Seizure Detection and Warning System in Epilepsy Patients

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

This is a phase III, pilot, prospective study of an Electromyography (EMG) based seizure detection system for detecting Generalized Tonic-Clonic Seizures (GTCS) in the home.

Study Overview

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

Detailed Description

The Brain Sentinel™ Seizure Detection and Warning System is intended for monitoring children and adults with a history or significant risk of generalized tonic-clonic seizures in the home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs, and for continuous monitoring (night time or any other time of day) of individuals due to their history or risk of generalized tonic-clonic seizures. The device will withstand activities of daily living including showers and sleep.

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Jose' E. Cavazos

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

Subjects with a history of 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. Male or female between the ages of 2-99.
3. Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).
4. Be able to tolerate wearing the device on the upper arm.
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. The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm)
3. Pregnant female
4. Subject/Caregiver is unable to provide consent.
5. Subject/Caregiver is not competent to follow home study procedures.
6. The subject is homeless or in a home without a power supply.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Brain Sentinel Seizure Detection and Warning System; To test the usability of the Brain Sentinel Seizure Detection and Warning System(also known as the SPEAC system) in a patient home setting.	Device: Brain Sentinel Seizure Detection and Warning System; A sEMG based automated seizure detection and warning system worn on the biceps; Other Names: SPEAC System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test the function of the system including ability to acquire EMG signal, analyze and successfully transmit the analysis to the base station, and identify and transmit all alert conditions.	The overall usability and technical features will be assessed through questionnaires and surveys as the Seizure Detection and Warning System will be used within a home setting.	up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the accuracy of the EMG based system's log to the subject's seizure diary	Comparison of the subject's seizure diary to the EMG based seizure detection system's seizure logs will help determine overall function.	up to one month

Collaborators and Investigators

• Sponsor: Brain Sentinel
• Investigators: Principal Investigator: Jose E. Cavazos, MD, PhD, Brain Sentinel

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 7, 2017
• Study Completion (Actual): July 7, 2017

Study Registration Dates

• First Submitted: February 13, 2015
• First Submitted That Met QC Criteria: September 18, 2015
• First Posted (Estimate): September 21, 2015

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: July 10, 2017
• Last Verified: July 1, 2017

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: 3.01P

Plan for Individual participant data (IPD)

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