Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy In… (NCT04526418) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region.
Stopped: Futility analysis reached
United States, Belgium, Germany64 participantsStarted 2021-04-21
Plain-language summary
The 24/7 EEG™ SubQ system will be compared to simultaneously recorded video-EEG in the Epilepsy Monitoring Unit (gold standard) and to self-reported seizure log books throughout 12 weeks of outpatient EEG recording.
The present study is a 12-week open-label, prospective study with a paired, comparative design for pivotal evaluation of the safety and effectiveness of the 24/7 EEGTM SubQ system in subjects with epilepsy involving the temporal lobe region .
2-5 sites in Europe Up to 10 sites in US
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is 18-75 years old.
. Semiology of seizures compatible with temporal lobe involvement.
. Paraclinical findings supporting temporal seizure involvement. Such proof may consist of: - previous EEG recording interpreted as compatible with temporal involvement OR - radiological findings demonstrating pathology in the temporal area (CT, MRI, FDG-PET or SPECT).
. Uncontrolled epileptic seizures.
. Subject has planned clinical EMU admission with an admission goal including capturing epileptic seizures, within 12 weeks after the date of UNEEG™ SubQ implant.
. Subject is willing and able to provide written informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
number of seizures
Timeframe: comparasion in EMU for 3-14 days period, where patients are hospitalized.
. Subject is able to complete all study-required procedures, assessments and follow-up.
Exclusion criteria
. Subject has a condition that places him/her at a high at high risk of surgical complications, such as an active systemic infection or a hemorrhagic disease.
. Subject receives frequent (more than 2 days per week) treatment with drugs of the following types:
. antiplatelets
. anticoagulants
. chemotherapeutics
. non-steroid anti-inflammatory drugs (NSAID)
. Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement.
. Subject is involved in therapies with other active implantable devices that deliver electrical energy above the clavicular area, such as implantable brain stimulation, external/transcranial brain stimulation, vagus nerve stimulator (VNS) and cochlear implant(s).