 51 cm at the biceps. It may be used in the home or healthcare facilities for real-time monitoring during the day, night, or for continuous monitoring, including during the titration of, or the withdrawal from anti-epileptic drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization
- •Male or female greater than 2 years of age
- •Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 16-51 cm)
- •Be able to tolerate wearing the device on the upper arm
- •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 and/or Primary Caregiver must be competent to follow all study procedures.
- •Is able to read, speak and understand English
- •At least 2 or more Emergency Department visits in the previous 12 months for seizure related care
排除标准
- •The subject is homeless or in a home without a power supply.
- •The subject is allergic to adhesives or any component of the electrode patch assembly.
- •The subject self-reports that she is pregnant or planning to become pregnant while using the device.
结局指标
主要结局
Evaluate the change in associated healthcare costs for patients with a GTC seizure detection and information system
时间窗: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate the change in associated healthcare costs for patients 12 months prior as compared to 2 months and each 6 months of system use and compared to a similar population of epilepsy patients.
次要结局
- Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change of the number of Emergency Department Visits(12 months prior to receiving the device and at 2 months and after 6 months of device use)
- Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change in number of inpatient hospitalizations(12 months prior to receiving the device and at 2 months and after 6 months of device use)
- Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change in number of EEGs(12 months prior to receiving the device and at 2 months and after 6 months of device use)
- Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change in number of Long Term Video EEG Monitoring (LTM)(12 months prior to receiving the device and at 2 months and after 6 months of device use)
- Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change in number of outpatient clinic visits in patients(12 months prior to receiving the device and at 2 months and after 6 months of device use)
- Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system by assessing the change in seizure frequency for each type (reported as per month)(12 months prior to receiving the device and at 2 months and after 6 months of device use)
- Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change in number of no-shows and/or patient cancellations(12 months prior to receiving the device and at 2 months and after 6 months of device use)
- Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system by assessing change in epilepsy etiology (including, but not limited to a new diagnosis of psychogenic non-epileptic spells)(12 months prior to receiving the device and at 2 months and after 6 months of device use)
- Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system by assessing clarification of diagnosis(12 months prior to receiving the device and at 2 months and after 6 months of device use)
- Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system by assessing change in epilepsy treatment(12 months prior to receiving the device and at 2 months and after 6 months of device use)
- To evaluate the impact of epilepsy on families and patients ages > 11 receiving Brain Sentinel® System(12 months prior to receiving the device and at 2 months and after 6 months of device use)
- To evaluate the change in quality of life for patients ages > 11 receiving Brain Sentinel® System(12 months prior to receiving the device and at 2 months and after 6 months of device use)