Wireless Ultra Long-Term EEG Recordings in Epilepsy (WULTER)

Wireless Ultra Long-Term EEG Recordings in Epilepsy - A Prospective Long-term Clinical Evaluation Using the UNEEG EpiSight Solution

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Device: UNEEG EpiSight solution

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).

• Study Type: Interventional
• Enrollment (Estimated): 19
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rikke Boege, BCs; Phone Number: +45 2712 9303; Email: studies@uneeg.com

Study Locations

• Denmark
  • Fyn
    • Odense, Fyn, Denmark, 5000
      • Recruiting
      • Odense University Hospital
      • Contact: Christoph Beier, Prof
      • Contact: Study Coordinator; Phone Number: +45 6541 1943

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: open-label; UNEEG EpiSight solution	Device: UNEEG EpiSight solution; Implantation subcutis under local anesthetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usage of UNEEG EpiSight Recorder	Number of recording hours by UNEEG EpiSight Recorder per day (24 hours) after 40 days recording	Throughout the run of the investigation (enrollment per subject is up to 12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device deficiencies	Nature and frequency of device deficiencies	Throughout the run of the investigation (enrollment per subject is up to 12 months)
Adverse events	Nature and frequency of adverse events	Throughout the run of the investigation (enrollment per subject is up to 12 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance	Number of recording hours by UNEEG EpiSight solution per day (24 hours) throughout the study period	Throughout the run of the investigation (enrollment per subject is up to 12 months)

Collaborators and Investigators

• Sponsor: UNEEG Medical A/S
• Investigators: Principal Investigator: Norman Delanty, Prof, Beaumont Hospital, Dublin

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: UNEEG-U011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No