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

NCT03529045 | Completed FDA Device

• 1 other identifier: LNN-801
• Study Type: observational
• Target: 827
• Locations: 15 countries
• Sites: 61

Brief Summary

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

Conditions

Epilepsy; Seizures; Drug Resistant Epilepsy

Keywords

VNS; VNS Therapy; Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

VNS Therapy

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

Device: Vagus Nerve Stimulation (VNS) Therapy

Interventions

Vagus Nerve Stimulation (VNS) Therapy DEVICE

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.

VNS Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

Sponsors & Collaborators

• LivaNova: lead

Study Sites (62)

St. Mary's Hospital

Grand Junction, Colorado, 81501, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Research Institute of Orlando

Orlando, Florida, 32806, United States

Location

Pediatric Epilepsy & Neurology Specialists

Tampa, Florida, 33609, United States

Location

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

Location

Via Christi Health

Wichita, Kansas, 67214, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Dent Neurosciences Research Center

Amherst, New York, 14226, United States

Location

State University of New York

Syracuse, New York, 13210, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny Neurology Associates

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

Child Neurology Consultants of Austin

Austin, Texas, 78731, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Valley Health System

Winchester, Virginia, 22601, United States

Location

Ascension Columbia St. Mary's Hospital

Milwaukee, Wisconsin, 53211, United States

Location

Queensland Children's hospital

Brisbane, Queensland, 4101, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

The Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Royal Children's hospital

Melbourne, Victoria, Australia

Location

Perth Children's Hospital

Perth, Western Australia, W1 6909, Australia

Location

Kepler Universitätsklinikum

Linz, 4020, Austria

Location

UCL Saint-Luc

Brussels, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Fundação Felice Rosso, Hospital Felício Rocho

Belo Horizonte, Brazil

Location

Instituto Estadual do Cérebro Paulo Niemeyer

Rio de Janeiro, Brazil

Location

London Health Sciences Centre Research Inc.

London, Ontario, N6A 5A5, Canada

Location

London Health Sciences Centre Research Inc. (London Victoria)

London, Ontario, N6C 2R5, Canada

Location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

Location

Montreal Neurological Institute and Hospital

Montreal, Quebec, H3A 2B4, Canada

Location

The Research Institute of the McGill University Health Centre

Montreal, Quebec, H3H 2R9, Canada

Location

Sanbo Brain Hospital Capital Medical University

Beijing, China

Location

Xuanwu Hospital Capital Medical University

Beijing, China

Location

Guangzhou Women and Children's Medical Center

Guangzhou, China

Location

P.D. Hinduja National Hospital

Mumbai, Maharashra, 400016, India

Location

Deenanath Mangeshkar Hospital and Research Centre

Pune, Maharashtra, 411004, India

Location

St.-John Medical College and Hospital

Bangalore, India

Location

Schneider Children's Medical Center of Israel

Petah Tikva, 4920235, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

Ospedale Bellaria

Bologna, 40139, Italy

Location

Bambino Gesu Pediatric Hospital

Rome, Italy

Location

National Center Hospital of Neurology and Psychiatry

Kodaira, Japan

Location

National Hospital Organization Nagasaki Medical Center

Nagasaki, Japan

Location

The University of Tokyo Hospital

Tokyo, Japan

Location

Kempenhaeghe

Heeze, Netherlands

Location

Sophia Kinderziekenhuis

Rotterdam, 3015 GD, Netherlands

Location

Stichting Epilepsie Instellingen Nederland (SEIN)

Zwolle, Netherlands

Location

University Clinical Center

Katowice, 40-752, Poland

Location

Children's Memorial Health Institute

Warsaw, 04-730, Poland

Location

Centro Hospitalar de São João

Porto, Portugal

Location

King Faisal Specialist Hospital & Research Center

Jeddah, Saudi Arabia

Location

King Faisal Specialist Hospital & Research Center

Riyadh, Saudi Arabia

Location

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

Royal Victoria Infirmary Hospital

Newcastle upon Tyne, United Kingdom

Location

Norfolk and Norwich Hospitals NHS Foundation Trust

Norwich, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, United Kingdom

Location

Related Publications (9)

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 27394056 BACKGROUND

• 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.

  PMID: 18478627 BACKGROUND

• Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.

  PMID: 10660394 BACKGROUND

• 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.

  PMID: 19889013 BACKGROUND

• 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.

  PMID: 11145319 BACKGROUND

• 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.

  PMID: 18064739 BACKGROUND

• 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.

  PMID: 35018342 RESULT

• 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.

  PMID: 39180426 RESULT

MeSH Terms

Conditions

Epilepsy; Seizures; Drug Resistant Epilepsy

Interventions

Vagus Nerve Stimulation; Therapeutics

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy

Study Officials

• Jeffrey Way

  LivaNova, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: May 18, 2018
• Study Start: February 5, 2018
• Primary Completion: September 11, 2024
• Study Completion: September 11, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); GB (6); IL (3); NL (3); AU (5); PL (2); IN (3); BR (2); CN (3); US (19); CA (5); JP (3); PT (1); SA (2); BE (2)