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Epitel's™ REMI™ System for Seizure Monitoring

This study is testing Epitel's™ Remote EEG Monitoring System (REMI™), a portable device that records brain activity (EEG) to detect seizures. The goal is to see if this system can capture more seizure events over 14 days compared to 3 days, and if doctors find this longer monitoring helpful for diagnosing and treating seizures. You might be able to join if you are between 18 and 70 years old, have a history of seizures, and typically experience at least one seizure every two weeks. The study aims to enroll 65 participants, but its current status is unclear.

Study design
This is an interventional study that plans to enroll 65 participants. It is a prospective study, meaning participants will be followed forward in time.
What's involved
You would wear the REMI™ device for 14 to 28 days in your home or community setting.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 14 days.

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NCT06027749

Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System.

Recruiting
NAAges 18–70InterventionalDiagnostic
Epitel, Inc.
~65 participants
Updated 2024-08-27 on ClinicalTrials.gov
What's tested:Epitel's™ Remote EEG Monitoring System's (REMI™)

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ictal Events Identified in fourteen (14) days.
Measured over Fourteen (14) days

Conditions

Epilepsy
Seizures

Explore related trials

SeizureSeizure Disorder

Where it's being run

2 sites across 2 states
Florida1
South Carolina1

Who to contact

Marina Azevedo, BSc
[email protected]
813-250-2323
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Ictal Events Identified in fourteen (14) days.Fourteen (14) days

    Epileptiform seizure activity as identified by three independent board-certified epileptologists assessing data collected by REMI. The number of seizures identified in the first three days will be compared to the number of seizures identified during days one (1) to fourteen (14).