Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Temporal Lobe Epilepsy

November 20, 2023 updated by: UNEEG Medical A/S

Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Temporal Lobe Epilepsy An Open-label, Prospective, Paired, Comparative Study

The 24/7 EEG™ SubQ system will be compared to simultaneously recorded video-EEG in the Epilepsy Monitoring Unit (gold standard) and to self-reported seizure log books throughout 12 weeks of outpatient EEG recording.

The present study is a 12-week open-label, prospective study with a paired, comparative design for pivotal evaluation of the safety and effectiveness of the 24/7 EEGTM SubQ system in subjects with temporal lobe epilepsy.

2-5 sites in Europe Up to 5 sites in US, or up to 10 sites if approval granted.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
  • United Kingdom
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
    • California
      • Los Angeles, California, United States, 90095
        • Not yet recruiting
        • University of California
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvenia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject is 18-75 years old.
  • Semiology of seizures compatible with temporal lobe involvement
  • Paraclinical findings supporting temporal seizure focus. Such proof may consist of: - previous EEG recording interpreted as compatible with temporal involvement OR - radiological findings demonstrating pathology in the temporal area (CT, MRI, FDG-PET or SPECT).
  • Uncontrolled epileptic seizures.
  • Subject has planned clinical EMU admission with an admission goal including capturing epileptic seizures, within 12 weeks after the date of UNEEG™ SubQ implant.
  • Subject is willing and able to provide written informed consent.
  • Subject is able to complete all study-required procedures, assessments and follow-up.

Exclusion Criteria:

  • Subject has a condition that places him/her at a high at high risk of surgical complications, such as an active systemic infection or a hemorrhagic disease.

  • Subject receives frequent (more than 2 days per week) treatment with drugs of the following types:

    1. antiplatelets
    2. anticoagulants
    3. chemotherapeutics
    4. non-steroid anti-inflammatory drugs (NSAID)
  • Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement.
  • Subject has an active deep brain stimulation device.
  • Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant.
  • Subject has a cochlear implant(s).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 24/7 EEG™ SubQ System
To demonstrate the electrographic seizure recording effectiveness of the 24/7 EEG™ SubQ system by comparison to simultaneous inpatient video-EEG data.
Device: 24/7 EEG™ SubQ system
Electrographic seizure recording sensitivity of an ipsilaterally implanted 24/7 EEG™ SubQ system: proportion of identified ipsilateral seizures as compared to ipsilateral video-EEG during admission to the Epilepsy Monitoring Unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of seizures
Time Frame: comparasion in EMU for 3-14 days period, where patients are hospitalized.
numbers of seizures as detected in EEG data from SubQ to be compared with number of seizures detected in golden standard (video EEG).
comparasion in EMU for 3-14 days period, where patients are hospitalized.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse event
Time Frame: 2 years
safety reporting
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNEEG Medical A/S

Investigators

  • Principal Investigator: Michael Gelfand, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2021

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 24, 2020

First Posted (Actual)

August 25, 2020

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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