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.
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.
Study Type
OBSERVATIONAL
Enrollment
5
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.
Nationwide Children's Hospital
Columbus, Ohio, United States
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.
Time frame: 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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months prior to receiving the device and at 2 months and after 6 months of device use