Epilepsy, GeneralizedNCT05241678
Evaluation of the 24/7 EEG™ SubQ System in Subjects With Uncontrolled Genetic Generalised Epilepsy Syndrome
An observational study of Epilepsy, Generalized, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Generalized
- How many people
- 13 participants
- Where
- 1 siteIreland
- Study dates
- 15 Feb 2022to 29 Dec 2023
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Beaumont Hospital neurology patients with refractory generalised genetic epilepsy. Consenting adults between the ages of 18/75 yrs, with full capacity
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Title: Evaluation of the 24/7 EEG™ SubQ System in Subjects With Uncontrolled Genetic Generalised Epilepsy Syndrome
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.
Read the 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
- Medical subject headings
- Epilepsy, Generalized
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start15 Feb 2022
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, GeneralizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- UNEEG Medical A/S, Science Foundation Ireland
- Responsible party
- Sponsor
- Investigators
- Norman Delanty, MD, Principal investigator, Royal College of Surgeons, Dublin, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241678
- Sponsor's protocol ID
- 20-011
- Status last verified
- Mar 2024
- First submitted
- 22 Nov 2021
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Title: Evaluation of the 24/7 EEG™ SubQ System in Subjects With Uncontrolled Genetic Generalised Epilepsy Syndrome
- ClinicalTrials.gov ID
- NCT05241678
- Acronym / sponsor ID
- 20-011
- Conditions
- Epilepsy, Generalized
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- UNEEG Medical A/S, Science Foundation Ireland
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Beaumont Hospital neurology patients with refractory generalised genetic epilepsy. Consenting adults between the ages of 18/75 yrs, with full capacity
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 12 weeks
Electroclinical seizure count recorded on SubQ EEG compared to vEEG.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman Delanty, MD principal investigator
Royal College of Surgeons, Dublin, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, Generalized, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.