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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01521754
Recruitment Status : Active, not recruiting
First Posted : January 31, 2012
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Brief Summary:
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 or disease
Refractory Epilepsy

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 191 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Medtronic Registry for Epilepsy (MORE)
Actual Study Start Date : March 6, 2012
Actual Primary Completion Date : June 19, 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort
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.



Primary Outcome Measures :
  1. Seizure rate [ Time Frame: Participants will be followed for the duration of the registry, an expected average of 3 years ]
    Evaluate the change in seizure rate from baseline over 2 years following DBS implant.


Secondary Outcome Measures :
  1. Seizure type and severity [ Time Frame: Participants will be followed for the duration of the registry, an expected average of 3 years ]
    To characterize seizure type and severity

  2. Depression score assessment [ Time Frame: Participants will be followed for the duration of the registry, an expected average of 3 years ]
    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

  3. Health Related Quality of Life (HRQoL) [ Time Frame: Participants will be followed for the duration of the registry, an expected average of 3 years ]
    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)

  4. Adverse Events characterization [ Time Frame: Participants will be followed for the duration of the registry, an expected average of 3 years ]
    To assess adverse events related to the device, implant procedure, and/or therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521754


Locations
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Austria
Medizinische Universität Wien
Vienna, Austria, 1090
Belgium
UZ Gent
Gent, Belgium, 9000
UZ K.U. Leuven
Leuven, Belgium, 3000
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, B110-118
Finland
University & Hospital of Tampere - Neurology and Rehabilitation
Tampere, Finland, 33521
Germany
Universitätsklinikum Bonn -AöR-
Bonn, Germany, 53105
University Hospital Freiburg
Freiburg, Germany, 79106
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Germany, 24105
Klinikum der Universität München -Großhadern
Munich, Germany, 81377
University Hospital Tübingen
Tübingen, Germany, 72076
Hungary
Országos Idegtudományi Intézet / National Institute of Neurosciences
Budapest, Hungary, 1145
University of Pécs Clinical Centre (PTE KK)
Pécs, Hungary, 7624
Italy
AZ. Ospedaliero-Universitario-Ospedali Riuniti
Ancona, Italy, 60020
AO Niguarda Ca' Granda
Milano, Italy, 20162
AO Santa Maria della Misericordia di Udine
Udine, Italy, 33100
Netherlands
SEIN Heemstede
Heemstede, Netherlands, 2103
Expertisecentrum Voor Epileptologie-Kempenhaeghe
Heeze, Netherlands, 65 5591 VE
SEIN
Zwolle, Netherlands, 8025 BV
Poland
Szpital Uniwersytecki w Krakowie - Neurology
Krakow, Poland, 31-503
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, Poland, 20-954
Portugal
Hospital de Santa Maria
Lisbon, Portugal, 1649-035
Centro Hospitalar de São João E.P.E.
Porto, Portugal, 4200-319
Russian Federation
Federal center of neurosurgery
Tyumen, Russian Federation, 625032
Saudi Arabia
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia, 12713
Sweden
Karolinska University Hospital
Stockholm, Sweden, 17176
Klinisk Neurovetenskap
Umea, Sweden, SE-901 85
Uppsala Akademiska Hospital
Uppsala, Sweden
United Kingdom
Frenchay Hospital
Bristol, United Kingdom, BS16 1LE
Sponsors and Collaborators
MedtronicNeuro
Investigators
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Principal Investigator: Paul Boon, MD Private

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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01521754    
Other Study ID Numbers: 1.02.9001
Addendum C.AD.1 ( Other Identifier: Addendum C.AD.1 )
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases