Epilepsy, Generalized Tonic-Clonic Seizures
Conditions
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.
Interventions
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.
Sponsors
Brain Sentinel
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the Seizure Detection System | 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. |
Countries
United States
Outcome results
None listed