Impact of Capturing Ictal Events With Ultra-long-term Amb... | NCT06027749

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

NCT06027749

Sponsor

Epitel, Inc.

Status

Recruiting

Last Update Posted

Aug 27, 2024Actual

Enrollment

65Estimated

Phase

Not Applicable

Conditions

Epilepsy
Seizures

Interventions

Epitel's™ Remote EEG Monitoring System's (REMI™)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 13, 2023Actual

Primary Completion Date

Mar 30, 2025Estimated

Completion Date

Jun 1, 2025Estimated

First Submitted Date

Aug 31, 2023

First Submission Date that Met QC Criteria

Aug 31, 2023

First Posted Date

Sep 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2024

Last Update Posted Date

Aug 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Epitel's™ Remote EEG Monitoring System's (REMI™)	Device	Ambulatory electroencephalography (EEG) monitoring

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	Fourteen (14) days

Secondary Outcomes

Measure	Description	Time Frame
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.	Twenty-eight (28) days

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of South Florida	Recruiting	Tampa	Florida	33606	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

No IPD will be shared with other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy
D012640	Seizures

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided