Using a portable EEG device to monitor seizures over extended periods.
Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With REMI.
NA · Epitel, Inc. · NCT06027749
This study is testing a portable device that tracks brain activity to see if it can help people with unclear seizure types by monitoring them for up to 28 days at home.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Epitel, Inc. (industry) |
| Locations | 2 sites (Tampa, Florida and 1 other locations) |
| Trial ID | NCT06027749 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Epitel's Remote EEG Monitoring System (REMI) in capturing seizure events through electroencephalography (EEG) over a prolonged period of 14 to 28 days in patients with uncertain seizure characterization. Participants will wear the REMI device in their home or community settings, allowing for continuous monitoring. The study aims to determine if longer monitoring periods yield more recorded seizure events compared to traditional shorter monitoring and whether this extended data is valuable for clinicians in diagnosing and treating seizure-related conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 with a history of seizures and a minimum seizure frequency of one every two weeks.
Not a fit: Patients who are homeless, lack a power supply, or have severe allergies to the materials used in the EEG device may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of seizure diagnosis and improve treatment strategies for patients with epilepsy.
How similar studies have performed: Other studies have shown promise in using extended EEG monitoring for seizure detection, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tampa, Florida and 1 other locations
- University of South Florida — Tampa, Florida, United States (RECRUITING)
- Medical University of South Carolina — Charleston, South Carolina, United States (ENROLLING_BY_INVITATION)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epilepsy, Seizures, EEG Monitoring