Remote EEG Device for Identification of Risk for Neonatal Seizures

Pilot Study on the Use of a Wearable Remote Electroencephalography Device to Identify Neonates at Risk for Neonatal Seizures and Status Epilepticus

The purpose of this study is to see if the use of wireless brain wave monitoring can be helpful for newborns and help their medical providers identify seizures earlier and to monitor for the risk for seizures.

Study Overview

• Status: Not yet recruiting
• Conditions: Neonatal Encephalopathy
• Intervention / Treatment: Device: Epilog device

Detailed Description

Our goals are to evaluate the effectiveness of the Epilog device in identification of neonates who are at risk for seizures and need formal EEG monitoring or cooling. The current process for these patients would be transfer from Rochester Methodist Hospital to the St. Mary's level 3 NICU for EEG monitoring. Given that in case of neonatal encephalopathy, there is 6-hour window in which to make the critical decision of whether to initiate therapeutic hypothermia or not, rapid access to EEG data is crucial. We would like to perform a pilot study on use of wireless EEG technology in neonates with mild neonatal encephalopathy and neonates with spells to see if this device can be used to determine the risk for neonatal seizure and need for escalation of care and full scalp EEG.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 28 days old or less (postnatal age)
• Neonatal encephalopathy as judged by clinical team or symptoms concerning for subtle seizures
• Patient currently in level 1 newborn nursery or level 2 or 3 NICU

Exclusion Criteria:

• Medical comorbidity which would result in prolonged need for sedation
• Prolonged EEG monitoring is medically indicated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote EEG monitoring; All subjects will pilot the use of wireless EEG technology in neonates with mild neonatal encephalopathy and neonates with spells to see if this device can be used to determine the risk for neonatal seizure and need for escalation of care and full scalp EEG	Device: Epilog device; Pilot the use of wireless EEG technology in neonates with mild neonatal encephalopathy and neonates with spells to see if this device can be used to determine the risk for neonatal seizure and need for escalation of care and full scalp EEG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness of the Epilog device in identification of neonates who are at risk for seizures and need formal EEG monitoring or cooling	Total number of neonates that Epilog device identifies as requiring formal EEG monitoring	Approximately 2 to 72 hours
Evaluate time to formal long-term EEG monitoring in neonates monitored with the Epilog device compared to a historical control cohort of neonates undergoing EEG evaluation.	Time from initiation of monitoring with Epilog device to monitoring completion or conversion to formal prolonged EEG monitoring.	Approximately 2 to 72 hours

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2024
• Primary Completion (Anticipated): January 1, 2026
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Seizures; Brain Diseases
• Other Study ID Numbers: 21-006001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes