Status:
RECRUITING
Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System.
Lead Sponsor:
Epitel, Inc.
Conditions:
Epilepsy
Seizures
Eligibility:
All Genders
18-70 years
Phase:
NA
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 perio...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT06027749
Start Date
October 13 2023
End Date
June 1 2025
Last Update
August 27 2024
Active Locations (2)
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1
University of South Florida
Tampa, Florida, United States, 33606
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29407