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

Not Applicable

Recruiting

• Conditions: Epilepsy
• Interventions: Device: 24/7 EEG™ SubQ system

• Registration Number: NCT04526418
• Lead Sponsor: UNEEG Medical A/S

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-25
• Study Start: 2021-04-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-09-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
24/7 EEG™ SubQ System	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.

Primary Outcome Measures

Name	Time	Method
number of seizures	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).

Secondary Outcome Measures

Name	Time	Method
adverse event	2 years	safety reporting

Trial Locations

Locations (13)

UT Health Houston; 🇺🇸 Houston, Texas, United States

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, 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

Hopital Erasme - Universite Libre de Bruxelles; 🇧🇪 Brussels, Belgium

Krankenhaus Mara, Gesellschaft für Epilepsieforschung e.V.; 🇩🇪 Bielefeld, Germany

Universität Klinikum Freibrug; 🇩🇪 Freiburg, Germany

Walton Centre NHS Foundation Trust; 🇬🇧 Fazakerley, Liverpool, United Kingdom