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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Epilepsy
Intervention / Treatment

-

Contacts and Locations

Tampa

University of South Florida, Tampa, Florida, United States, 33606

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29407

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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).

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Epitel, Inc.,

Study Record Dates

2025-06-01