RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-10-13
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06027749

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients have a reported history of seizures (epileptic, non-epileptic, or unknown),
  2. * Have a minimum reported seizure rate of one every two weeks,
  3. * Are prescribed an ambulatory EEG study as part of routine care,
  4. * Is Male or Female between the ages of 18 and 70,
  5. * Can understand and sign written informed consent, or have a legal guardian provide consent,
  6. * The Patient (or Primary Caregiver) must be competent to follow all study procedures,
  7. * The Patient must be willing to use the System for a prolonged period (up to 30 days), for a minimum of 20 hours/day.
  1. * Is sensitive or allergic to medical acrylics, silicones, or hydrogels,
  2. * Is enrolled in another investigational drug or device trial,
  3. * Is homeless or in a home without a power supply, or
  4. * Cannot read, speak, or understand English (and does not have a translator).

Contacts and Locations

Study Locations (Sites)

University of South Florida
Tampa, Florida, 33606
United States
Medical University of South Carolina
Charleston, South Carolina, 29407
United States

Collaborators and Investigators

Sponsor: Epitel, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-13
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2023-10-13
Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

  • EEG Monitoring

Additional Relevant MeSH Terms

  • Epilepsy
  • Seizures