A Health Economic Study Evaluating the Brain Sentinel® GTC Seizure Detection and Information Systems Impact on Epilepsy and Healthcare Utilization

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Health Economic Study Evaluating the Brain Sentinel® GTC Seizure Detection and Information Systems Impact on Epilepsy and Healthcare Utilization

Conditions
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Epilepsy

Intervention / Treatment
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* Device: Brain Sentinel Seizure Detection and Information System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Brain Sentinel Seizure Detection and Information System|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the change in associated healthcare costs for patients with a GTC seizure detection and information system | 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. | 12 months prior to receiving the device and at 2 months and after 6 months of device use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The change in number of Emergency Department visits will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use. | 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 | The change in number of inpatient hospitalizations will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use. | 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 | The change in number of EEGs will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use. | 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) | The change in number of Long Term Video EEG Monitoring (LTM) will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use. | 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 | The change in number of outpatient clinic visits in patients will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use. | 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 | The change in number of no-shows and/or patient cancellations will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use. | 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) | Change in seizure frequency for each type (reported as per month) will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use. | 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) | Change in epilepsy etiology (including, but not limited to a new diagnosis of psychogenic non-epileptic spells) will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use. | 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 | Clarification of diagnosis, if applicable, will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use. | 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 | Change in epilepsy treatment will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use. | 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 | Assess data captured on Impact on Families questionnaire collected at baseline, 2 months, and each 6 month time period during use of the device. | 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 | Assess data captured on Quality of Life in Epilepsy questionnaire collected at baseline, 2 months, and each 6 month time period during use of the device. | 12 months prior to receiving the device and at 2 months and after 6 months of device use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GTC Seizures