An interventional study of REMI in Epilepsy, sponsored by Epitel, Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2024-01-25.
Sponsored by Epitel, Inc. · Not applicable, Interventional, and Diagnostic
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:
Participants will wear REMI and conventional EEG electrodes at the same time.
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 129 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Epitel, Inc. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
REMI EEG is as Diagnostically useful as conventional EEG at monitoring patients with suspected seizure events.
Diagnostic Test: REMI
Diagnostic monitoring
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.)
Time frame: Through the length of time that a patient is actively monitored using both REMI and a full electroencephalograph (up to 24 hours).
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: Time Frame: Through the time of sensor placement for both REMI sensors and a full electroencephalograph (approximately up to one hour).
Plan to share: Yes — Epitel will make this highly-valuable data set available to the wider academic community. This could be done by posting appropriate data on the Epilepsy Ecosystem website: https://www.epilepsyecosystem.org/ All data collection is performed using the same Epilog Data Dictionary across clinical sites. Each PI and Study Coordinator is trained on the data dictionary reporting. This dictionary follows the Common Data Elements for Epilepsy Mobile Health Systems for which Epitel was a contributing member. The common data elements are meant to standardize to the extent possible all data collection, reporting, and analysis in the epilepsy mobile health space.
Supporting information: Study protocol
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Epitel, Inc.