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

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ClinicalTrials.gov Identifier: NCT03529045
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
LivaNova

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

Condition or disease Intervention/treatment
Epilepsy Seizures Drug Resistant Epilepsy 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 [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: CORE-VNS: Comprehensive Outcomes Registry in Subjects With Epilepsy Treated With Vagus Nerve Stimulation Therapy
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : March 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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.




Primary Outcome Measures :
  1. Seizure Frequency [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The average seizure frequency per month over the last 3 months (by type) will be collected

  2. Maximum Seizure Free Period [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The maximum seizure free period over the last 3 months will be collected

  3. Seizure Severity [ Time Frame: 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 is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe

  4. Post-ictal Severity [ Time Frame: 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 is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe

  5. Quality of Life [ Time Frame: 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 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

  6. Quality of Sleep [ Time Frame: 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 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

  7. Anti-epileptic Drug Use [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The name and dose of anti-epileptic drugs used will be collected on a case report form

  8. Rescue Drug Use [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The number of times a rescue drug was used will be collected

  9. Seizure Related Emergency Department Visits [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The number of times a patient had a seizure related emergency department (ED) visit will be collected

  10. Seizure Related Hospitalizations [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The number of times a patient had a seizure related inpatient hospitalization and the length of each stay will be collected



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529045


Contacts
Contact: Ljubomir Manola, PhD +32 2 715 93 12 ljubomir.manola@livanova.com
Contact: Shannon Majewski 817-771-9195 shannon.majewski@livanova.com

Locations
United States, Florida
Pediatric Epilepsy & Neurology Specialists Recruiting
Tampa, Florida, United States, 33609
Contact: Mayra Ferreira    813-873-7367 ext 210    mayra@pensresearch.org   
Principal Investigator: Jose Ferreira         
United States, Hawaii
Hawaii Pacific Neuroscience Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Catherine Chao    808-564-6142    cchao@hawaiineuroscience.com   
Principal Investigator: Kore Liow, MD         
United States, North Carolina
Onsite Clinical Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Brooke Withers    704-600-7764    bwithers@onsiteclinical.com   
Principal Investigator: Robert Nahouraii, MD         
United States, Virginia
Winchester Medical Center Recruiting
Winchester, Virginia, United States, 22601
Contact: Anne Ganse    540-536-6518    aganse@valleyhealthlink.com   
Principal Investigator: Paul Lyons         
Sponsors and Collaborators
LivaNova
Investigators
Study Director: Jason Jones, MS LivaNova USA, Inc.

Publications:

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT03529045     History of Changes
Other Study ID Numbers: LNN-801
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by LivaNova:
VNS
VNS Therapy
Vagus Nerve Stimulation

Additional relevant MeSH terms:
Epilepsy
Seizures
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms