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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Epilepsy
- Sponsor
- Brain Sentinel
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Sensitivity of the Seizure Detection System
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Prospective study of an electromyography (EMG) based seizure detection and warning system for detecting generalized tonic-clonic (GTC) seizures.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
- •Is being admitted to a hospital for routine vEEG monitoring related to seizures.
- •Male or female between the ages of 2-
- •Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).
- •If female and of childbearing potential, has a negative pregnancy test.
- •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.
- •Subject and/or Primary Caregiver must be competent to follow all study procedures.
- •Is able to read, speak, and understand English.
Exclusion Criteria
- •Does not have a documented history of generalized seizures.
- •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.
- •Intracranial EEG electrodes are being used
- •The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm).
- •Pregnant female.
- •Subject/Caregiver is unable to provide consent.
Outcomes
Primary Outcomes
Sensitivity of the Seizure Detection System
Time Frame: up to 1 month
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.