Clinical trial NCT05915988: U011 - Wireless Ultra Long-Term EEG Recordings in Epilepsy
Official title: Wireless Ultra Long-Term EEG Recordings in Epilepsy - a Prospective Long-term Clinical Evaluation Using the UNEEG EpiSight Solution
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Lead sponsor: UNEEG Medical A/S
Sponsor class: INDUSTRY
First posted: 2023-06-23
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study is a 13 months pre-market open-label, prospective study for confirmation of continuous performance and safety of UNEEG EpiSight solution in subjects with uncontrolled epilepsy (indicated for EEG monitoring with the Implant) in which seizures are detectable in an area of the Implant. The surgical procedure, device satisfaction, and effectiveness of the UNEEG EpiSight solution will also be evaluated during the clinical investigation.

Detailed description: The study is a multi-center study with 2-5 European sites in 2-4 countries. Each site will enrol up to 10 subjects, but total enrolment will not exceed 22 to reach 19 completers of 40 days of recording. The total recruitment period is expected to be 6 months and the total study duration is expected to be approximate 22 months (first subject first visit to last subject out).

Eligibility 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

Primary outcomes:
measure: Usage of UNEEG EpiSight Recorder
timeFrame: Throughout the run of the investigation (enrollment per subject is up to 12 months)
Secondary outcomes:
measure: Device deficiencies
timeFrame: Throughout the run of the investigation (enrollment per subject is up to 12 months)
measure: Adverse events
timeFrame: Throughout the run of the investigation (enrollment per subject is up to 12 months)
Other outcomes:
measure: Performance
timeFrame: Throughout the run of the investigation (enrollment per subject is up to 12 months)
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Viborg
country: Denmark
facility: Regional Hospital of Viborg
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: Beaumont Hospital, Dublin
name: Norman Delanty, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Cork University Hospital
name: Daniel Costello, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Christoph Beier, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional Hospital of Viborg
name: Lis Gregoretti Pluss, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University Hospital
name: Kimmo Jensen, Prof
role: PRINCIPAL_INVESTIGATOR
References: