Status:
COMPLETED
Evaluation of the 24/7 EEG™ SubQ System in Subjects With Uncontrolled Genetic Generalised Epilepsy Syndrome
Lead Sponsor:
Royal College of Surgeons, Ireland
Collaborating Sponsors:
UNEEG Medical A/S
Science Foundation Ireland
Conditions:
Epilepsy, Generalized
Eligibility:
All Genders
18-75 years
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 purpo...
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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.
- Previous surgery not an exclusion criteria Subjects scheduled for the following treatments within 4 weeks of enrolment: MRI, radiotherapy, U/S close to implant site, ECT, electro knife procedures.
- Subject unable or does not have the assistance to operate the device properly.
- \-
Key Trial Info
Start Date :
February 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 29 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05241678
Start Date
February 15 2022
End Date
December 29 2023
Last Update
March 7 2024
Active Locations (1)
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1
RCSI
Dublin, Ireland