Overview

This trial is active, not recruiting.

Conditions epilepsy, generalized tonic-clonic seizures
Treatment brain sentinel seizure detection and warning system
Phase phase 3
Sponsor Brain Sentinel
Start date April 2015
End date September 2017
Trial size 13 participants
Trial identifier NCT02371200, GTC-1.5-09.2015

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
This study will compare accuracy of seizure detection by the study device to simultaneously collected data of seizure detection by video EEG.
brain sentinel seizure detection and warning system SPEAC 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.

Primary Outcomes

Measure
Sensitivity of the Seizure Detection System
time frame: up to 1 month

Eligibility Criteria

Male or female participants from 2 years up to 99 years old.

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.

Additional Information

Official title 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
Principal investigator Charles Szabo, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Brain Sentinel.