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

NCT06027749 | Recruiting FDA Device

• 1 other identifier: REMI-23-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Epilepsy; Seizures

Keywords

EEG Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Extended Use

  Twenty-eight (28) days

Interventions

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

Ambulatory electroencephalography (EEG) monitoring

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Epitel, Inc.: lead

Study Sites (2)

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29407, United States

ENROLLING BY INVITATION

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective Cohort

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: October 13, 2023
• Primary Completion: March 30, 2025
• Study Completion: June 1, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)