Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients

A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System (System Version 1.5) in Epilepsy Patients

Prospective study of an electromyography (EMG) based seizure detection and warning system for detecting generalized tonic-clonic (GTC) seizures.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Generalized Tonic-Clonic Seizures
• Intervention / Treatment: Device: Brain Sentinel Seizure Detection and Warning System

Detailed Description

This study "A Pivotal, Phase III Trial of Detecting generalized tonic-clonic seizures with a Seizure Detection and Warning System in Epilepsy Patients " is a phase III, pivotal, prospective study of an electromyography (EMG) based seizure detection and warning system (tentatively named Brain Sentinel™ Seizure Detection System) for detecting generalized tonic-clonic (GTC) seizures. The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity. This is to facilitate a faster intervention to the GTC seizure, and to more accurately document GTC seizure frequency in a home, skilled nursing, or inpatient setting.

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • San Antonio, Texas, United States, 78229
      • University 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

Children and Adults with GTC seizures, either primary GTC or partial onset seizures with secondary generalization

Description

Inclusion Criteria:

1. Subject has a 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 2-99.
4. Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).
5. If female and of childbearing potential, has a negative pregnancy test.
6. 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.
7. Subject and/or Primary Caregiver must be competent to follow all study procedures.
8. Is able to read, speak, and understand English.

Exclusion Criteria:

1. Does not have a documented history of generalized seizures.
2. 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.
3. Intracranial EEG electrodes are being used
4. The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm).
5. Pregnant female.
6. Subject/Caregiver is unable to provide consent.

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
Brain Sentinel Seizure Detection and Warning System; 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 and Warning System; The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity.; Other Names: SPEAC System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the Seizure Detection System	The primary outcome measure for this clinical trial will be the sensitivity of the Brain Sentinel™ Seizure Detection Systems ability to detect GTC seizure activity in comparison to a Neurologist independent review of vEEG collected in an epilepsy monitoring unit.	up to 1 month

Collaborators and Investigators

• Sponsor: Brain Sentinel
• Investigators: Principal Investigator: Charles Szabo, MD, University Health System of San Antonio

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: February 13, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): February 25, 2015

Study Record Updates

• Last Update Posted (Actual): July 10, 2018
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: July 1, 2018

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: GTC-1.5-09.2015

Plan for Individual participant data (IPD)

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