Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.

Epilepsy Clinical Trial

— CORE-VNS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03529045
• Other study ID #: LNN-801
• Status: Active, not recruiting
• Start date: February 5, 2018
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2023
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: April 30, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Seizures

Intervention

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.

Locations

Country	Name	City	State
Australia	Queensland Children's hospital	Brisbane	Queensland
Australia	Royal Children's hospital	Melbourne	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	The Royal Melbourne Hospital	Melbourne	Victoria
Australia	Perth Children's Hospital	Perth	Western Australia
Austria	Kepler Universitätsklinikum	Linz
Belgium	UCL Saint-Luc	Brussels
Belgium	Universitair Ziekenhuis Gent	Ghent
Brazil	Fundação Felice Rosso, Hospital Felício Rocho	Belo Horizonte
Brazil	Instituto Estadual do Cérebro Paulo Niemeyer	Rio De Janeiro
Canada	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	Montréal	Quebec
Canada	Montreal Neurological Institute and Hospital	Montréal	Quebec
Canada	The Research Institute of the McGill University Health Centre	Montréal	Quebec
China	Sanbo Brain Hospital Capital Medical University	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing
China	Guangzhou Women and Children's Medical Center	Guangzhou
India	St.-John Medical College and Hospital	Bangalore
India	P.D. Hinduja National Hospital	Mumbai	Maharashra
India	Deenanath Mangeshkar Hospital and Research Centre	Pune	Maharashtra
Israel	Schneider Children's Medical Center of Israel	Petach Tikva
Israel	Sheba Medical Center	Ramat Gan
Israel	Sourasky Medical Center	Tel Aviv
Italy	Ospedale Bellaria	Bologna
Italy	Bambino Gesu Pediatric Hospital	Rome
Japan	National Center Hospital of Neurology and Psychiatry	Kodaira
Japan	National Hospital Organization Nagasaki Medical Center	Nagasaki
Japan	The University of Tokyo Hospital	Tokyo
Netherlands	Kempenhaeghe	Heeze
Netherlands	Sophia Kinderziekenhuis	Rotterdam
Netherlands	Stichting Epilepsie Instellingen Nederland (SEIN)	Zwolle
Poland	University Clinical Center	Katowice
Poland	Children's Memorial Health Institute	Warsaw
Portugal	Centro Hospitalar de São João	Porto
Saudi Arabia	King Faisal Specialist Hospital & Research Center	Jeddah
Saudi Arabia	King Faisal Specialist Hospital & Research Center	Riyadh
United Kingdom	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 States	Dent Neurosciences Research Center	Amherst	New York
United States	Child Neurology Consultants of Austin	Austin	Texas
United States	Duke University Hospital	Durham	North Carolina
United States	St. Mary's Hospital	Grand Junction	Colorado
United States	Hawaii Pacific Neuroscience	Honolulu	Hawaii
United States	Le Bonheur Children's Hospital	Memphis	Tennessee
United States	Ascension Columbia St. Mary's Hospital	Milwaukee	Wisconsin
United States	Tulane University	New Orleans	Louisiana
United States	Research Institute of Orlando	Orlando	Florida
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	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	State University of New York	Syracuse	New York
United States	Pediatric Epilepsy & Neurology Specialists	Tampa	Florida
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Via Christi Health	Wichita	Kansas
United States	Valley Health System	Winchester	Virginia
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  India,  Israel,  Italy,  Japan,  Netherlands,  Poland,  Portugal,  Saudi Arabia,  United Kingdom, 

References & Publications (7)

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. — View 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. — View 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. — View 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. Erratum In: Epilepsia. 2010 Sep;51(9):1922. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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