Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System. (REMI)

Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With REMI.

The goal of this clinical trial is to test Epitel's™ Remote EEG Monitoring System's (REMI™) ability to record electroencephalography (EEG) of seizure events in an ambulatory setting for extended periods (14 - 28 days) in patients presenting with questionable seizure characterization. The main questions it aims to answer are: • Can more seizure events be recorded in fourteen (14) days than can be recorded in three (3) days? • Do treating clinicians find clinical value in extended fourteen (14) - twenty-eight (28) days of EEG? Participants will wear a portable EEG device (REMI) for fourteen (14) to twenty-eight (28) days in their home/community setting.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Seizures
• Intervention / Treatment: Device: Epitel's™ Remote EEG Monitoring System's (REMI™)

Detailed Description

This is a prospective study to quantify Epitel's™ Remote EEG Monitoring System's (REMI™) ability to record electroencephalography (EEG) of seizure events in an ambulatory setting for extended periods (14 - 28 days). Patients presenting with questionable seizure characterization that are scheduling a conventional at home ambulatory EEG (Amb EEG) and who meet the study inclusion and exclusion criteria will be prescribed a REMI system.

The purpose of this study is to demonstrate that the REMI system is able to record EEG data that clinicians can use to identify ictal events over extended periods, and that extended clinical EEG data is valuable in the diagnosis and treatment of seizure related symptoms.

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Recruiting
      • University of South Florida
      • Principal Investigator: Salim Benbadis, MD
      • Contact: Marina Azevedo, BSc; Phone Number: 813-250-2323; Email: azevedom@usf.edu
      • Contact: Ana Omura, BSc; Phone Number: 813-259-8524; Email: aomura@usf.edu
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Enrolling by invitation
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients have a reported history of seizures (epileptic, non-epileptic, or unknown),
• Have a minimum reported seizure rate of one every two weeks,
• Are prescribed an ambulatory EEG study as part of routine care,
• Is Male or Female between the ages of 18 and 70,
• Can understand and sign written informed consent, or have a legal guardian provide consent,
• The Patient (or Primary Caregiver) must be competent to follow all study procedures,
• The Patient must be willing to use the System for a prolonged period (up to 30 days), for a minimum of 20 hours/day.

Exclusion Criteria:

• Is sensitive or allergic to medical acrylics, silicones, or hydrogels,
• Is enrolled in another investigational drug or device trial,
• Is homeless or in a home without a power supply, or
• Cannot read, speak, or understand English (and does not have a translator).

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ictal Events Identified in fourteen (14) days.	Epileptiform seizure activity as identified by three independent board-certified epileptologists assessing data collected by REMI. The number of seizures identified in the first three days will be compared to the number of seizures identified during days one (1) to fourteen (14).	Fourteen (14) days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extended Use	Epileptiform seizure activity as identified by three independent board-certified epileptologists assessing data collected by REMI. The number of seizures identified in the first fourteen (14) days will be compared to the number of seizures identified during all twenty-eight (28) days.	Twenty-eight (28) days

Collaborators and Investigators

• Sponsor: Epitel, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: EEG Monitoring
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures
• Other Study ID Numbers: REMI-23-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No