Clinical trial NCT01521754: Product Surveillance Registry- Deep Brain Stimulation for Epilepsy
Official title: Medtronic Registry for Epilepsy (MORE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractory Epilepsy
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2012-01-31
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults diagnosed with refractory epilepsy characterized by partial-onset seizures, with or without secondary generalization

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.

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)

Eligibility 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.

Primary outcomes:
measure: Seizure rate
timeFrame: Participants will be followed for the duration of the registry, an expected average of 3 years
Secondary outcomes:
measure: Seizure type and severity
timeFrame: Participants will be followed for the duration of the registry, an expected average of 3 years
measure: Depression score assessment
timeFrame: Participants will be followed for the duration of the registry, an expected average of 3 years
measure: Health Related Quality of Life (HRQoL)
timeFrame: Participants will be followed for the duration of the registry, an expected average of 3 years
measure: Adverse Events characterization
timeFrame: Participants will be followed for the duration of the registry, an expected average of 3 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medizinische Universität Wien
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ K.U. Leuven
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Tampere
country: Finland
facility: University & Hospital of Tampere - Neurology and Rehabilitation
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn -AöR-
city: Freiburg
country: Germany
facility: University Hospital Freiburg
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel
city: Munich
country: Germany
facility: Klinikum der Universität München -Großhadern
city: Tübingen
country: Germany
facility: University Hospital Tübingen
city: Budapest
country: Hungary
facility: Országos Idegtudományi Intézet / National Institute of Neurosciences
city: Pécs
country: Hungary
facility: University of Pécs Clinical Centre (PTE KK)
city: Ancona
country: Italy
facility: AZ. Ospedaliero-Universitario-Ospedali Riuniti
city: Milano
country: Italy
facility: AO Niguarda Ca' Granda
city: Udine
country: Italy
facility: AO Santa Maria della Misericordia di Udine
city: Heemstede
country: Netherlands
facility: SEIN Heemstede
city: Heeze
country: Netherlands
facility: Expertisecentrum Voor Epileptologie-Kempenhaeghe
city: Zwolle
country: Netherlands
facility: SEIN
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie - Neurology
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
city: Lisbon
country: Portugal
facility: Hospital de Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar de São João E.P.E.
city: Tyumen
country: Russian Federation
facility: Federal center of neurosurgery
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Umea
country: Sweden
facility: Klinisk Neurovetenskap
city: Uppsala
country: Sweden
facility: Uppsala Akademiska Hospital
city: Bristol
country: United Kingdom
facility: Frenchay Hospital
Study officials:
affiliation: Private
name: Paul Boon, MD
role: PRINCIPAL_INVESTIGATOR
References: