NCT05241678Completed
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
Source: ClinicalTrials.gov · Last updated 7 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 13 (actual)
- First submitted
- 22 Nov 2021
- Start date
- 15 Feb 2022
- Primary completion date
- 29 Dec 2023
- Lead sponsor
- Royal College of Surgeons, Ireland
- Diseases
- Epilepsy
- NCT number
- NCT05241678
What you commit to
- Study type: Observational
- Participants enrolled: 13
- From 15 Feb 2022 to the primary completion date, 29 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Contraindication to use of local anaesthetic drugs during implant and explant surgery.
- 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.
Other illness
- 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.
Other
- Device is non-MRI compatible; subjects should not be scheduled for MRI after enrolment, operate or be near an MRI scanner.
- 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.
- Subject unable or does not have the assistance to operate the device properly.
- \-
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RCSI Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.