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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03529045




Registration number
NCT03529045
Ethics application status
Date submitted
22/02/2018
Date registered
18/05/2018
Date last updated
9/05/2019

Titles & IDs
Public title
Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.
Scientific title
CORE-VNS: Comprehensive Outcomes Registry in Subjects With Epilepsy Treated With Vagus Nerve Stimulation Therapy
Secondary ID [1] 0 0
LNN-801
Universal Trial Number (UTN)
Trial acronym
CORE-VNS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Seizures 0 0
Drug Resistant Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Vagus Nerve Stimulation (VNS) Therapy

VNS Therapy - Any approved VNS Therapy System (according to local regulations) may be used in this registry.


Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Seizure Frequency - The average seizure frequency per month over the last 3 months (by type) will be collected
Timepoint [1] 0 0
Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Primary outcome [2] 0 0
Maximum Seizure Free Period - The maximum seizure free period over the last 3 months will be collected
Timepoint [2] 0 0
Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Primary outcome [5] 0 0
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
Timepoint [5] 0 0
Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Primary outcome [6] 0 0
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
Timepoint [6] 0 0
Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Primary outcome [7] 0 0
Anti-epileptic Drug Use - The name and dose of anti-epileptic drugs used will be collected on a case report form
Timepoint [7] 0 0
Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Primary outcome [8] 0 0
Rescue Drug Use - The number of times a rescue drug was used will be collected
Timepoint [8] 0 0
Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Primary outcome [9] 0 0
Seizure Related Emergency Department Visits - The number of times a patient had a seizure related emergency department (ED) visit will be collected
Timepoint [9] 0 0
Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Primary outcome [10] 0 0
Seizure Related Hospitalizations - The number of times a patient had a seizure related inpatient hospitalization and the length of each stay will be collected
Timepoint [10] 0 0
Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• There are no exclusion criteria in this study. Investigators should refer to the local
instructions for use for VNS Therapy.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Queensland Children's hospital - Brisbane
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Children's hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4101 - Brisbane
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3050 - Melbourne
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
West Virginia
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Austria
State/province [13] 0 0
Linz
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussels
Country [15] 0 0
Belgium
State/province [15] 0 0
Ghent
Country [16] 0 0
Israel
State/province [16] 0 0
Petach Tikva
Country [17] 0 0
Israel
State/province [17] 0 0
Ramat Gan
Country [18] 0 0
Israel
State/province [18] 0 0
Tel Aviv
Country [19] 0 0
Netherlands
State/province [19] 0 0
Heeze
Country [20] 0 0
Netherlands
State/province [20] 0 0
Zwolle
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Bristol
Country [22] 0 0
United Kingdom
State/province [22] 0 0
London
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Newcastle Upon Tyne
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Oxford
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
LivaNova
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy
and treated with the VNS Therapy System.
Trial website
https://clinicaltrials.gov/show/NCT03529045
Trial related presentations / 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.
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.
Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9.
Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshé 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, Gøtzsche 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.
Public notes

Contacts
Principal investigator
Name 0 0
Jason Jones, MS
Address 0 0
LivaNova USA, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Wim Van Grunderbeek
Address 0 0
Country 0 0
Phone 0 0
+32 2 245 40 67
Fax 0 0
Email 0 0
Wim.Vangrunderbeek@livanova.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03529045