Seizure Detection and Warning System in Epilepsy Patients

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555410
• Other study ID #: 3.01P
• Status: Completed
• Phase: N/A
• First received: February 13, 2015
• Last updated: July 10, 2017
• Start date: January 2013
• Est. completion date: July 7, 2017

Study information

• Verified date: July 2017
• Source: Brain Sentinel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 7, 2017
• Est. primary completion date: July 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Generalized Tonic-Clonic Seizures
• Seizures

Intervention

Device:
• Brain Sentinel Seizure Detection and Warning System
A sEMG based automated seizure detection and warning system worn on the biceps

Locations

Country	Name	City	State
United States	Jose' E. Cavazos	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brain Sentinel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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