Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Drug-Resistant Epilepsy in the MORE Multicenter Patient Registry. (2nd May 2023)

• Record Type: Journal Article
• Authors: Peltola, Jukka; Colon, Albert J.; Pimentel, José; Coenen, Volker A.; Gil-Nagel, Antonio; Gonçalves Ferreira, Antonio; Lehtimäki, Kai; Ryvlin, Philippe; Taylor, Rod S.; Ackermans, Linda; Ardesch, Jacqueline; Bentes, Carla; Bosak, Magdalena; Burneo, Jorge G.; Chamadoira, Clara; Elger, Christian E.; Erőss, Loránd; Fabo, Dániel; Faulkner, Howard; Gawlowicz, Jacek; Gharabaghi, Alireza; Iacoangeli, Maurizio; Janszky, Jozsef; Järvenpää, Soila; Kaufmann, Elisabeth; Kho, Kuan H.; Kumlien, Eva; Laufs, Helmut; Lettieri, Christian; Linhares, Paulo; Noachtar, Soheyl; Parrent, Andrew; Pataraia, Ekaterina; Patel, Nikunj K.; Peralta, Ana Rita; Rácz, Attila; Campos, Alexandre Rainha; Rego, Ricardo; Ricciuti, Riccardo A.; Rona, Sabine; Rouhl, Rob P.W.; Schulze-Bonhage, Andreas; Schuurman, Rick; Sprengers, Mathieu; Sufianov, Albert; Temel, Yasin; Theys, Tom; Van Paesschen, Wim; Van Roost, Dirk; Vaz, Rui; Vonck, Kristl; Wagner, Louis; Zwemmer, Jack; Abouihia, Abdallah; Brionne, Thomas C.; Gielen, Frans; Boon, Paul A.J.M.;
• Other Names: author non-byline.; Amorim Isabel author non-byline.; Aull-Watschinger Susanne author non-byline.; BALÁS István author non-byline.; BÓNÉ Beáta author non-byline.; Brown Suzan author non-byline.; Cesaroni Elisabetta author non-byline.; Cleeren Evy author non-byline.; Dec-Ćwiek Małgorzata author non-byline.; Eleopra Dr. Roberto author non-byline.; Falk Daniela author non-byline.; Franco Ana author non-byline.; Hackelberg Birte author non-byline.; Hampel Kevin author non-byline.; Hirsch Dr. Martin author non-byline.; Meyne Johannes Konrad author non-byline.; KOVÁCS Norbert author non-byline.; Lang Nicolas author non-byline.; Möddel Gabriel author non-byline.; Moeller Bettina author non-byline.; Mondani Dr. Massimo author non-byline.; Nass Robert D author non-byline.; Novak Klaus author non-byline.; Obszanska Dr. Katarzyna author non-byline.; Orlov Alexander author non-byline.; Pietraszko Wojciech author non-byline.; Scerrati Massimo author non-byline.; Shapkin Andrey author non-byline.; Skripnikov Alexander author non-byline.; Van Hoylandt Anais author non-byline.; Viebahn Bettina author non-byline.; Wieszmuellner Sonja author non-byline.; Zamponi Nelia author non-byline.;
• Is Part Of: Neurology. Volume 100:Number 18(2023)
• Page Start: e1852
• Page End: e1865
• Publication Date: 2023-05-02
• Subjects: Neurology -- Periodicals; Neurology -- Periodicals; Neurologie -- Périodiques; 616.8
• DOI: 10.1212/WNL.0000000000206887
• Languages: English
• ISSNs: 0028-3878

Abstract

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: Of the 191 patients recruited, 170 (mean [SD] age of 35.6 [10.7] years, 43% female) were implanted with DBS therapy and met all eligibility criteria. At baseline, 38% of patients reported cognitive impairment. The median monthly SF decreased by 33.1% from 15.8 at baseline to 8.8 at 2 years ( p < 0.0001) with 32.3% RR. In the subgroup of 47 patients who completed 5 years of follow-up, the median monthly SF decreased by 55.1% from 16 at baseline to 7.9 at 5 years ( p < 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.