Product Surveillance Registry- Deep Brain Stimulation for Epilepsy

NCT01521754 | Completed DMC

• 2 other identifiers: 1.02.9001Addendum C.AD.1
• Study Type: observational
• Target: 191
• Locations: 13 countries
• Sites: 27

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.

Conditions

Refractory Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Seizure type and severity

  Participants will be followed for the duration of the registry, an expected average of 3 years

• Depression score assessment

  Participants will be followed for the duration of the registry, an expected average of 3 years

• Health Related Quality of Life (HRQoL)

  Participants will be followed for the duration of the registry, an expected average of 3 years

• Adverse Events characterization

  Participants will be followed for the duration of the registry, an expected average of 3 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (27)

Medizinische Universität Wien

Vienna, 1090, Austria

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ K.U. Leuven

Leuven, 3000, Belgium

Location

London Health Sciences Centre

London, Ontario, B110-118, Canada

Location

University & Hospital of Tampere - Neurology and Rehabilitation

Tampere, 33521, Finland

Location

Universitätsklinikum Bonn -AöR-

Bonn, 53105, Germany

Location

University Hospital Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

Klinikum der Universität München -Großhadern

Munich, 81377, Germany

Location

University Hospital Tübingen

Tübingen, 72076, Germany

Location

Országos Idegtudományi Intézet / National Institute of Neurosciences

Budapest, 1145, Hungary

Location

University of Pécs Clinical Centre (PTE KK)

Pécs, 7624, Hungary

Location

AZ. Ospedaliero-Universitario-Ospedali Riuniti

Ancona, 60020, Italy

Location

AO Niguarda Ca' Granda

Milan, 20162, Italy

Location

AO Santa Maria della Misericordia di Udine

Udine, 33100, Italy

Location

SEIN Heemstede

Heemstede, 2103, Netherlands

Location

Expertisecentrum Voor Epileptologie-Kempenhaeghe

Heeze, 65 5591 VE, Netherlands

Location

SEIN

Zwolle, 8025 BV, Netherlands

Location

Szpital Uniwersytecki w Krakowie - Neurology

Krakow, 31-503, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Lublin, 20-954, Poland

Location

Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Centro Hospitalar de São João E.P.E.

Porto, 4200-319, Portugal

Location

Federal center of neurosurgery

Tyumen, 625032, Russia

Location

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Klinisk Neurovetenskap

Umeå, SE-901 85, Sweden

Location

Uppsala Akademiska Hospital

Uppsala, Sweden

Location

Frenchay Hospital

Bristol, BS16 1LE, United Kingdom

Location

Related Publications (1)

• Peltola J, Colon AJ, Pimentel J, Coenen VA, Gil-Nagel A, Goncalves Ferreira A, Lehtimaki K, Ryvlin P, Taylor RS, Ackermans L, Ardesch J, Bentes C, Bosak M, Burneo JG, Chamadoira C, Elger CE, Eross L, Fabo D, Faulkner H, Gawlowicz J, Gharabaghi A, Iacoangeli M, Janszky J, Jarvenpaa S, Kaufmann E, Kho KH, Kumlien E, Laufs H, Lettieri C, Linhares P, Noachtar S, Parrent A, Pataraia E, Patel NK, Peralta AR, Racz A, Campos AR, Rego R, Ricciuti RA, Rona S, Rouhl RPW, Schulze-Bonhage A, Schuurman R, Sprengers M, Sufianov A, Temel Y, Theys T, Van Paesschen W, Van Roost D, Vaz R, Vonck K, Wagner L, Zwemmer J, Abouihia A, Brionne TC, Gielen F, Boon PAJM; MORE Study Group. Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Drug-Resistant Epilepsy in the MORE Multicenter Patient Registry. Neurology. 2023 May 2;100(18):e1852-e1865. doi: 10.1212/WNL.0000000000206887. Epub 2023 Mar 16.

  PMID: 36927882 DERIVED

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Paul Boon, MD

  Private

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 31, 2012
• Study Start: March 6, 2012
• Primary Completion: June 19, 2019
• Study Completion: June 19, 2019
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

PL (2); RU (1); DE (5); IT (3); HU (2); PT (2); GB (1); FI (1); BE (2); SE (3); NL (3); AU (1); CA (1)