Generalized Seizure Detection And Alerting In The EMU With The Empatica Embrace Watch And Smartphone-Based Alert System

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).

Inclusion Criteria:

- Male and female patients with a history of convulsive seizure (as defined above) who
are admitted to a hospital for routine vEEG monitoring related to seizures. Patients
who are expected to have a convulsive seizure during their monitoring based on
interpretation of clinical history.

Exclusion Criteria:

- Patients who are not expected to have their typical convulsive seizure during the
course of their hospital admission (i.e. expected reduction due to anti-epileptic
drugs during hospital admission).

- Women who are pregnant.

- Patients who are known or suspected to have a history of PNES only.

- Patients with known allergic reactions to nickel or stainless steel

- Infants who were born pre-term and may not have fully developed skin