Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System.
Recruiting · NCT06027749 · Interventional (participants receive a specific treatment) · Lead sponsor: Epitel, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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).
Where it is running
2 locations listed across 2 US states.
- University of South Florida - Tampa, Florida, United States
- Medical University of South Carolina - Charleston, South Carolina, United States