Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System.
Recruiting now · Not applicable
Conditions studied: Epilepsy, Seizures
In brief
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.
Key facts
- Study ID
- NCT06027749
- Run by
- Epitel, Inc.
- People needed
- 65
- Starts
- 2023-10-13
- Expected to finish
- 2025-06-01
- Last updated by the study team
- 2024-08-27
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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
- University of South Florida — Tampa, Florida, United States (enrolling)
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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