Seizure Detection and Warning System for Epilepsy Patients

A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients

The seizure detection and warning system is an ambulatory system designed to monitor and analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert caregivers that a seizure is occurring.

Study Overview

• Status: Unknown
• Conditions: Epilepsy
• Intervention / Treatment: Device: Brain Sentinel Seizure Detection Device and Warning System

• Study Type: Observational
• Enrollment (Actual): 239

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78232-1399
      • Brain Sentinel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adolescent epilepsy patients with a history of generalized tonic-clonic seizures either primary GTC or partial onset seizures with second generalization.

Description

Inclusion Criteria:

1. Subject has a suspected history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
2. Is being admitted to a hospital for routine vEEG monitoring related to seizures.
3. Male or female between the ages of 13-21.
4. If female and of childbearing potential, has a negative pregnancy urine test, and must also not be nursing.
5. 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.
6. Subject and/or Primary Caregiver must be competent to follow all study procedures.
7. Is able to read, speak, and understand English or has a LAR that does so.
8. Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study.

Exclusion Criteria:

1. Has not had a GTC seizure within the last year AND is not expected to have a reduction of anti-epileptic drugs during their hospital admission.
2. Intracranial EEG electrodes are being used.
3. The subject is allergic to adhesives or any component of the electrode patch assembly

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Epilepsy Patients; This study will compare accuracy of seizure detection by the study device to simultaneously collected data of seizure detection by video EEG.	Device: Brain Sentinel Seizure Detection Device and Warning System; The Brain Sentinel Seizure Detection Device and Warning System is designed to monitor Epilepsy patients and alerts caregivers that a GTC seizure is occurring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome is accuracy of device to detect GTC seizures when compared to video EEG.	The primary objective of the research is to determine the ability of the Brain Sentinel Seizure Detection System to accurately detect GTC seizures in comparison to the recognized "gold standard" for seizure detection, video Electroencephalography (vEEG).The primary endpoint will be the sensitivity of GTC seizure detection (defined as within 30 seconds of motor manifestation via vEEG analysis) in a hospital setting.	less than 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of study device to self reporting of seizures using a seizure diary.	The secondary objective is to assess the operation of the Brain Sentinel Seizure Detection System when used in the subject's home and to compare the GTC seizure reporting of the device to a standard seizure diary completed by the subject/caregiver.	Less than 1 month

Collaborators and Investigators

• Sponsor: Brain Sentinel
• Investigators: Principal Investigator: Dileep Nair, MD, The Cleveland Clinic; Principal Investigator: Jose' E Cavazos, MD, PhD, Brain Sentinel; Principal Investigator: Dennis Dlugos, MD, Children's Hospital of Philadelphia; Principal Investigator: Jonathan Halford, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: June 5, 2013
• First Submitted That Met QC Criteria: June 7, 2013
• First Posted (Estimate): June 11, 2013

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: BS-0421

Plan for Individual participant data (IPD)

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