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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Medtronic International Trading Sarl
Sponsor:
Information provided by (Responsible Party):
Medtronic International Trading Sarl
ClinicalTrials.gov Identifier:
NCT01521754
First received: January 13, 2012
Last updated: June 23, 2016
Last verified: June 2016
  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
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: August 2020
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
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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  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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 ClinicalTrials.gov identifier: NCT01521754

Contacts
Contact: Ariane Beaumann +41 (0)21 803 8467 ariane.beaumann@medtronic.com
Contact: Gregory Beth gregory.beth@medtronic.com

  Show 34 Study Locations
Sponsors and Collaborators
Medtronic International Trading Sarl
Investigators
Principal Investigator: Paul Boon, MD Private
  More Information

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: June 23, 2016
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
United Kingdom: National Institute for Health Research
Canada: Ethics Review Committee
Russia: Ethics Committee
Belgium: Ethics Committee
Sweden: Central Ethical Review Board

Additional relevant MeSH terms:
Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 30, 2016