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

Last updated: August 26, 2024
Sponsor: Epitel, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Treatment

Epitel's™ Remote EEG Monitoring System's (REMI™)

Clinical Study ID

NCT06027749
REMI-23-01
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 provideconsent,

  • 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 30days), for a minimum of 20 hours/day.

Exclusion

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 Design

Total Participants: 65
Treatment Group(s): 1
Primary Treatment: Epitel's™ Remote EEG Monitoring System's (REMI™)
Phase:
Study Start date:
October 13, 2023
Estimated Completion Date:
June 01, 2025

Study 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.

Connect with a study center

  • University of South Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29407
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.