Product Surveillance Registry- Deep Brain Stimulation for Epilepsy (MORE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Medtronic International Trading Sarl
Information provided by (Responsible Party):
Medtronic International Trading Sarl Identifier:
First received: January 13, 2012
Last updated: April 9, 2015
Last verified: November 2014

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.

Refractory Epilepsy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Medtronic Registry for Epilepsy (MORE)

Resource links provided by NLM:

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)
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.
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.

  Show Detailed Description


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


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 consecutive 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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01521754

Contact: Ariane Beaumann +41 (0)21 803 8467
Contact: Gregory Beth

Medizinische Universität Wien Recruiting
Vienna, Austria, 1090
Contact: Ekaterina Pataraia, Dr.    0043-1 40400 ext 3433/3139   
Principal Investigator: Ekaterina Pataraia, MD         
University & Hospital of Tampere - Neurology and Rehabilitation Recruiting
Tampere, Finland, 33521
Contact: Jukka Peltola, Dr.    +358 33 11 64 713   
Principal Investigator: Jukka Peltola, MD         
Universitätsklinikum Bonn -AöR- Recruiting
Bonn, Germany, 53105
Contact: Christian Elger, Prof.    0049 (0228) 287 11574   
Principal Investigator: Christian Elger, MD         
University Hospital Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Andreas Schulze-Bonhage, Prof.    0049 (0)761-270 ext 54250   
Principal Investigator: Andreas Schulze-Bonhage, MD         
Neurologie und Epilepsiezentrum Hamburg Not yet recruiting
Hamburg, Germany, 22337
Contact: Stefan Stodieck, MD    +49 -40- 5077 3507   
Principal Investigator: Stefan Stodieck, MD         
Universitätsklinikum Schleswig-Holstein Campus Kiel Recruiting
Kiel, Germany, 24105
Contact: Nicolas Lang, Dr.    0049 431 597 8550   
Principal Investigator: Nicolas Lang, MD         
Klinikum der Universität München -Großhadern Recruiting
Munich, Germany, 81377
Contact: Soheyl Noachtar, Prof.    0049 89 7095 ext 3691   
Principal Investigator: Soheyl Noachtar, MD         
University Hospital Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Sabine Rona, Dr.   
Principal Investigator: Sabine Rona, Dr.         
Országos Idegtudományi Intézet / National Institute of Neurosciences Recruiting
Budapest, Hungary, 1145
Contact: Loránd Erőss, MD   
Principal Investigator: Loránd Erőss, MD         
University of Pécs Clinical Centre (PTE KK) Recruiting
Pécs, Hungary, 7624
Contact: József Janszky, Prof.   
Principal Investigator: József Janszky, MD         
AZ. Ospedaliero-Universitario-Ospedali Riuniti Recruiting
Ancona, Italy, 60020
Contact: Massimo Scerrati, Prof.    +39 071 596 4578   
Principal Investigator: Massimo Scerrati, MD         
AO Niguarda Ca' Granda Terminated
Milano, Italy, 20162
AO Santa Maria della Misericordia di Udine Recruiting
Udine, Italy, 33100
Contact: Roberto Eleopra, Dr.    0039 0432 554608   
Principal Investigator: Roberto Eleopra, MD         
SEIN Heemstede Recruiting
Heemstede, Netherlands, 2103
Contact: Jack Zwemmer, Dr.    31(0)23-5588940   
Principal Investigator: Jack Zwemmer, MD         
Expertisecentrum Voor Epileptologie-Kempenhaeghe Recruiting
Heeze, Netherlands, 65 5591 VE
Contact: Paul Boon, Prof.    (040) 227 90 22   
Principal Investigator: Paul Boon, MD         
SEIN Recruiting
Zwolle, Netherlands, 8025 BV
Contact: Jacqueline Ardesch, Dr.    (038) 8457185   
Principal Investigator: Jacqueline Ardesch, MD         
Sub-Investigator: Gerard Hageman, MD         
Szpital Uniwersytecki w Krakowie - Neurology Recruiting
Krakow, Poland, 31-503
Contact: Magdalena Bosak, Dr    0048-605-155 098   
Principal Investigator: Magdalena Bosak, MD         
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Recruiting
Lublin, Poland, 20-954
Contact: Jacek Gawlowicz, Dr.    81 537-42-29   
Principal Investigator: Jacek Gawlowicz, MD         
Hospital de Santa Maria Recruiting
Lisbon, Portugal, 1649-035
Contact: Antonio Gonçalves Ferreira, Prof.   
Principal Investigator: Antonio Gonçalves Ferreira, MD         
Centro Hospitalar de São João E.P.E. Recruiting
Porto, Portugal, 4200-319
Contact: Rui Vaz, Prof.   
Principal Investigator: Rui Vaz, MD         
Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Lisa Gordon, Dr.   
Principal Investigator: Lisa Gordon, MD         
Klinisk Neurovetenskap Recruiting
Umea, Sweden, SE-901 85
Contact: Patric Blomstedt, Prof.    +46907850000   
Principal Investigator: Patric Blomstedt, MD         
Uppsala Akademiska Hospital Recruiting
Uppsala, Sweden
Contact: Eva Kumlien, MD    +46 18-611 50 03   
Principal Investigator: Eva Kumlien, MD         
United Kingdom
University Hospitals Birmingham NHS Foundation Trust Not yet recruiting
Birmingham, United Kingdom, B15 2TH
Contact: Dougall McCorry, Dr   
Frenchay Hospital Recruiting
Bristol, United Kingdom, BS16 1LE
Contact: Nik Patel, Dr    +441173403953   
Principal Investigator: Howard Faulkner, MD         
Ninewells Hospital Withdrawn
Dundee, United Kingdom, DD1 9SY
Charing Cross Hospital Not yet recruiting
London, United Kingdom, W 8BE
Contact: Nicola Pavese, Dr.   
Royal Victoria Infirmary Not yet recruiting
Newcastle, United Kingdom, NE1 4LP
Contact: Yvonne Hart, Dr   
Royal Hallamshire Hospital Recruiting
Sheffield, United Kingdom, S10 2JF
Contact: Jeremy Rowe, Dr   
Sponsors and Collaborators
Medtronic International Trading Sarl
Principal Investigator: Paul Boon, MD Private
  More Information

No publications provided

Responsible Party: Medtronic International Trading Sarl 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 9, 2015
Health Authority: Austria: Ethikkommission
Finland: Ethics Committee
Germany: Ethics Commission
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Poland: Ethics Committee
Portugal: Ethics Committee for Clinical Research
Sweden: Regional Ethical Review Board
Spain: Ethics Committee
United Kingdom: Ethics Committee

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on October 08, 2015