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

Medtronic Registry for Epilepsy (MORE)

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.

Study Overview

• Status: Completed
• Conditions: Refractory Epilepsy

Detailed Description

Introduction

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.

Enrollment and Duration Patients meeting the eligibility criteria for the implantation of the Medtronic® DBS™ Therapy for Epilepsy will be included in the registry. Approximately 200 patients meeting all the eligibility criteria will be prospectively enrolled over an expected two-year period.

Approximately 30 centers, mainly from across Europe will participate. Center selection could also be extended to sites outside Europe.

Each patient will perform follow-up visits according to clinical practice.

The estimated duration of the registry will be approximately 49 months (24 months for the enrollment phase, 24 months for follow-up visits and 1 month for final data collection).

Inclusion and exclusion 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.

Registry Procedures

After the physician has determined that a patient meets all of the eligibility criteria, the physician will enroll the patient in the registry by completing the Patient Informed Consent or Data Release Consent Form process.

Once enrolled, patients will be followed at least for 24 months or until their discontinuation from the registry.

Follow-up visits will occur according to clinical practice, approximately every 6 months after the first visit post-implant.

Adverse events and/or device events will be reported as they occur.

Data collection will occur at the following time points:

• Enrollment Visit
• Baseline Visit
• Implant Visit
• Follow-up Visits (over a period of minimum two years)

The following follow-up visits are scheduled according to the clinical practice, approximately every 6 months for at least two years or till the closure of the registry.

Primary Objective The primary efficacy objective is to evaluate the change in seizure rate from baseline over 2 years following DBS implant.

Secondary Objectives

• To characterize the demographics of the population undergoing Medtronic® DBS™ Therapy for Epilepsy,
• To assess adverse events related to the device, implant procedure, and/or therapy.
• To characterize seizure type and severity.
• To characterize co-treatments.
• 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).
• To evaluate changes in depression score over time Exploratory objectives
• To assess use of health care resources specifically associated with epilepsy following DBS.
• To characterize DBS implant technique and device/feature utilization.
• To assess the factors that better predict the response level of the DBS therapy.

Sample Size Justification The purpose of the registry is essentially observational and exploratory; hence no sample size calculation was performed.

Safety objectives

• To assess adverse events
• To characterize the incidence of sudden unexpected death in epilepsy (SUDEP)

• Study Type: Observational
• Enrollment (Actual): 191

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults diagnosed with refractory epilepsy characterized by partial-onset seizures, with or without secondary generalization

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure type and severity	To characterize seizure type and severity	Participants will be followed for the duration of the registry, an expected average of 3 years
Depression score assessment	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	Participants will be followed for the duration of the registry, an expected average of 3 years
Health Related Quality of Life (HRQoL)	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)	Participants will be followed for the duration of the registry, an expected average of 3 years
Adverse Events characterization	To assess adverse events related to the device, implant procedure, and/or therapy.	Participants will be followed for the duration of the registry, an expected average of 3 years

Collaborators and Investigators

• Sponsor: MedtronicNeuro
• Investigators: Principal Investigator: Paul Boon, MD, Private

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2012
• Primary Completion (Actual): June 19, 2019
• Study Completion (Actual): June 19, 2019

Study Registration Dates

• First Submitted: January 13, 2012
• First Submitted That Met QC Criteria: January 30, 2012
• First Posted (Estimate): January 31, 2012

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: 1.02.9001; Addendum C.AD.1 (Other Identifier: Addendum C.AD.1)