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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04526418
• Other study ID #: U002
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: November 2023
• Source: UNEEG Medical A/S
• Contact: Pia Nordmand
• Phone: +45 20709801
• Email: pnor[@]uneeg.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 temporal lobe epilepsy.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Temporal Lobe

Intervention

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

Locations

Country	Name	City	State
Germany	Universität Klinikum Freibrug	Freiburg
United Kingdom	Walton Centre NHS Foundation Trust	Fazakerley	Liverpool
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of California	Los Angeles	California
United States	University of Pennsylvenia	Philadelphia	Pennsylvania
United States	Mayo Clinic	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
UNEEG Medical A/S

Countries where clinical trial is conducted

United States,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	adverse event	safety reporting	2 years