An observational study in Epilepsy, Generalized, sponsored by Royal College of Surgeons, Ireland. Completed at 1 site in Ireland. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Royal College of Surgeons, Ireland · Observational
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.
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.
39 studies on the registry are indexed under Epilepsy, Generalized; 4 are open to participants now.
This study's enrollment of 13 is below the median of 80 across 13 observational studies indexed under Epilepsy, Generalized.
Browse Epilepsy, Generalized studies →Royal College of Surgeons, Ireland is the lead sponsor of 93 studies on the registry; 44 are open to participants now.
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Beaumont Hospital neurology patients with refractory generalised genetic epilepsy. Consenting adults between the ages of 18/75 yrs, with full capacity
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of 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 . 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 . 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.
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.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Royal College of Surgeons, Ireland