Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.
NCT ID: NCT03529045
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
827 participants
OBSERVATIONAL
2018-02-05
2024-09-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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VNS Therapy
Any approved VNS Therapy System (according to local regulations) may be used in this registry.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
ALL
No
Sponsors
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LivaNova
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey Way
Role: STUDY_DIRECTOR
LivaNova, Inc.
Locations
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St. Mary's Hospital
Grand Junction, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Research Institute of Orlando
Orlando, Florida, United States
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Via Christi Health
Wichita, Kansas, United States
Tulane University
New Orleans, Louisiana, United States
Dent Neurosciences Research Center
Amherst, New York, United States
State University of New York
Syracuse, New York, United States
Duke University Hospital
Durham, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny Neurology Associates
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Child Neurology Consultants of Austin
Austin, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Valley Health System
Winchester, Virginia, United States
Ascension Columbia St. Mary's Hospital
Milwaukee, Wisconsin, United States
Queensland Children's hospital
Brisbane, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Melbourne, Victoria, Australia
Royal Children's hospital
Melbourne, Victoria, Australia
Perth Children's Hospital
Perth, Western Australia, Australia
Kepler Universitätsklinikum
Linz, , Austria
UCL Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Fundação Felice Rosso, Hospital Felício Rocho
Belo Horizonte, , Brazil
Instituto Estadual do Cérebro Paulo Niemeyer
Rio de Janeiro, , Brazil
London Health Sciences Centre Research Inc.
London, Ontario, Canada
London Health Sciences Centre Research Inc. (London Victoria)
London, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
The Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
Sanbo Brain Hospital Capital Medical University
Beijing, , China
Xuanwu Hospital Capital Medical University
Beijing, , China
Guangzhou Women and Children's Medical Center
Guangzhou, , China
P.D. Hinduja National Hospital
Mumbai, Maharashra, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, India
St.-John Medical College and Hospital
Bangalore, , India
Schneider Children's Medical Center of Israel
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Ospedale Bellaria
Bologna, , Italy
Bambino Gesu Pediatric Hospital
Rome, , Italy
National Center Hospital of Neurology and Psychiatry
Kodaira, , Japan
National Hospital Organization Nagasaki Medical Center
Nagasaki, , Japan
The University of Tokyo Hospital
Tokyo, , Japan
Kempenhaeghe
Heeze, , Netherlands
Sophia Kinderziekenhuis
Rotterdam, , Netherlands
Stichting Epilepsie Instellingen Nederland (SEIN)
Zwolle, , Netherlands
University Clinical Center
Katowice, , Poland
Children's Memorial Health Institute
Warsaw, , Poland
Centro Hospitalar de São João
Porto, , Portugal
King Faisal Specialist Hospital & Research Center
Jeddah, , Saudi Arabia
King Faisal Specialist Hospital & Research Center
Riyadh, , Saudi Arabia
Southmead Hospital
Bristol, , United Kingdom
King's College Hospital
London, , United Kingdom
Royal Victoria Infirmary Hospital
Newcastle upon Tyne, , United Kingdom
Norfolk and Norwich Hospitals NHS Foundation Trust
Norwich, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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LNN-801
Identifier Type: -
Identifier Source: org_study_id
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