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

NCT02752373 | Terminated

• 1 other identifier: HE-1.5-03.2016
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

GTC Seizures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

Interventions

Brain Sentinel Seizure Detection and Information System DEVICE

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

• Age: 2 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brain Sentinel: lead
• Nationwide Children's Hospital: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Anup Patel, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 27, 2016
• Study Start: May 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 20, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)