Actively Recruiting
Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System.
Led by Epitel, Inc. · Updated on 2024-08-27
65
Participants Needed
2
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
- Cannot read, speak, or understand English (and does not have a translator)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29407
Enrolling by Invitation
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
0
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