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

NCT05241678 | Completed DMC

• 1 other identifier: 20-011
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy, Generalized

Outcome Measures

Primary Outcomes (1)

• Electrographic seizure recording sensitivity of the 24/7 EEG™ SubQ system: proportion of identified seizures as compared to ipsilateral video-EEG recordings with the standard 10-20 electrode system.

  Electroclinical seizure count recorded on SubQ EEG compared to vEEG.

  12 weeks

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Beaumont Hospital neurology patients with refractory generalised genetic epilepsy. Consenting adults between the ages of 18/75 yrs, with full capacity

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• UNEEG Medical A/S: collaborator
• Science Foundation Ireland: collaborator

Study Sites (1)

RCSI

Dublin, Ireland

Location

MeSH Terms

Conditions

Epilepsy, Generalized

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Norman Delanty, MD

  Royal College of Surgeons, Dublin, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: February 16, 2022
• Study Start: February 15, 2022
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)