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

NCT ID: NCT03207685

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2022-01-31

Brief Summary

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).

Detailed Description

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).

Conditions

Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

All Subjects

This is a single arm study With a device intervention of Additional Seizure Monitoring

Group Type: OTHER

Additional Seizure Monitoring

Intervention Type: DEVICE

Embrace could offer an additional layer of seizure monitoring

Interventions

Additional Seizure Monitoring

Embrace could offer an additional layer of seizure monitoring

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Empatica, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rosalind W Picard, Sc.D.

Role: PRINCIPAL_INVESTIGATOR

Empatica, Inc.

Locations

NYU Langone Medical Center

New York, New York, United States

Ospedale Pediatrico Bambino Gesù - Department of Neuroscience, Neurology Unit

Roma, , Italy

Countries

United States; Italy

Other Identifiers

2016-002

Identifier Type: -

Identifier Source: org_study_id