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

NCT ID: NCT06027749

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-13
• Study Completion Date: 2025-06-01

Brief 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.

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.

Conditions

Epilepsy; Seizures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

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

Ambulatory electroencephalography (EEG) monitoring

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Epitel, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of South Florida

Tampa, Florida, United States

Site Status: RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: ENROLLING_BY_INVITATION

Countries

United States

Facility Contacts

Marina Azevedo, BSc

Role: primary

azevedom@usf.edu

813-250-2323

Ana Omura, BSc

Role: backup

aomura@usf.edu

813-259-8524

Other Identifiers

REMI-23-01

Identifier Type: -

Identifier Source: org_study_id