Clinical trial NCT06027749: Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System.
Official title: Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With REMI.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Seizures
Keywords: EEG Monitoring
Lead sponsor: Epitel, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-07
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Cohort
Primary purpose: DIAGNOSTIC

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.

Detailed description: This is a prospective study to quantify 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). Patients presenting with questionable seizure characterization that are scheduling a conventional at home ambulatory EEG (Amb EEG) and who meet the study inclusion and exclusion criteria will be prescribed a REMI system.

The purpose of this study is to demonstrate that the REMI system is able to record EEG data that clinicians can use to identify ictal events over extended periods, and that extended clinical EEG data is valuable in the diagnosis and treatment of seizure related symptoms.

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).

Primary outcomes:
measure: Ictal Events Identified in fourteen (14) days.
timeFrame: Fourteen (14) days
Secondary outcomes:
measure: Extended Use
timeFrame: Twenty-eight (28) days
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: