Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System. (CORE-VNS)

CORE-VNS: Comprehensive Outcomes Registry in Subjects With Epilepsy Treated With Vagus Nerve Stimulation Therapy

Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.

Study Overview

• Status: Active, not recruiting
• Conditions: Epilepsy; Seizures; Drug Resistant Epilepsy
• Intervention / Treatment: Device: Vagus Nerve Stimulation (VNS) Therapy

Detailed Description

The purpose of this registry is to evaluate clinical outcome and safety data in subjects with drug resistant epilepsy treated with the VNS Therapy System. The study will collect outcomes for subjects treated with VNS Therapy in a real-world setting.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4101
      • Queensland Children's Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3050
      • The Royal Melbourne Hospital
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
    • Melbourne, Victoria, Australia
      • Royal Children's Hospital
  • Western Australia
    • Perth, Western Australia, Australia, W1 6909
      • Perth Children's Hospital
• Austria
  • Linz, Austria, 4020
    • Kepler Universitätsklinikum
• Belgium
  • Brussels, Belgium
    • UCL Saint-Luc
  • Ghent, Belgium, 9000
    • Universitair Ziekenhuis Gent
• Brazil
  • Belo Horizonte, Brazil
    • Fundação Felice Rosso, Hospital Felício Rocho
  • Rio De Janeiro, Brazil
    • Instituto Estadual do Cérebro Paulo Niemeyer
• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre Research Inc.
    • London, Ontario, Canada, N6C 2R5
      • London Health Sciences Centre Research Inc. (London Victoria)
  • Quebec
    • Montréal, Quebec, Canada, H2X 0C1
      • Centre Hospitalier de l'Universite de Montreal
    • Montréal, Quebec, Canada, H3A 2B4
      • Montreal Neurological Institute and Hospital
    • Montréal, Quebec, Canada, H3H 2R9
      • The Research Institute of the McGill University Health Centre
• China
  • Beijing, China
    • Sanbo Brain Hospital Capital Medical University
  • Beijing, China
    • Xuanwu Hospital Capital Medical University
  • Guangzhou, China
    • Guangzhou Women And Children's Medical Center
• India
  • Bangalore, India
    • St.-John Medical College and Hospital
  • Maharashra
    • Mumbai, Maharashra, India, 400016
      • P.D. Hinduja National Hospital
  • Maharashtra
    • Pune, Maharashtra, India, 411004
      • Deenanath Mangeshkar Hospital and Research Centre
• Israel
  • Petach Tikva, Israel, 4920235
    • Schneider Children's Medical Center of Israel
  • Ramat Gan, Israel
    • Sheba Medical Center
  • Tel Aviv, Israel
    • Sourasky Medical Center
• Italy
  • Bologna, Italy, 40139
    • Ospedale Bellaria
  • Rome, Italy
    • Bambino Gesu Pediatric Hospital
• Japan
  • Kodaira, Japan
    • National Center Hospital of Neurology and Psychiatry
  • Nagasaki, Japan
    • National Hospital Organization Nagasaki Medical Center
  • Tokyo, Japan
    • The University of Tokyo Hospital
• Netherlands
  • Heeze, Netherlands
    • Kempenhaeghe
  • Rotterdam, Netherlands, 3015 GD
    • Sophia Kinderziekenhuis
  • Zwolle, Netherlands
    • Stichting Epilepsie Instellingen Nederland (SEIN)
• Poland
  • Katowice, Poland, 40-752
    • University Clinical Center
  • Warsaw, Poland, 04-730
    • Children's Memorial Health Institute
• Portugal
  • Porto, Portugal
    • Centro Hospitalar de São João
• Saudi Arabia
  • Jeddah, Saudi Arabia
    • King Faisal Specialist Hospital & Research Center
  • Riyadh, Saudi Arabia
    • King Faisal Specialist Hospital & Research Center
• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • Southmead Hospital
  • London, United Kingdom
    • King's College Hospital
  • Newcastle Upon Tyne, United Kingdom
    • Royal Victoria Infirmary Hospital
  • Norwich, United Kingdom
    • Norfolk and Norwich Hospitals NHS Foundation Trust
  • Oxford, United Kingdom
    • John Radcliffe Hospital
  • Sheffield, United Kingdom
    • Royal Hallamshire Hospital
• United States
  • Colorado
    • Grand Junction, Colorado, United States, 81501
      • St. Mary's Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Florida
    • Orlando, Florida, United States, 32806
      • Research Institute of Orlando
    • Tampa, Florida, United States, 33609
      • Pediatric Epilepsy & Neurology Specialists
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Hawaii Pacific Neuroscience
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Via Christi Health
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurosciences Research Center
    • Syracuse, New York, United States, 13210
      • State University of New York
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Neurology Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Le Bonheur Children's Hospital
  • Texas
    • Austin, Texas, United States, 78731
      • Child Neurology Consultants of Austin
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio
  • Virginia
    • Winchester, Virginia, United States, 22601
      • Valley Health System
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53211
      • Ascension Columbia St. Mary's Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System. Eligible subjects include those receiving VNS Therapy for the first time, as well as those that are being re-implanted with VNS

Description

Inclusion Criteria:

• Clinical diagnosis of drug resistant epilepsy treated with VNS Therapy. Eligible subjects include those not previously treated with VNS Therapy as well as subjects receiving replacement generators.
• Able and willing to comply with the frequency of study visits.
• Subject, or legal guardian, understands study procedures and voluntarily signs an informed consent in accordance with institutional policies. In the event that the subject is under the age of 18, the subject may also be required (per EC/IRB) to sign an assent affirming their agreement to participate.

Exclusion Criteria:

• There are no exclusion criteria in this study. Investigators should refer to the local instructions for use for VNS Therapy.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VNS Therapy; Any approved VNS Therapy System (according to local regulations) may be used in this registry.	Device: Vagus Nerve Stimulation (VNS) Therapy; The VNS Therapy System is a commercially available device that will be used by licensed medical practitioners trained in the use of VNS Therapy, per the practitioners' medical judgement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure Frequency	The average seizure frequency per month over the last 3 months (by type) will be collected	Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Maximum Seizure Free Period	The maximum seizure free period over the last 3 months will be collected	Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Seizure Severity	Seizure severity is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe	Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Post-ictal Severity	Seizure severity is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe	Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Change in Quality of Life	Quality of life is a categorical outcome and will be rated by the subject using the following categories: Very good: could hardly be better, Pretty good, Good and bad parts about equal, Pretty bad, Very bad: could hardly be worse	Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Quality of Sleep	Quality of sleep will be reported using the Pittsburgh Sleep Quality Index for subjects 18 years and older and using the Children's Sleep Habit Questionnaire for subjects 2-17 years old; quality of sleep will not be assessed in children under 2 years old	Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Anti-epileptic Drug Use	The name and dose of anti-epileptic drugs used will be collected on a case report form	Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Rescue Drug Use	The number of times a rescue drug was used will be collected	Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Seizure Related Emergency Department Visits	The number of times a patient had a seizure related emergency department (ED) visit will be collected	Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Seizure Related Hospitalizations	The number of times a patient had a seizure related inpatient hospitalization and the length of each stay will be collected	Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable

Collaborators and Investigators

• Sponsor: LivaNova
• Investigators: Study Director: Kathryn Nichol, LivaNova, Inc.

Publications and helpful links

General Publications

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
• Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.
• Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3. Erratum In: Epilepsia. 2010 Sep;51(9):1922.
• Owens JA, Spirito A, McGuinn M. The Children's Sleep Habits Questionnaire (CSHQ): psychometric properties of a survey instrument for school-aged children. Sleep. 2000 Dec 15;23(8):1043-51.
• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.
• Ekinci O, Isik U, Gunes S, Ekinci N. Understanding sleep problems in children with epilepsy: Associations with quality of life, Attention-Deficit Hyperactivity Disorder and maternal emotional symptoms. Seizure. 2016 Aug;40:108-13. doi: 10.1016/j.seizure.2016.06.011. Epub 2016 Jun 27.
• Goodlin-Jones BL, Sitnick SL, Tang K, Liu J, Anders TF. The Children's Sleep Habits Questionnaire in toddlers and preschool children. J Dev Behav Pediatr. 2008 Apr;29(2):82-88. doi: 10.1097/dbp.0b013e318163c39a.
• Sen A, Verner R, Valeriano JP, Lee R, Zafar M, Thomas R, Kotulska K, Jespers E, Dibue M, Kwan P; CORE-VNS Registry Group. Vagus nerve stimulation therapy in people with drug-resistant epilepsy (CORE-VNS): rationale and design of a real-world post-market comprehensive outcomes registry. BMJ Neurol Open. 2021 Dec 23;3(2):e000218. doi: 10.1136/bmjno-2021-000218. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Anticipated): October 30, 2024
• Study Completion (Anticipated): April 30, 2025

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: May 7, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Vagus Nerve Stimulation; VNS Therapy; VNS
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Drug Resistant Epilepsy
• Other Study ID Numbers: LNN-801

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: Yes
• product manufactured in and exported from the U.S.: Yes