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

Stopped early · Not applicable

Conditions studied: Epilepsy

In brief

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

Key facts

Study ID: NCT04526418
Run by: UNEEG Medical A/S
People needed: 64
Starts: 2021-04-21
Expected to finish: 2025-08-29
Last updated by the study team: 2025-09-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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:
Serum creatinine ≥ 3 times upper reference value
Alanine aminotransferase (ALT), alkaline phosphatase or bilirubin ≥ 3 times upper reference value
Activated Partial Thromboplastin Time (APTT) \&gt; 50 seconds
thrombocyte count \&lt; 50 or \&gt;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.

Where it is running

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

Full record on ClinicalTrials.gov

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