NCT06027749 Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System.
| NCT ID | NCT06027749 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Epitel, Inc. |
| Condition | Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2023-10-13 |
| Primary Completion | 2025-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 65 participants in total. It began in 2023-10-13 with a primary completion date of 2025-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Frequently Asked Questions
Who can join the NCT06027749 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06027749 currently recruiting?
Yes, NCT06027749 is actively recruiting participants. Visit ClinicalTrials.gov or contact Epitel, Inc. to inquire about joining.
Where is the NCT06027749 trial being conducted?
This trial is being conducted at Tampa, United States, Charleston, United States.
Who is sponsoring the NCT06027749 clinical trial?
NCT06027749 is sponsored by Epitel, Inc.. The trial plans to enroll 65 participants.
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