Product Surveillance Registry- Deep Brain Stimulation for Epilepsy (MORE)
This study is currently recruiting participants.
Verified April 2013 by Medtronic International Trading Sarl
Sponsor:
Medtronic International Trading Sarl
Information provided by (Responsible Party):
Medtronic International Trading Sarl
ClinicalTrials.gov Identifier:
NCT01521754
First received: January 13, 2012
Last updated: April 30, 2013
Last verified: April 2013
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Purpose
The purpose of this observational registry is to evaluate the long-term effectiveness, safety and performance of market-released Medtronic Neuromodulation products for Deep Brain Stimulation (DBS) for the treatment of refractory epilepsy. In addition, healthcare resource use and patient reported outcomes, such as health related quality of life will be assessed.
| Condition |
|---|
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Refractory Epilepsy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | Medtronic Registry for Epilepsy (MORE) |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
U.S. FDA Resources
Further study details as provided by Medtronic International Trading Sarl:
Primary Outcome Measures:
- Seizure rate [ Time Frame: Participants will be followed for the duration of the registry, an expected average of 3 years ] [ Designated as safety issue: No ]Evaluate the change in seizure rate from baseline over 2 years following DBS implant.
Secondary Outcome Measures:
- Seizure type and severity [ Time Frame: Participants will be followed for the duration of the registry, an expected average of 3 years ] [ Designated as safety issue: No ]To characterize seizure type and severity
- Depression score assessment [ Time Frame: Participants will be followed for the duration of the registry, an expected average of 3 years ] [ Designated as safety issue: No ]To evaluate changes in depression score over time. BDI-II score is obtained by adding the score circled for each of the 21 items, the change of the BDI-II score is calculated as the difference between value at baseline phase and follow-up visits
- Health Related Quality of Life (HRQoL) [ Time Frame: Participants will be followed for the duration of the registry, an expected average of 3 years ] [ Designated as safety issue: No ]To assess the change in health-related quality of life following DBS by means of QOLIE-31 (Quality of life in epilepsy-31) and SF-36 (Short-form 36)
- Adverse Events characterization [ Time Frame: Participants will be followed for the duration of the registry, an expected average of 3 years ] [ Designated as safety issue: Yes ]To assess adverse events related to the device, implant procedure, and/or therapy.
| Estimated Enrollment: | 200 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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Perspective
Prospective cohort: new patients who are initially implanted with a Medtronic neurostimulation system on or after a site's activation date. The classification is static and will not change in the case of a re-implant.
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Retrospective
Retrospective cohort: existing patients comprised the sub-group of patients who were implanted with a Medtronic neurostimulation system prior to a site's activation date. This cohort contains a part of retrospective data and a part of prospective data according to the enrolment date. The classification is static and will not change even when an existing patient will be subsequently re-implanted after the site's activation date.
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adults diagnosed with refractory epilepsy characterized by partial-onset seizures, with or without secondary generalization
Criteria
Inclusion Criteria:
- Fulfilling the criteria of labeling indications of Medtronic® DBS™ Therapy for Epilepsy.
- Patient with diagnosis of refractory epilepsy as defined by 1981 ILAE (International League Against Epilepsy) classification, who have been implanted or will be implanted with Medtronic® DBS™ Therapy for Epilepsy.
- For both cohorts, completed at least two full months diary information on seizure type and frequency prior to DBS implant (seizure type should be classified at least as simple partial, complex partial, partial evolving to secondarily generalized seizures, and generalized). In regard to the prospective cohort, the patient will be conditionally enrolled at the enrolment visit, and the criterion will be reassessed at the baseline visit.
- Patient or patient's legally authorized representative able to understand and to provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC or local law and regulations.
Exclusion Criteria:
- Incomplete and/or unreliable patient seizure diary based on the physician's judgment
- Pregnancy at time of enrollment
- Patient is currently enrolled in or plans to enroll in any concurrent drug, surgery and/or device study that may confound the results of this registry.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521754
Locations
| Austria | |
| Medizinische Universität Wien | Not yet recruiting |
| Vienna, Austria, 1090 | |
| Contact: Ekaterina Pataraia, Dr. ekaterina.pataraia@meduniwien.ac.at | |
| Finland | |
| University & Hospital of Tampere - Neurology and Rehabilitation | Not yet recruiting |
| Tampere, Finland, 33521 | |
| Contact: Jukka Peltola, Dr. jukka.peltola@pshp.fi | |
| Germany | |
| Universitätsklinikum Bonn -AöR- | Recruiting |
| Bonn, Germany, 53105 | |
| Contact: Christian Elger, Prof. christian.elger@ukb.uni-bonn.de | |
| University Hospital Freiburg | Recruiting |
| Freiburg, Germany, 79106 | |
| Contact: Andreas Schulze-Bonhage, Prof. andreas.schulze-bonhage@uniklinik-freiburg.de | |
| Universitätsklinikum Schleswig-Holstein Campus Kiel | Recruiting |
| Kiel, Germany, 24105 | |
| Contact: Nicolas Lang, Dr. n.lang@neurologie.uni-kiel.de | |
| Klinikum der Universität München -Großhadern | Recruiting |
| Munich, Germany, 81377 | |
| Contact: Sohey Noachtar, Prof. Soheyl.Noachtar@med.uni-muenchen.de | |
| University Hospital Tübingen | Recruiting |
| Tübingen, Germany, 72076 | |
| Contact: Sabine Rona, Dr. Sabine.Rona@med.uni-tuebingen.de | |
| Principal Investigator: Sabine Rona, Dr. | |
| Hungary | |
| University of Pécs Clinical Centre (PTE KK) | Recruiting |
| Pécs, Hungary, 7624 | |
| Contact: József Janszky, Prof. jozsef.janszky@gmail.com | |
| Italy | |
| AZ. Ospedaliero-Universitario-Ospedali Riuniti | Not yet recruiting |
| Ancona, Italy, 60020 | |
| Contact: Massimo Scerrati, Prof. | |
| AO Niguarda Ca' Granda | Recruiting |
| Milano, Italy, 20162 | |
| Contact: Giorgio Lo Russo, Dr. giorgio.lorusso@ospedaleniguarda.it | |
| AO Santa Maria della Misericordia di Udine | Recruiting |
| Udine, Italy, 33100 | |
| Contact: Roberto Eleopra, Dr. eleopra.roberto@aoud.sanita.fvg.it | |
| Netherlands | |
| Medisch Spectrum Twente | Recruiting |
| Enschede, Netherlands, 7513 ER | |
| Contact: Gerard Hageman, Dr. G.Hageman@mst.nl | |
| Expertisecentrum Voor Epileptologie-Kempenhaeghe | Recruiting |
| Heeze, Netherlands, 65 5591 VE | |
| Contact: Paul Boon, Prof. Paul.Boon@uzgent.be | |
| Poland | |
| Szpital Uniwersytecki w Krakowie - Neurology | Recruiting |
| Krakow, Poland, 31-503 | |
| Contact: Magdalena Bosak, Dr magdalenabosak@wp.pl | |
| Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie | Recruiting |
| Lublin, Poland, 20-954 | |
| Contact: Jacek Gawlowicz, Dr. jgawlowicz@yahoo.com | |
| Portugal | |
| Hospital de Santa Maria | Recruiting |
| Lisbon, Portugal, 1649-035 | |
| Contact: Antonio Gonçalves Ferreira, Prof. ajgonfer@fm.ul.pt | |
| Centro Hospitalar de São João E.P.E. | Recruiting |
| Porto, Portugal, 4200-319 | |
| Contact: Rui Vaz, Prof. ruimcvaz@gmail.com | |
| Sweden | |
| Karolinska University Hospital | Recruiting |
| Stockholm, Sweden, 17176 | |
| Contact: Lisa Gordon, Dr. Lisa.gordon@karolinska.se | |
| United Kingdom | |
| University Hospitals Birmingham NHS Foundation Trust | Not yet recruiting |
| Birmingham, United Kingdom, B15 2TH | |
| Contact: Dougall McCorry, Dr dougall.mccorry@uhb.nhs.uk | |
| Frenchay Hospital | Not yet recruiting |
| Bristol, United Kingdom, BS16 1LE | |
| Contact: Nik Patel, Dr nik.patel@nbt.nhs.uk | |
| Ninewells Hospital | Not yet recruiting |
| Dundee, United Kingdom, DD1 9SY | |
| Contact: Sam Eljamel, Dr m.s.eljamel@dundee.ac.uk | |
| Charing Cross Hospital | Not yet recruiting |
| London, United Kingdom, W 8BE | |
| Contact: Nicola Pavese, Dr. nicola.pavese@csc.mrc.ac.uk | |
| Royal Victoria Infirmary | Not yet recruiting |
| Newcastle, United Kingdom, NE1 4LP | |
| Contact: Yvonne Hart, Dr yvonne.hart@nuth.nhs.uk | |
| Royal Hallamshire Hospital | Not yet recruiting |
| Sheffield, United Kingdom, S10 2JF | |
| Contact: Jeremy Rowe, Dr jeremy.rowe@sch.nhs.uk | |
Sponsors and Collaborators
Medtronic International Trading Sarl
Investigators
| Study Chair: | Massimiliano Malloni | Medtronic International Trading Sarl Neuromodulation |
More Information
No publications provided
| Responsible Party: | Medtronic International Trading Sarl |
| ClinicalTrials.gov Identifier: | NCT01521754 History of Changes |
| Other Study ID Numbers: | 1.02.9001, Addendum C.AD.1 |
| Study First Received: | January 13, 2012 |
| Last Updated: | April 30, 2013 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) Germany: Ethics Commission Portugal: Ethics Committee for Clinical Research Austria: Ethikkommission Italy: Ethics Committee Finland: Ethics Committee Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines Sweden: Regional Ethical Review Board Spain: Ethics Committee Poland: Ethics Committee |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013