Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
This trial is active, not recruiting.
|Conditions||epilepsy, generalized tonic-clonic seizures|
|Treatment||brain sentinel seizure detection and warning system|
|Start date||April 2015|
|End date||March 2017|
|Trial size||13 participants|
|Trial identifier||NCT02371200, GTC-1.5-09.2015|
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|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Sensitivity of the Seizure Detection System
time frame: up to 1 month
Male or female participants from 2 years up to 99 years old.
- 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 2-99.
- 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.
- 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.
|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.|
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