Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To demonstrate safety and effectiveness of the Embrace device in identifying convulsive seizures (CS) and notifying a caregiver during patient hospitalization at an epilepsy monitoring unit (EMU).
To demonstrate safety and effectiveness of the Embrace device in identifying convulsive seizures (CS) and notifying a caregiver during patient hospitalization at an epilepsy monitoring unit (EMU).
Subjects will be fit with an Embrace device upon admittance into the EMU. The Embrace system will be used in conjunction with the EMU standard care practices to monitor the subject during the subject's stay. EMU standard care practices will not be impacted by the Embrace system, but rather the Embrace will be used to supplement the EMU monitoring. The events detected by Embrace will later be compared to the gold standard results of the video EEG.
A convulsive seizure (CS) is defined for the purpose of this study as any seizure with non-facial motor activity involving one or both upper and/or lower extremities that has repetitive motor activity (rhythmic motor movements).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects | Other | This is a single arm study With a device intervention of Additional Seizure Monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional Seizure Monitoring | Device | Embrace could offer an additional layer of seizure monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Video-EEG to Embrace System | Lower bound of 95% confidence interval of the positive percent agreement (PPA) greater than 70%, as determined in comparison to Video-EEG adjudicated by 3 independent expert reviewers. A majority rules approach is used to identify convulsive seizures. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Alarm System Comparison | Lower bound of 95% confidence interval of the positive percent agreement (PPA) greater than 70%, as determined in comparison to standard alarm system available in EMU. | 6 months |
| False Alarm Rate Tolerability |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rosalind W Picard, Sc.D. | Empatica, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Medical Center | New York | New York | 10016 | United States | ||
| Ospedale Pediatrico Bambino Gesù - Department of Neuroscience, Neurology Unit |
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
70% of the EMU staff that use the Embrace consider the false alarm rate to be neutral or better in tolerability based on a survey.
| 6 months |
| Patient Care Improvement Measure | Embrace maintains or improves the level of patient care, as defined by a survey given to the EMU staff. | 6 months |
| Embrace System Usability | Usability of the device perceived by the users (Patients and EMU staff). | 6 months |
| Roma |
| 00165 |
| Italy |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |