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To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review during patient hospitalization in an epilepsy monitoring unit (EMU).
To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review, during patient hospitalization in an epilepsy monitoring unit (EMU).
Eligible subjects will be issued an EpiWatch device upon admittance into the EMU. The events detected by the EpiWatch will be compared to TC seizures as determined by epileptologists' interpretation of video-EEG recorded for the subject to determine the effectiveness of EpiWatch in detecting TC seizures. EMU standard care practices will not be modified for subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monitored Subjects | Other | Single arm study of subjects that have been issued an EpIWatch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiological signal monitoring and seizure detection | Device | Data collection and as an adjunct to other methods of seizure monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of video-EEG to EpiWatch Results for PPA | Lower bound of 95% confidence interval of the positive percent agreement (PPA) > 80%, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers. | 6 months |
| Comparison of video-EEG to EpiWatch results for FAR | Upper bound of 95% confidence interval of the false alarm rate (FAR) <.71, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Ambulation Positive Percent Agreement | Estimate the PPA in pediatric participants in ambulation in addition to at rest | 6 months |
| Pediatric Ambulation False Alarm Rate | Estimate the False Alarm Rate in pediatric participants in ambulation in addition to rest |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory L Krauss, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medicine | Baltimore | Maryland | 21205 | United States |
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| ID | Term |
|---|---|
| D004830 | Epilepsy, Tonic-Clonic |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 6 months |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |