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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

Tracking Information
First Submitted Date January 13, 2012
First Posted Date January 31, 2012
Last Update Posted Date September 16, 2019
Actual Study Start Date March 6, 2012
Actual Primary Completion Date June 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 30, 2012)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01521754 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 30, 2012)
  • 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
  • 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
  • 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)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Product Surveillance Registry- Deep Brain Stimulation for Epilepsy
Official Title Medtronic Registry for Epilepsy (MORE)
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)
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults diagnosed with refractory epilepsy characterized by partial-onset seizures, with or without secondary generalization
Condition Refractory Epilepsy
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: June 19, 2018)
191
Original Estimated Enrollment
 (submitted: January 30, 2012)
200
Estimated Study Completion Date March 2020
Actual Primary Completion Date June 19, 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Belgium,   Canada,   Finland,   Germany,   Hungary,   Italy,   Netherlands,   Poland,   Portugal,   Russian Federation,   Saudi Arabia,   Sweden,   United Kingdom
Removed Location Countries Spain
 
Administrative Information
NCT Number NCT01521754
Other Study ID Numbers 1.02.9001
Addendum C.AD.1 ( Other Identifier: Addendum C.AD.1 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party MedtronicNeuro
Study Sponsor MedtronicNeuro
Collaborators Not Provided
Investigators
Principal Investigator: Paul Boon, MD Private
PRS Account MedtronicNeuro
Verification Date September 2019