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

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.

Study Overview

• Status: Terminated
• Conditions: Epilepsy
• Intervention / Treatment: Device: Brain Sentinel Seizure Detection and Information System

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.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People with a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brain Sentinel
• Collaborators: Nationwide Children's Hospital
• Investigators: Principal Investigator: Anup Patel, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: March 28, 2016
• First Submitted That Met QC Criteria: April 26, 2016
• First Posted (Estimate): April 27, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: GTC Seizures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: HE-1.5-03.2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No