Recruiting

EEG Monitoring

Sponsor:

Epitel, Inc.

Code:

NCT06027749

Conditions

Epilepsy

Seizures

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06027749

Start date

Oct 13, 2023

Status verified date

Aug, 2024

Completion date

Jun 1, 2025

Anticipated

Primary completion date

Mar 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

65 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Interventions

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

Ambulatory electroencephalography (EEG) monitoring

Primary outcome measure

  • Ictal Events Identified in fourteen (14) days. [ Time Frame: Fourteen (14) days ]

Central Contacts and Locations

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Contacts

Marina Azevedo, BSc

813-250-2323azevedom@usf.edu

Ana Omura, BSc

813-259-8524aomura@usf.edu

Principal Investigator:

Salim Benbadis, MD

More Information

Sponsor

Epitel, Inc.

Last update posted

Aug 27, 2024

Last verified

Aug, 2024

Keywords

  • EEG Monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Epitel, Inc. on 2024-08-27.