Evaluation of a new EEG system for long-term monitoring of epilepsy patients
Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region. An Open-label, Prospective, Paired, Comparative Study.
This study is testing a new EEG system that continuously monitors people with temporal lobe epilepsy to see if it works better than the usual methods for tracking seizures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | UNEEG Medical A/S Industry-sponsored |
| Locations | 13 sites (Los Angeles, California and 12 other locations) |
| Trial ID | NCT04526418 on ClinicalTrials.gov |
What this trial studies
This study evaluates the 24/7 EEG™ SubQ system for ultra long-term monitoring of patients with temporal lobe epilepsy. It compares the performance of this system against the gold standard of video-EEG monitoring in an Epilepsy Monitoring Unit and self-reported seizure logs over a 12-week period. The study is open-label and prospective, involving multiple sites across Europe and the US, and aims to assess both the safety and effectiveness of the new EEG system.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with uncontrolled seizures and evidence of temporal lobe involvement.
Not a fit: Patients with conditions that pose a high risk for surgical complications or those receiving frequent treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and convenient method for monitoring epilepsy, potentially leading to better seizure management.
How similar studies have performed: Other studies have shown promise in using advanced EEG monitoring techniques, but the specific approach of the 24/7 EEG™ SubQ system is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA
1. Subject is 18-75 years old.
2. Semiology of seizures compatible with temporal lobe involvement.
3. 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).
4. Uncontrolled epileptic seizures.
5. Subject has planned clinical EMU admission with an admission goal including capturing epileptic seizures, within 12 weeks after the date of UNEEG™ SubQ implant.
6. Subject is willing and able to provide written informed consent.
7. Subject is able to complete all study-required procedures, assessments and follow-up.
EXCLUSION CRITERIA
1. 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.
2. Subject receives frequent (more than 2 days per week) treatment with drugs of the following types:
1. antiplatelets
2. anticoagulants
3. chemotherapeutics
4. non-steroid anti-inflammatory drugs (NSAID)
3. Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement.
4. 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).
5. Subject is pregnant
6. Subject has contraindicated profession or hobby
7. Subject is scheduled to undergo contraindicated treatments/investigations
8. Infection at the implant site
9. Subject has contraindication to the use of anesthetic used for in/ex plantation.
10. Subject is unable to use/operate the device system
11. Subject has abnormal Laboratory findings as follows:
* Serum creatinine ≥ 3 times upper reference value
* Alanine aminotransferase (ALT), alkaline phosphatase or bilirubin ≥ 3 times upper reference value
* Activated Partial Thromboplastin Time (APTT) \> 50 seconds
* thrombocyte count \< 50 or \>1000 x 109/L
* International Normalised Ratio (INR) ≥ 1.6
* Any other clinical or paraclinical finding that in the opinion of the Investigator would interfere with participation in the study or would confound interpretation of the study results.
Where this trial is running
Los Angeles, California and 12 other locations
- University of California — Los Angeles, California, United States (Active_not_recruiting)
- University of South Florida (USF) Neurology Department — Tampa, Florida, United States (Not_yet_recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Hackensack Meridian Health — Neptune, New Jersey, United States (Not_yet_recruiting)
- Northwell Health Department of Neurosurgery — Great Neck, New York, United States (Recruiting)
- Cleveland Clinic, Neurological Institute — Cleveland, Ohio, United States (Recruiting)
- University of Pennsylvenia — Philadelphia, Pennsylvania, United States (Recruiting)
- UT Health Houston — Houston, Texas, United States (Not_yet_recruiting)
- Hopital Erasme - Universite Libre de Bruxelles — Brussels, Belgium (Recruiting)
- Krankenhaus Mara, Gesellschaft für Epilepsieforschung e.V. — Bielefeld, Germany (Recruiting)
- Universität Klinikum Freibrug — Freiburg, Germany (Recruiting)
- Walton Centre NHS Foundation Trust — Fazakerley, Liverpool, United Kingdom (Withdrawn)
Study contacts
- Principal investigator: Michael Gelfand — University of Pennsylvania
- Study coordinator: Pia Nordmand, Director
- Email: pnor@uneeg.com
- Phone: +45 2070 9801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.