Wireless long-term EEG monitoring for epilepsy patients
Wireless Ultra Long-Term EEG Recordings in Epilepsy - a Prospective Long-term Clinical Evaluation Using the UNEEG EpiSight Solution
NA · UNEEG Medical A/S · NCT05915988
This study is testing a new wireless device for continuous brain monitoring to see if it helps people with uncontrolled epilepsy feel safer and more satisfied with their treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 19 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNEEG Medical A/S (industry) |
| Locations | 5 sites (Aalborg and 4 other locations) |
| Trial ID | NCT05915988 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and performance of the UNEEG EpiSight solution for continuous EEG monitoring in patients with uncontrolled epilepsy. It is an open-label, prospective, multi-center study conducted across 2-5 sites in Europe, aiming to enroll up to 22 subjects. Participants will undergo a surgical procedure for device implantation and will be monitored for 40 days to assess device effectiveness and patient satisfaction. The study will last approximately 22 months from the first visit to the last subject's exit.
Who should consider this trial
Good fit: Ideal candidates are adults with uncontrolled epilepsy where seizures can be detected in the area covered by the implant.
Not a fit: Patients with severe cognitive impairment or those at high risk for surgical complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a reliable method for continuous seizure monitoring, improving management of epilepsy.
How similar studies have performed: While similar approaches have been explored, this specific device and methodology are relatively novel in the context of long-term EEG monitoring.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with uncontrolled epilepsy in which seizures are detectable in an area covered by the implant * Adults (above 18 years) * Is willing and able to use the UNEEG EpiSight solution day and night for the duration of the study * Subject is willing and able to provide written informed consent * Subject is able to complete all study-required procedures, assessments and follow-up Exclusion Criteria: * Vulnerable subjects, including severe cognitive impairment precluding informed consent * Cannot or do not have the necessary assistance, to properly operate the system * High risk of surgical complications, such as active systemic infection and haemorrhagic disease * Involved in therapies with medical devices that deliver electrical energy into the area around the implant, such as cochlear implant(s), implantable brain stimulation and external/transcranial brain stimulation * Contraindications to the local anaesthetic used during implantation and explantation
Where this trial is running
Aalborg and 4 other locations
- Aalborg University Hospital — Aalborg, Denmark (RECRUITING)
- Odense University Hospital — Odense, Denmark (RECRUITING)
- Regional Hospital of Viborg — Viborg, Denmark (RECRUITING)
- Cork University Hospital — Cork, Ireland (RECRUITING)
- Beaumont Hospital — Dublin, Ireland (RECRUITING)
Study contacts
- Principal investigator: Norman Delanty, Prof — Beaumont Hospital, Dublin
- Study coordinator: Charlotte E Torngaard
- Email: studies@uneeg.com
- Phone: 004540586959
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.
Conditions: Epilepsy