CORE-VNS: Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.
Study Details
Study Description
Brief Summary
Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| VNS Therapy Any approved VNS Therapy System (according to local regulations) may be used in this registry. |
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.
|
Outcome Measures
Primary Outcome Measures
- Seizure Frequency [Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable]
The average seizure frequency per month over the last 3 months (by type) will be collected
- Maximum Seizure Free Period [Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable]
The maximum seizure free period over the last 3 months will be collected
- Seizure Severity [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 is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe
- Post-ictal Severity [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 is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe
- Change in Quality of Life [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 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
- Quality of Sleep [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 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
- Anti-epileptic Drug Use [Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable]
The name and dose of anti-epileptic drugs used will be collected on a case report form
- Rescue Drug Use [Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable]
The number of times a rescue drug was used will be collected
- Seizure Related Emergency Department Visits [Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable]
The number of times a patient had a seizure related emergency department (ED) visit will be collected
- Seizure Related Hospitalizations [Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable]
The number of times a patient had a seizure related inpatient hospitalization and the length of each stay will be collected
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Mary's Hospital | Grand Junction | Colorado | United States | 81501 |
| 2 | Georgetown University Medical Center | Washington | District of Columbia | United States | 20007 |
| 3 | Research Institute of Orlando | Orlando | Florida | United States | 32806 |
| 4 | Pediatric Epilepsy & Neurology Specialists | Tampa | Florida | United States | 33609 |
| 5 | Hawaii Pacific Neuroscience | Honolulu | Hawaii | United States | 96817 |
| 6 | Via Christi Health | Wichita | Kansas | United States | 67214 |
| 7 | Dent Neurosciences Research Center | Amherst | New York | United States | 14226 |
| 8 | State University of New York | Syracuse | New York | United States | 13210 |
| 9 | Onsite Clinical Solutions, LLC | Charlotte | North Carolina | United States | 28277 |
| 10 | Duke University Hospital | Durham | North Carolina | United States | 27710 |
| 11 | Wake Forest University | Winston-Salem | North Carolina | United States | 27157 |
| 12 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 13 | Allegheny Neurology Associates | Pittsburgh | Pennsylvania | United States | 15212 |
| 14 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
| 15 | Le Bonheur Children's Hospital | Memphis | Tennessee | United States | 38103 |
| 16 | Child Neurology Consultants of Austin | Austin | Texas | United States | 78731 |
| 17 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229 |
| 18 | Valley Health System | Winchester | Virginia | United States | 22601 |
| 19 | Ascension Columbia St. Mary's Hospital | Milwaukee | Wisconsin | United States | 53211 |
| 20 | Queensland Children's hospital | Brisbane | Queensland | Australia | 4101 |
| 21 | The Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
| 22 | The Royal Melbourne Hospital | Melbourne | Victoria | Australia | 3050 |
| 23 | Royal Children's hospital | Melbourne | Victoria | Australia | |
| 24 | Perth Children's Hospital | Perth | Western Australia | Australia | W1 6909 |
| 25 | Kepler Universitätsklinikum | Linz | Austria | 4020 | |
| 26 | UCL Saint-Luc | Brussels | Belgium | ||
| 27 | Universitair Ziekenhuis Gent | Ghent | Belgium | 9000 | |
| 28 | Fundação Felice Rosso, Hospital Felício Rocho | Belo Horizonte | Brazil | ||
| 29 | Instituto Estadual do Cérebro Paulo Niemeyer | Rio De Janeiro | Brazil | ||
| 30 | London Health Sciences Centre Research Inc. | London | Ontario | Canada | N6A 5A5 |
| 31 | London Health Sciences Centre Research Inc. (London Victoria) | London | Ontario | Canada | N6C 2R5 |
| 32 | Centre Hospitalier de l'Université de Montréal | Montréal | Quebec | Canada | H2X 0C1 |
| 33 | Montreal Neurological Institute and Hospital | Montréal | Quebec | Canada | H3A 2B4 |
| 34 | The Research Institute of the McGill University Health Centre | Montréal | Quebec | Canada | H3H 2R9 |
| 35 | Sanbo Brain Hospital Capital Medical University | Beijing | China | ||
| 36 | Xuanwu Hospital Capital Medical University | Beijing | China | ||
| 37 | Guangzhou Women and Children's Medical Center | Guangzhou | China | ||
| 38 | Renji Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | China | ||
| 39 | P.D. Hinduja National Hospital | Mumbai | Maharashra | India | 400016 |
| 40 | Deenanath Mangeshkar Hospital and Research Centre | Pune | Maharashtra | India | 411004 |
| 41 | St.-John Medical College and Hospital | Bangalore | India | ||
| 42 | Schneider Children's Medical Center of Israel | Petach Tikva | Israel | 4920235 | |
| 43 | Sheba Medical Center | Ramat Gan | Israel | ||
| 44 | Sourasky Medical Center | Tel Aviv | Israel | ||
| 45 | Ospedale Bellaria | Bologna | Italy | 40139 | |
| 46 | Bambino Gesu Pediatric Hospital | Rome | Italy | ||
| 47 | National Center Hospital of Neurology and Psychiatry | Kodaira | Japan | ||
| 48 | National Hospital Organization Nagasaki Medical Center | Nagasaki | Japan | ||
| 49 | The University of Tokyo Hospital | Tokyo | Japan | ||
| 50 | Kempenhaeghe | Heeze | Netherlands | ||
| 51 | Sophia Kinderziekenhuis | Rotterdam | Netherlands | 3015 GD | |
| 52 | Stichting Epilepsie Instellingen Nederland (SEIN) | Zwolle | Netherlands | ||
| 53 | University Clinical Center | Katowice | Poland | 40-752 | |
| 54 | Children's Memorial Health Institute | Warsaw | Poland | 04-730 | |
| 55 | Centro Hospitalar de São João | Porto | Portugal | ||
| 56 | King Faisal Specialist Hospital & Research Center | Jeddah | Saudi Arabia | ||
| 57 | King Faisal Specialist Hospital & Research Center | Riyadh | Saudi Arabia | ||
| 58 | Southmead Hospital | Bristol | United Kingdom | BS10 5NB | |
| 59 | King's College Hospital | London | United Kingdom | ||
| 60 | Royal Victoria Infirmary Hospital | Newcastle Upon Tyne | United Kingdom | ||
| 61 | Norfolk and Norwich Hospitals NHS Foundation Trust | Norwich | United Kingdom | ||
| 62 | John Radcliffe Hospital | Oxford | United Kingdom | ||
| 63 | Royal Hallamshire Hospital | Sheffield | United Kingdom |
Sponsors and Collaborators
- LivaNova
Investigators
- Study Director: Ana Cebrian, LivaNova, Inc.
Study Documents (Full-Text)
None provided.More Information
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, 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.
- Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9.
- 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.
- LNN-801