Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Drug-Resistant Epilepsy in the MORE Multicenter Patient Registry
Jukka Peltola, Albert Colon, José Pimentel, Volker A. Coenen, António Gil‐Nagel, A Gonçalves-Ferreira, Kai Lehtimäki, Philippe Ryvlin, Rod S Taylor, Linda Ackermans, Jacqueline Ardesch, Carla Bentes, Magdalena Bosak, Jorge G. Burneo, Clara Chamadoira, Christian E. Elger, Lóránd Erőss, Dániel Fabó, Howard J. Faulkner, Jacek Gawłowicz, Alireza Gharabaghi, Maurizio Iacoangeli, József Janszky, Soila Järvenpää, Elisabeth Kaufmann, Kuan H. Kho, Eva Kumlien, Helmut Laufs, Christian Lettieri, Paulo Linhares, Soheyl Noachtar, Andrew G. Parrent, Ekaterina Pataraia, Nikunj Patel, Ana Rita Peralta, Áttila Rácz, Alexandre Rainha Campos, Ricardo Rego, Riccardo Antonio Ricciuti, Sabine Rona, Rob P.W. Rouhl, Andreas Schulze‐Bonhage, Rick Schuurman, Mathieu Sprengers, Albert Sufianov, Yasin Temel, Tom Theys, Wim Van Paesschen, Dirk Van Roost, Ruí Vaz, Kristl Vonck, Louis Wagner, Jack Zwemmer, Abdallah Abouihia, Thomas C. Brionne, Frans Gielen, Paul Boon, for The MORE Study Group, for The MORE Study Group, Isabel Amorim, Susanne Aull-Watschinger, István Balás, Beáta Bóné, Suzan Brown, Elisabetta Cesaroni, Evy Cleeren, Małgorzata Dec‐Ćwiek, Dr. Roberto Eleopra, Daniela Falk, Ana Franco, Birte Hackelberg, Kevin G. Hampel, Martin Hirsch, Johannes Konrad Meyne, Norbert Kovács, Nicolas Lang, Gabriel Möddel, Bettina Moeller, Massimo Mondani, Robert D. Nass, Klaus Novak, Katarzyna Obszańska, А. В. Орлов, Wojciech Pietraszko, Massimo Scerrati, А. Г. Шапкин, А. А. Скрипников, Anaïs Van Hoylandt, Bettina Viebahn, Sonja Wieszmuellner, Nelia Zamponi
Abstract
BACKGROUND AND OBJECTIVES: The efficacy of deep brain stimulation of the anterior nucleus of the thalamus (ANT DBS) in patients with drug-resistant epilepsy (DRE) was demonstrated in the double-blind Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy randomized controlled trial. The Medtronic Registry for Epilepsy (MORE) aims to understand the safety and longer-term effectiveness of ANT DBS therapy in routine clinical practice. METHODS: MORE is an observational registry collecting prospective and retrospective clinical data. Participants were at least 18 years old, with focal DRE recruited across 25 centers from 13 countries. They were followed for at least 2 years in terms of seizure frequency (SF), responder rate (RR), health-related quality of life (Quality of Life in Epilepsy Inventory 31), depression, and safety outcomes. RESULTS: < 0.0001) with 53.2% RR. High-volume centers (>10 implantations) had 42.8% reduction in median monthly SF by 2 years in comparison with 25.8% in low-volume center. In patients with cognitive impairment, the reduction in median monthly SF was 26.0% by 2 years compared with 36.1% in patients without cognitive impairment. The most frequently reported adverse events were changes (e.g., increased frequency/severity) in seizure (16%), memory impairment (patient-reported complaint, 15%), depressive mood (patient-reported complaint, 13%), and epilepsy (12%). One definite sudden unexpected death in epilepsy case was reported. DISCUSSION: The MORE registry supports the effectiveness and safety of ANT DBS therapy in a real-world setting in the 2 years following implantation. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that ANT DBS reduces the frequency of seizures in patients with drug-resistant focal epilepsy. TRIAL REGISTRATION INFORMATION: MORE ClinicalTrials.gov Identifier: NCT01521754, first posted on January 31, 2012.