Clinical trial NCT03529045: Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.
Official title: CORE-VNS: Comprehensive Outcomes Registry in Subjects With Epilepsy Treated With Vagus Nerve Stimulation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Seizures
Drug Resistant Epilepsy
Keywords: VNS
VNS Therapy
Vagus Nerve Stimulation
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2018-05-18
Enrollment: 827
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Eligibility 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.

Primary outcomes:
measure: Seizure Frequency
timeFrame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
measure: Maximum Seizure Free Period
timeFrame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
measure: Seizure Severity
timeFrame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
measure: Post-ictal Severity
timeFrame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
measure: Change in Quality of Life
timeFrame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
measure: Quality of Sleep
timeFrame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
measure: Anti-epileptic Drug Use
timeFrame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
measure: Rescue Drug Use
timeFrame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
measure: Seizure Related Emergency Department Visits
timeFrame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
measure: Seizure Related Hospitalizations
timeFrame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Junction
country: United States
facility: St. Mary's Hospital
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Orlando
country: United States
facility: Research Institute of Orlando
state: Florida
city: Tampa
country: United States
facility: Pediatric Epilepsy & Neurology Specialists
state: Florida
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience
state: Hawaii
city: Wichita
country: United States
facility: Via Christi Health
state: Kansas
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Amherst
country: United States
facility: Dent Neurosciences Research Center
state: New York
city: Syracuse
country: United States
facility: State University of New York
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Neurology Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
city: Austin
country: United States
facility: Child Neurology Consultants of Austin
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Winchester
country: United States
facility: Valley Health System
state: Virginia
city: Milwaukee
country: United States
facility: Ascension Columbia St. Mary's Hospital
state: Wisconsin
city: Brisbane
country: Australia
facility: Queensland Children's hospital
state: Queensland
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Royal Children's hospital
state: Victoria
city: Perth
country: Australia
facility: Perth Children's Hospital
state: Western Australia
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Brussels
country: Belgium
facility: UCL Saint-Luc
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Belo Horizonte
country: Brazil
facility: Fundação Felice Rosso, Hospital Felício Rocho
city: Rio De Janeiro
country: Brazil
facility: Instituto Estadual do Cérebro Paulo Niemeyer
city: London
country: Canada
facility: London Health Sciences Centre Research Inc.
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre Research Inc. (London Victoria)
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Montréal
country: Canada
facility: Montreal Neurological Institute and Hospital
state: Quebec
city: Montréal
country: Canada
facility: The Research Institute of the McGill University Health Centre
state: Quebec
city: Beijing
country: China
facility: Sanbo Brain Hospital Capital Medical University
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
city: Mumbai
country: India
facility: P.D. Hinduja National Hospital
state: Maharashra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
state: Maharashtra
city: Bangalore
country: India
facility: St.-John Medical College and Hospital
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Bologna
country: Italy
facility: Ospedale Bellaria
city: Rome
country: Italy
facility: Bambino Gesu Pediatric Hospital
city: Kodaira
country: Japan
facility: National Center Hospital of Neurology and Psychiatry
city: Nagasaki
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
city: Tokyo
country: Japan
facility: The University of Tokyo Hospital
city: Heeze
country: Netherlands
facility: Kempenhaeghe
city: Rotterdam
country: Netherlands
facility: Sophia Kinderziekenhuis
city: Zwolle
country: Netherlands
facility: Stichting Epilepsie Instellingen Nederland (SEIN)
city: Katowice
country: Poland
facility: University Clinical Center
city: Warsaw
country: Poland
facility: Children's Memorial Health Institute
city: Porto
country: Portugal
facility: Centro Hospitalar de São João
city: Jeddah
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich Hospitals NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
Study officials:
affiliation: LivaNova, Inc.
name: Jeffrey Way
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Kwan P, Boffini M, Fahoum F, El Tahry R, O'Brien TJ, Keough K, Boggs J, Goldberg-Stern H, Beraldi F, Giannicola G, Lee YC, Sen A; CORE-VNS Registry Group. Baseline characteristics and predictors for early implantation of vagus nerve stimulation therapy in people with drug-resistant epilepsy: Observations from an international prospective outcomes registry (CORE-VNS). Epilepsia Open. 2024 Oct;9(5):1837-1846. doi: 10.1002/epi4.13015. Epub 2024 Aug 24.