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

NCT ID: NCT05241678

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2023-12-29

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Diagnosis of refractory genetic generalised epilepsy. Refractory: failure of 2 or more AEDs at appropriate dose.

Seizure frequency of at least one per month over the past 18 months. Subject willing and able to give written informed consent. Subject or guardian has ability to operate system. Subject is able and willing to complete all investigations, required procedures, assessments and follow up.

Subject will tolerate a planned EMU admission within 4 weeks of insertion of device.

Exclusion Criteria

Subjects who lack capacity to give fully informed consent. Candidates must be at no risk of surgical complications - on no more than 2 days per week of chemotherapy, blood thinning agents, or NSAID.

Device is non-MRI compatible; subjects should not be scheduled for MRI after enrolment, operate or be near an MRI scanner.

Contraindication to use of local anaesthetic drugs during implant and explant surgery.

Pregnancy. Activities that might infer additional risk at participation or affect quality of data. Subject has a hobby or job that delivers extreme pressure variations, ie, diving (5metres acceptable), or that imposes risk or trauma for the device, ie boxing.

Skeletal deformity at insertion site, impeding correct electrode placement. Existing infection at insertion site Participant has or is exposed to a medical device that delivers electrical current near the area of implant - DBS, cochlear implant. VNS is not excluded.

Subject unable or does not have the assistance to operate the device properly.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UNEEG Medical A/S

INDUSTRY

Sponsor Role: collaborator

Science Foundation Ireland

OTHER

Sponsor Role: collaborator

Royal College of Surgeons, Ireland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Norman Delanty, MD

Role: PRINCIPAL_INVESTIGATOR

Royal College of Surgeons, Dublin, Ireland

Locations

RCSI

Dublin, , Ireland

Countries

Ireland

Other Identifiers

20-011

Identifier Type: -

Identifier Source: org_study_id