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

Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region. 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 epilepsy involving the temporal lobe region .

2-5 sites in Europe Up to 10 sites in US

Study Overview

• Status: Terminated
• Conditions: Epilepsy
• Intervention / Treatment: Device: 24/7 EEG™ SubQ system

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Hopital Erasme - Universite Libre de Bruxelles
• Germany
  • Bielefeld, Germany, 33617
    • Krankenhaus Mara, Gesellschaft für Epilepsieforschung e.V.
  • Freiburg im Breisgau, Germany, 79106
    • Universität Klinikum Freibrug
• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California
  • Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida (USF) Neurology Department
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New Jersey
    • Neptune City, New Jersey, United States, 07753
      • Hackensack Meridian Health
  • New York
    • Great Neck, New York, United States, 11021
      • Northwell Health Department of Neurosurgery
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic, Neurological Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvenia
  • Texas
    • Houston, Texas, United States, 77030
      • UT Health Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

INCLUSION CRITERIA

1. Subject is 18-75 years old.
2. Semiology of seizures compatible with temporal lobe involvement.
3. Paraclinical findings supporting temporal seizure involvement. 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).
4. Uncontrolled epileptic seizures.
5. Subject has planned clinical EMU admission with an admission goal including capturing epileptic seizures, within 12 weeks after the date of UNEEG™ SubQ implant.
6. Subject is willing and able to provide written informed consent.
7. Subject is able to complete all study-required procedures, assessments and follow-up.

EXCLUSION CRITERIA

1. 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.

2. 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)
3. Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement.
4. Subject is involved in therapies with other active implantable devices that deliver electrical energy above the clavicular area, such as implantable brain stimulation, external/transcranial brain stimulation, vagus nerve stimulator (VNS) and cochlear implant(s).
5. Subject is pregnant
6. Subject has contraindicated profession or hobby
7. Subject is scheduled to undergo contraindicated treatments/investigations
8. Infection at the implant site
9. Subject has contraindication to the use of anesthetic used for in/ex plantation.
10. Subject is unable to use/operate the device system

11. Subject has abnormal Laboratory findings as follows:

    • Serum creatinine ≥ 3 times upper reference value
    • Alanine aminotransferase (ALT), alkaline phosphatase or bilirubin ≥ 3 times upper reference value
    • Activated Partial Thromboplastin Time (APTT) > 50 seconds
    • thrombocyte count < 50 or >1000 x 109/L
    • International Normalised Ratio (INR) ≥ 1.6
    • Any other clinical or paraclinical finding that in the opinion of the Investigator would interfere with participation in the study or would confound interpretation of the study results.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

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	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	safety reporting	2 years

Collaborators and Investigators

• Sponsor: UNEEG Medical A/S
• Investigators: Principal Investigator: Michael Gelfand, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Actual): July 22, 2025
• Study Completion (Actual): August 29, 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 (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Ultra Long-Term Recording of Patients with Epilepsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• 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