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

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ClinicalTrials.gov Identifier: NCT03207685
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Empatica, Inc.

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).

Condition or disease Intervention/treatment Phase
Epilepsy Device: Additional Seizure Monitoring Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Characterizing Generalized Seizure Detection And Alerting In The Epilepsy Monitoring Unit With The Empatica Embrace Watch And Smartphone-Based Alert System
Actual Study Start Date : June 30, 2017
Actual Primary Completion Date : January 26, 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
All Subjects
This is a single arm study
Device: Additional Seizure Monitoring
Embrace could offer an additional layer of seizure monitoring




Primary Outcome Measures :
  1. Comparison of Video-EEG to Embrace System [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Alarm System Comparison [ Time Frame: 6 months ]
    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.

  2. False Alarm Rate Tolerability [ Time Frame: 6 months ]
    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.

  3. Patient Care Improvement Measure [ Time Frame: 6 months ]
    Embrace maintains or improves the level of patient care, as defined by a survey given to the EMU staff.

  4. Embrace System Usability [ Time Frame: 6 months ]
    Usability of the device perceived by the users (Patients and EMU staff).



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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207685


Contacts
Contact: Chelsea B Trengrove, Ph.D. 6174012963 Ct@empatica.com

Locations
United States, New York
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Jay Jeschke       Jay.Jeschke@nyumc.org   
Principal Investigator: Daniel Friedman, MD         
Italy
Ospedale Pediatrico Bambino Gesù - Department of Neuroscience, Neurology Unit Recruiting
Roma, Italy, 00165
Contact: Paola De Liso, MD    39 0668594011    paola.deliso@opbg.net   
Principal Investigator: Federico Vigevano, MD         
Sponsors and Collaborators
Empatica, Inc.
Investigators
Principal Investigator: Rosalind W Picard, Sc.D. Empatica, Inc.

Responsible Party: Empatica, Inc.
ClinicalTrials.gov Identifier: NCT03207685     History of Changes
Other Study ID Numbers: 2016-002
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Empatica, Inc.:
Epilepsy
Epilepsy Monitoring Unit
EMU
Seizure
Seizure Detection

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms