Clinical trial NCT04526418: Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Keywords: Ultra Long-Term Recording of Patients with Epilepsy
Lead sponsor: UNEEG Medical A/S
Sponsor class: INDUSTRY
First posted: 2020-08-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label, prospective study with a paired comparative design for pivotal evaluation of the safety and effectiveness of the 24/7 EEC SubQ system in subjects with epilepsy involving the temporal lobe region.
Primary purpose: DIAGNOSTIC

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 epilepsy involving the temporal lobe region .

2-5 sites in Europe Up to 10 sites in US


Eligibility 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) \&amp;gt; 50 seconds
    * thrombocyte count \&amp;lt; 50 or \&amp;gt;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.

Primary outcomes:
measure: number of seizures
timeFrame: comparasion in EMU for 3-14 days period, where patients are hospitalized.
Secondary outcomes:
measure: adverse event
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California
state: California
city: Tampa
country: United States
facility: University of South Florida (USF) Neurology Department
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Neptune
country: United States
facility: Hackensack Meridian Health
state: New Jersey
city: Great Neck
country: United States
facility: Northwell Health Department of Neurosurgery
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic, Neurological Institute
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvenia
state: Pennsylvania
city: Houston
country: United States
facility: UT Health Houston
state: Texas
city: Brussels
country: Belgium
facility: Hopital Erasme - Universite Libre de Bruxelles
city: Bielefeld
country: Germany
facility: Krankenhaus Mara, Gesellschaft für Epilepsieforschung e.V.
city: Freiburg
country: Germany
facility: Universität Klinikum Freibrug
city: Fazakerley
country: United Kingdom
facility: Walton Centre NHS Foundation Trust
state: Liverpool
Study officials:
affiliation: University of Pennsylvania
name: Michael Gelfand
role: PRINCIPAL_INVESTIGATOR
References: