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Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Temporal Lobe Epilepsy

Primary Purpose

Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
24/7 EEG™ SubQ system
Sponsored by
UNEEG Medical A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is 18-75 years old.
  • Semiology of seizures compatible with temporal lobe involvement
  • Paraclinical findings supporting temporal seizure focus. 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.
  • 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:

    1. antiplatelets
    2. anticoagulants
    3. chemotherapeutics
    4. 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 has an active deep brain stimulation device.
  • Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant.
  • Subject has a cochlear implant(s).

Sites / Locations

  • Mayo ClinicRecruiting
  • University of PennsylveniaRecruiting
  • Universität Klinikum FreibrugRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

24/7 EEG™ SubQ System

Arm Description

To demonstrate the electrographic seizure recording effectiveness of the 24/7 EEG™ SubQ system by comparison to simultaneous inpatient video-EEG data.

Outcomes

Primary Outcome Measures

number of seizures
numbers of seizures as detected in EEG data from SubQ to be compared with number of seizures detected in golden standard (video EEG).

Secondary Outcome Measures

adverse event
safety reporting

Full Information

First Posted
August 10, 2020
Last Updated
August 24, 2023
Sponsor
UNEEG Medical A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04526418
Brief Title
Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Temporal Lobe Epilepsy
Official Title
Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Temporal Lobe Epilepsy An Open-label, Prospective, Paired, Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNEEG Medical A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 temporal lobe epilepsy. 2-5 sites in Europe Up to 5 sites in US, or up to 10 sites if approval granted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
open-label, prospective study with a paired comparative design for pivotal evaluation of the satety and effectiveness of the 24/7 EEC SubQ system in subjects with temporal lobe epilepsy.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
24/7 EEG™ SubQ System
Arm Type
Experimental
Arm Description
To demonstrate the electrographic seizure recording effectiveness of the 24/7 EEG™ SubQ system by comparison to simultaneous inpatient video-EEG data.
Intervention Type
Device
Intervention Name(s)
24/7 EEG™ SubQ system
Intervention Description
Electrographic seizure recording sensitivity of an ipsilaterally implanted 24/7 EEG™ SubQ system: proportion of identified ipsilateral seizures as compared to ipsilateral video-EEG during admission to the Epilepsy Monitoring Unit
Primary Outcome Measure Information:
Title
number of seizures
Description
numbers of seizures as detected in EEG data from SubQ to be compared with number of seizures detected in golden standard (video EEG).
Time Frame
comparasion in EMU for 3-14 days period, where patients are hospitalized.
Secondary Outcome Measure Information:
Title
adverse event
Description
safety reporting
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is 18-75 years old. Semiology of seizures compatible with temporal lobe involvement Paraclinical findings supporting temporal seizure focus. 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. 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 has an active deep brain stimulation device. Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant. Subject has a cochlear implant(s).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lykke Blaabjerg
Phone
+45 41414244
Email
lybl@uneeg.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Pathmanathan
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Worrell
Facility Name
University of Pennsylvenia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Gelfand
Phone
215-662-3606
Email
psom-ocr@pobox.upenn.edu
Facility Name
Universität Klinikum Freibrug
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Schulze-Bonhage
Phone
+49 761 270 53660
Email
andreas.schulze-bonhage@uniklinik-freiburg.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Temporal Lobe Epilepsy

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