Product Surveillance Registry- Deep Brain Stimulation for Epilepsy

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)

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.