Product Surveillance Registry- Deep Brain Stimulation for Epilepsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Medtronic Registry for Epilepsy (MORE)

Conditions
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Refractory Epilepsy

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Perspective<br>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<br>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?
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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 |