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

NCT04526418 | Terminated DMC FDA Device

• 1 other identifier: U002
• Study Type: interventional
• Target: 64
• Locations: 3 countries
• Sites: 12

Brief Summary

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

Conditions

Epilepsy

Keywords

Ultra Long-Term Recording of Patients with Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• adverse event

  2 years

Study Arms (1)

24/7 EEG™ SubQ System

EXPERIMENTAL

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

Interventions

24/7 EEG™ SubQ system DEVICE

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

24/7 EEG™ SubQ System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18-75 years old.
• Semiology of seizures compatible with temporal lobe involvement.
• 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).
• 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.

You may not qualify if:

• 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:
• antiplatelets
• anticoagulants
• chemotherapeutics
• 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 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).
• Subject is pregnant
• Subject has contraindicated profession or hobby
• Subject is scheduled to undergo contraindicated treatments/investigations
• Infection at the implant site
• Subject has contraindication to the use of anesthetic used for in/ex plantation.
• Subject is unable to use/operate the device system
• Subject has abnormal Laboratory findings as follows:

Sponsors & Collaborators

• UNEEG Medical A/S: lead

Study Sites (12)

University of California

Los Angeles, California, 90095, United States

Location

University of South Florida (USF) Neurology Department

Tampa, Florida, 33606, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hackensack Meridian Health

Neptune City, New Jersey, 07753, United States

Location

Northwell Health Department of Neurosurgery

Great Neck, New York, 11021, United States

Location

Cleveland Clinic, Neurological Institute

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvenia

Philadelphia, Pennsylvania, 19104, United States

Location

UT Health Houston

Houston, Texas, 77030, United States

Location

Hopital Erasme - Universite Libre de Bruxelles

Brussels, 1070, Belgium

Location

Krankenhaus Mara, Gesellschaft für Epilepsieforschung e.V.

Bielefeld, 33617, Germany

Location

Universität Klinikum Freibrug

Freiburg im Breisgau, 79106, Germany

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Michael Gelfand

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label, prospective study with a paired comparative design for pivotal evaluation of the safety and effectiveness of the 24/7 EEC SubQ system in subjects with epilepsy involving the temporal lobe region.

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 25, 2020
• Study Start: April 21, 2021
• Primary Completion: July 22, 2025
• Study Completion: August 29, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); BE (1); US (9)