Clinical trial NCT02752373: A Health Economic Study Evaluating the Brain Sentinel® GTC Seizure Detection and Information Systems Impact on Epilepsy and Healthcare Utilization
Official title: A Health Economic Study Evaluating the Brain Sentinel® GTC Seizure Detection and Information Systems Impact on Epilepsy and Healthcare Utilization
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Epilepsy
Keywords: GTC Seizures
Lead sponsor: Brain Sentinel
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
First posted: 2016-04-27
Enrollment: 5
Sex: ALL
Minimum age (years): 2
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the change in associated healthcare costs for patients with a GTC seizure detection and information system
timeFrame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Secondary outcomes:
measure: 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
timeFrame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
measure: 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
timeFrame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
measure: 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
timeFrame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
measure: 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)
timeFrame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
measure: 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
timeFrame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
measure: 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
timeFrame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
measure: 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)
timeFrame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
measure: 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)
timeFrame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
measure: Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system by assessing clarification of diagnosis
timeFrame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
measure: Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system by assessing change in epilepsy treatment
timeFrame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
measure: To evaluate the impact of epilepsy on families and patients ages > 11 receiving Brain Sentinel® System
timeFrame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
measure: To evaluate the change in quality of life for patients ages > 11 receiving Brain Sentinel® System
timeFrame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Anup Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: