NCT05241678

Evaluation of the 24/7 EEG™ SubQ System in Subjects With Uncontrolled Genetic Generalised Epilepsy Syndrome

Study Title: Evaluation of the 24/7 EEG™ SubQ System in Subjects With Uncontrolled Genetic Generalised Epilepsy Syndrome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Royal College of Surgeons, Ireland · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is a 12 week prospective, comparative investigation in subjects diagnosed with uncontrolled genetic generalised epilepsy (GGE) also known as idiopathic generalised epilepsy (IGE). The purpose of the study is to evaluate whether the 24/7 EEG™ SubQ system, a subcutaneous implantable device, will demonstrate seizure sensitivity approximating that of inpatient video-EEG monitoring with the standard 10-20 electrode system.

Detailed description

The purpose of this study is to evaluate the performance of the '24/7 EEG SubQ system' monitoring device in uncontrolled generalised genetic epilepsy syndromes. It is hypothesised that this system will demonstrate seizure sensitivity comparable to Video EEG monitoring with a standard 10-20 electrode system, which is done in a hospital setting and is considered the gold standard for a diagnosis/evaluation of epilepsy. Ten patients will be recruited with uncontrolled genetic generalised epilepsy. All adults between ages 18-75 years with the ability to give full informed consent. This is an subcutaneously implanted ambulatory device; we will record EEG over a period of twelve weeks. The device consists of two parts: an implant - UNEEG - and an external storage unit (ELG) x 2 that also powers up the implant wirelessly through an inductive link. When the two parts are aligned on opposite sides of the skin: an external pad sits over the implanted device and EEG is recorded from the implanted contacts. The device is inserted under local anaesthetic by a neurosurgeon subcutaneously overlying the temporal region. Seizures will be recorded for 12 weeks, then the device will be removed. During the recording period, the patient will undertake video EEG monitoring with the aim of diagnosing seizures by video EEG (gold standard for diagnosis) and comparing the video EEG data with the UNEEG-recorded data. Throughout the recording period the patients will be overseen by their neurology team.

Conditions

• Epilepsy, Generalized

Timeline

• Start date: 2022-02-15
• Primary completion: 2023-12-29
• Completion: 2023-12-29
• First posted: 2022-02-16
• Last updated: 2024-03-07

Locations

1 site across 1 country: Ireland