Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System.
Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With REMI.
Epitel, Inc.
65 participants
Oct 13, 2023
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria7
- 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 Criteria4
- 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).
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Interventions
Ambulatory electroencephalography (EEG) monitoring
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06027749