Assessment of Remote EEG Monitoring (REMI-EEG) in Pediatric Emergency and Adult Critical Care Units

Epilepsy Clinical Trial

Official title:

Assessment of Remote EEG Monitoring (REMI-EEG) in Pediatric Emergency and Adult Critical Care Units

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05818930
• Other study ID #: EpitelUtah22
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 8, 2023
• Est. completion date: October 2025

Study information

• Verified date: January 2024
• Source: Epitel, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this observational study is to compare clinical utility between Remote EEG Monitoring (REMI) and conventional EEG in patients (6 and older) that are undergoing EEG recording in a hospital as part of their routine clinical care. The main question[s] it aims to answer are: - What is the concurrence of diagnosis made by epileptologist using REMI and full-EEG signals. - What is the proportion of participants experiencing as seizure at the time of sensor placement, compared between REMI sensor placement and full-EEG placement. Participants will wear REMI and conventional EEG electrodes at the same time.

Description:

Epitel has developed Epilog, a wireless wearable EEG sensor capable of transmitting EEG to a recording, display, and review platform called REMI (Remote EEG Monitoring). Epitel's REMI platform consists of the REMI tablet and four Epilog sensors. The REMI tablet requires connection to secure WiFi access, and Emergency Department and Intensive Critical Care's IT to open access to http://remi.epitel.com. The four epilog sensors communicate directly with the REMI tablet via Bluetooth connection. REMI synchronizes four Epilog sensors placed by hospital Emergency Department (ED) or intensive care unit (ICU) staff within minutes of patient arrival, thus allowing patients who are suspected of having encephalopathy to be evaluated quickly and prior to initial treatment. REMI securely transmits EEG data to its cloud server where data are processed in near real time using Persyst® Mobile software. Data can then be remotely reviewed by clinical team members. The objective of this protocol is to demonstrate clinical utility of the Epilog EEG sensors with the REMI monitoring platform in children age 6 through adults in the pediatric emergency department and neurocritical care unit, respectively. Patients meeting entry criteria will be enrolled by a bedside clinical team member who is trained in Epilog sensor placement and use of the REMI platform. All participants will have four Epilog sensors placed, in addition to the standard of care full-EEG. The bedside clinician will be asked to make a "baseline" diagnosis based only on the clinical symptoms.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 129
• Est. completion date: October 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Clinical EEG has been ordered for suspected seizures
• Age 6 years or older

Exclusion Criteria:

• Cannot undergo EEG recordings because of severe head or other injury that prevents EEG recording.
• Transferred immediately for an operation
• Hemodynamically unstable (SBP less than 90 mmHg) at time of EEG placement
• Inability to place four REMI EEG sensors.

Related Conditions & MeSH terms

• Emergencies
• Epilepsy

Intervention

Diagnostic Test:
• REMI
Diagnostic monitoring

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Epitel, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of clinician's diagnostic impression between REMI and conventional electroencephalograph data.	Concurrence of diagnosis made by epileptologist using REMI and full electroencephalograph signals. (I.e., a comparative count of seizure activity identified by an epileptologist using REMI EEG and using conventional EEG.)	Through the length of time that a patient is actively monitored using both REMI and a full electroencephalograph (up to 24 hours).
Secondary	Comparison of time to identify epileptiform EEG signals between REMI and conventional electroencephalograph data.	Proportion of participants seizing at the time of sensor placement, compared between REMI sensor placement and full electroencephalograph placement. (I.e., a count of seizure activity identified by an epileptologist using REMI EEG before conventional EEG is connected.)	Time Frame: Through the time of sensor placement for both REMI sensors and a full electroencephalograph (approximately up to one hour).