Back to resultsImpact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System. (REMI)
Primary Purpose
Epilepsy, Seizures
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epitel's™ Remote EEG Monitoring System's (REMI™)
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy focused on measuring EEG Monitoring
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).
Sites / Locations
- University of South FloridaRecruiting
- Medical University of South Carolina
Outcomes
Primary Outcome Measures
Ictal Events Identified in 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).
Secondary Outcome Measures
Extended Use
Epileptiform seizure activity as identified by three independent board-certified epileptologists assessing data collected by REMI. The number of seizures identified in the first fourteen (14) days will be compared to the number of seizures identified during all twenty-eight (28) days.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06027749
Brief Title
Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System.
Acronym
REMI
Official Title
Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With REMI.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epitel, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Seizures
Keywords
EEG Monitoring
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective Cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Epitel's™ Remote EEG Monitoring System's (REMI™)
Intervention Description
Ambulatory electroencephalography (EEG) monitoring
Primary Outcome Measure Information:
Title
Ictal Events Identified in fourteen (14) days.
Description
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).
Time Frame
Fourteen (14) days
Secondary Outcome Measure Information:
Title
Extended Use
Description
Epileptiform seizure activity as identified by three independent board-certified epileptologists assessing data collected by REMI. The number of seizures identified in the first fourteen (14) days will be compared to the number of seizures identified during all twenty-eight (28) days.
Time Frame
Twenty-eight (28) days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Azevedo, BSc
Phone
813-250-2323
Email
azevedom@usf.edu
First Name & Middle Initial & Last Name & Degree
Ana Omura, BSc
Phone
813-259-8524
Email
aomura@usf.edu
First Name & Middle Initial & Last Name & Degree
Salim Benbadis, MD
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Individual Site Status
Enrolling by invitation
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared with other researchers.
Learn more about this trial
Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System.
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