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

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ClinicalTrials.gov Identifier: NCT06027749
Recruitment Status : Recruiting
First Posted : September 7, 2023
Last Update Posted : October 25, 2023
Sponsor:
Information provided by (Responsible Party):
Epitel, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Epilepsy Seizures Device: Epitel's™ Remote EEG Monitoring System's (REMI™) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective Cohort
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With REMI.
Actual Study Start Date : October 13, 2023
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arms and Interventions
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Intervention Details:
  • Device: Epitel's™ Remote EEG Monitoring System's (REMI™)
    Ambulatory electroencephalography (EEG) monitoring

Outcome Measures
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Primary Outcome Measures :
  1. Ictal Events Identified in fourteen (14) days. [ Time Frame: 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).


Secondary Outcome Measures :
  1. Extended Use [ Time Frame: Twenty-eight (28) 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 fourteen (14) days will be compared to the number of seizures identified during all twenty-eight (28) days.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06027749


Locations
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United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Marina Azevedo, BSc    813-250-2323    azevedom@usf.edu   
Contact: Ana Omura, BSc    813-259-8524    aomura@usf.edu   
Principal Investigator: Salim Benbadis, MD         
United States, South Carolina
Medical University of South Carolina Enrolling by invitation
Charleston, South Carolina, United States, 29407
Sponsors and Collaborators
Epitel, Inc.
More Information
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Responsible Party: Epitel, Inc.
ClinicalTrials.gov Identifier: NCT06027749    
Other Study ID Numbers: REMI-23-01
First Posted: September 7, 2023    Key Record Dates
Last Update Posted: October 25, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared with other researchers.

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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
Keywords provided by Epitel, Inc.:
EEG Monitoring
Additional relevant MeSH terms:
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Seizures
Nervous System Diseases
Neurologic Manifestations