Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Drug-Resistant Epilepsy in the MORE Multicenter Patient Registry

Jukka Peltola; Albert J. Colon; José Pimentel; Volker A. Coenen; Antonio Gil-Nagel; Antonio 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; Loránd Erőss; D. niel Fabo; Howard Faulkner; Jacek Gawlowicz; Alireza Gharabaghi; Maurizio Iacoangeli; Jozsef Janszky; Soila Järvenpää; Elisabeth Kaufmann; Kuan H. Kho; Eva Kumlien; Helmut Laufs; Christian Lettieri; Paulo Linhares; Soheyl Noachtar; Andrew Parrent; Ekaterina Pataraia; Nikunj K. Patel; Ana Rita Peralta; Attila Rácz; Alexandre Rainha Campos; Ricardo Rego; Riccardo A. 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; Rui Vaz; Kristl Vonck; Louis Wagner; Jack Zwemmer; Abdallah Abouihia; Thomas C. Brionne; Frans Gielen; Paul A. J. M. Boon; Isabel Amorim; Susanne Aull-Watschinger; István Balás; Beáta Bóné; Suzan Brown; Elisabetta Cesaroni; Evy Cleeren; Małgorzata Dec-Ćwiek; Roberto Eleopra; Daniela Falk; Ana Franco; Birte Hackelberg; Kevin Hampel; Martin Hirsch; Johannes Konrad Meyne; Norbert Kovács; Nicolas Lang; Gabriel Möddel; Bettina Moeller; Massimo Mondani; Robert D. Nass; Klaus Novak; Katarzyna Obszanska; Alexander Orlov; Wojciech Pietraszko; Massimo Scerrati; Andrey Shapkin; Alexander Skripnikov; Anais van Hoylandt; Bettina Viebahn; Sonja Wieszmuellner; Nelia Zamponi

doi:https://doi.org/10.1212/WNL.0000000000206887

Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Drug-Resistant Epilepsy in the MORE Multicenter Patient Registry

Jukka Peltola, Albert J. Colon, José Pimentel, Volker A. Coenen, Antonio Gil-Nagel, Antonio 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, Loránd Erőss, D. niel Fabo, Howard Faulkner, Jacek GawlowiczAlireza Gharabaghi, Maurizio Iacoangeli, Jozsef Janszky, Soila Järvenpää, Elisabeth Kaufmann, Kuan H. Kho, Eva Kumlien, Helmut Laufs, Christian Lettieri, Paulo Linhares, Soheyl Noachtar, Andrew Parrent, Ekaterina Pataraia, Nikunj K. Patel, Ana Rita Peralta, Attila Rácz, Alexandre Rainha Campos, Ricardo Rego, Riccardo A. 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, Rui Vaz, Kristl Vonck, Louis Wagner, Jack Zwemmer, Abdallah Abouihia, Thomas C. Brionne, Frans Gielen, Paul A. J. M. Boon, Isabel Amorim, Susanne Aull-Watschinger, István Balás, Beáta Bóné, Suzan Brown, Elisabetta Cesaroni, Evy Cleeren, Małgorzata Dec-Ćwiek, Roberto Eleopra, Daniela Falk, Ana Franco, Birte Hackelberg, Kevin Hampel, Martin Hirsch, Johannes Konrad Meyne, Norbert Kovács, Nicolas Lang, Gabriel Möddel, Bettina Moeller, Massimo Mondani, Robert D. Nass, Klaus Novak, Katarzyna Obszanska, Alexander Orlov, Wojciech Pietraszko, Massimo Scerrati, Andrey Shapkin, Alexander Skripnikov, Anais van Hoylandt, Bettina Viebahn, Sonja Wieszmuellner, Nelia Zamponi

Research output: Contribution to journal › Article › Academic › peer-review

12 Citations (Scopus)

Abstract

Background and ObjectivesThe 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.MethodsMORE 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.ResultsOf 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.DiscussionThe MORE registry supports the effectiveness and safety of ANT DBS therapy in a real-world setting in the 2 years following implantation.Classification of EvidenceThis study provides Class IV evidence that ANT DBS reduces the frequency of seizures in patients with drug-resistant focal epilepsy.

Original language	English
Pages (from-to)	E1852-E1865
Journal	Neurology
Volume	100
Issue number	18
DOIs	https://doi.org/10.1212/WNL.0000000000206887
Publication status	Published - 2 May 2023

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https://doi.org/10.1212/WNL.0000000000206887

Cite this

Peltola, J., Colon, A. J., Pimentel, J., Coenen, V. A., Gil-Nagel, A., Ferreira, A. G., Lehtimäki, K., Ryvlin, P., Taylor, R. S., Ackermans, L., Ardesch, J., Bentes, C., Bosak, M., Burneo, J. G., Chamadoira, C., Elger, C. E., Erőss, L., Fabo, D. N., Faulkner, H., ... Zamponi, N. (2023). Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Drug-Resistant Epilepsy in the MORE Multicenter Patient Registry. Neurology, 100(18), E1852-E1865. https://doi.org/10.1212/WNL.0000000000206887

@article{1cac1d731e484126a797410bb4a70002,

title = "Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Drug-Resistant Epilepsy in the MORE Multicenter Patient Registry",

abstract = "Background and ObjectivesThe 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.MethodsMORE 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.ResultsOf 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.DiscussionThe MORE registry supports the effectiveness and safety of ANT DBS therapy in a real-world setting in the 2 years following implantation.Classification of EvidenceThis study provides Class IV evidence that ANT DBS reduces the frequency of seizures in patients with drug-resistant focal epilepsy.",

author = "Jukka Peltola and Colon, {Albert J.} and Jos{\'e} Pimentel and Coenen, {Volker A.} and Antonio Gil-Nagel and Ferreira, {Antonio Gon{\c c}alves} and Kai Lehtim{\"a}ki and Philippe Ryvlin and Taylor, {Rod S.} and Linda Ackermans and Jacqueline Ardesch and Carla Bentes and Magdalena Bosak and Burneo, {Jorge G.} and Clara Chamadoira and Elger, {Christian E.} and Lor{\'a}nd Er{\H o}ss and Fabo, {D. niel} and Howard Faulkner and Jacek Gawlowicz and Alireza Gharabaghi and Maurizio Iacoangeli and Jozsef Janszky and Soila J{\"a}rvenp{\"a}{\"a} and Elisabeth Kaufmann and Kho, {Kuan H.} and Eva Kumlien and Helmut Laufs and Christian Lettieri and Paulo Linhares and Soheyl Noachtar and Andrew Parrent and Ekaterina Pataraia and Patel, {Nikunj K.} and Peralta, {Ana Rita} and Attila R{\'a}cz and Campos, {Alexandre Rainha} and Ricardo Rego and Ricciuti, {Riccardo A.} and Sabine Rona and Rouhl, {Rob P. W.} and Andreas Schulze-Bonhage and Rick Schuurman and Mathieu Sprengers and Albert Sufianov and Yasin Temel and Tom Theys and {van Paesschen}, Wim and {van Roost}, Dirk and Rui Vaz and Kristl Vonck and Louis Wagner and Jack Zwemmer and Abdallah Abouihia and Brionne, {Thomas C.} and Frans Gielen and Boon, {Paul A. J. M.} and Isabel Amorim and Susanne Aull-Watschinger and Istv{\'a}n Bal{\'a}s and Be{\'a}ta B{\'o}n{\'e} and Suzan Brown and Elisabetta Cesaroni and Evy Cleeren and Ma{\l}gorzata Dec-{\'C}wiek and Roberto Eleopra and Daniela Falk and Ana Franco and Birte Hackelberg and Kevin Hampel and Martin Hirsch and Meyne, {Johannes Konrad} and Norbert Kov{\'a}cs and Nicolas Lang and Gabriel M{\"o}ddel and Bettina Moeller and Massimo Mondani and Nass, {Robert D.} and Klaus Novak and Katarzyna Obszanska and Alexander Orlov and Wojciech Pietraszko and Massimo Scerrati and Andrey Shapkin and Alexander Skripnikov and {van Hoylandt}, Anais and Bettina Viebahn and Sonja Wieszmuellner and Nelia Zamponi",

note = "Funding Information: The Article Processing Charge was funded by Medtronic. Funding Information: J. Peltola has participated in clinical trials for Eisai, UCB, and Bial; received research grants from Eisai, Medtronic, UCB, and Livanova; received speaker honoraria from LivaNova, Eisai, Medtronic, Orion Pharma, and UCB; received support for travel to congresses from LivaNova, Eisai, Medtronic, and UCB; and participated in advisory boards for Arvelle, Novartis, LivaNova, Eisai, Medtronic, UCB, and GW Pharma. A.J. Colon received speaker honoraria from Medtronic. J. Pimentel received occasionally fees from Medtronic for speeches, travel meetings and collecting data for the MORE registry, and courses. V.A. Coenen received honoraria for talks from Boston Scientific, USA. He has received grants for clinical trials (IITs) from Boston Scientific, USA, and Medtronic, USA. He receives an ongoing collaborative grant from BrainLab (Munich, Germany). V.A. Coenen is scientific advisor for CereGate (Hamburg) and Cortec (Freiburg). A. Gil-Nagel received grants or honoraria as speaker or advisory board from Bial, Biocodex, Eisai, Stoke Therapeutics, GW Pharma, Esteve, UCB Pharma, Zogenix, and Arvelle Therapeutics. A. Gon{\c c}alves Ferreira declares Medtronic support to his participation in different scientific events including being member of the MORE Steering Committee. K. Lehtim{\"a}ki received speaker or consultancy fees from Medtronic. P. Ryvlin has received speaker or consultant fees from UCB Pharma, GW Pharmaceutical, Eisai, Arvelle, Livanova, and Medtronic. R.S. Taylor is a paid consultant for Medtronic. However, he received no payment associated with preparation/contribution to this manuscript. L. Ackermans reports no disclosures relevant to the manuscript. J. Ardesch reports no disclosures relevant to the manuscript; she is a member of a data safety monitoring board, nonprofit. C. Bentes reports that the Reference Centre for Refractory Epilepsy from Hospital de Santa Maria {\^A}–Centro Hospitalar Lisboa Norte received fees from Medtronic in January 2021 for the educational course: Curso Luso Brasileiro DBS em Epilepsia. M. Bosak received honoraria for publications for and participation in advisory meetings from Sanofi, honoraria for lectures, travel expenses, and conference fees from Sanofi, Adamed, Teva Pharmaceutical, Neuraxpharm, Glenmark, UCB Pharma, and Zentiva. J.G. Burneo is the Jack Cowin endowed chair in Epilepsy Research at Western University. C. Chamadoira, C.E. Elger, L. Er{\H o}ss, D. Fabo, H. Faulkner, J. Gawlowicz, A. Gharabaghi, and M. Iacoangeli report no disclosures relevant to the manuscript. J. Janszky received consultation fees from Hungarian subsidiaries of UCB, Richter, and Gerot. Regarding this study, the author did not receive any corporate funding and receives research support from the Hungarian Brain Research Program (2017-1.2.1-NKP-2017-00002), NKFIH EFOP-3.6.2-16-2017-00008 government-based funds. S. J{\"a}rvenp{\"a}{\"a} received study grants from the Maire Taponen Foundation, Finnish Epilepsy Research Foundation, Finnish Medical Foundation, and Instrumentarium Science Foundation, none of which are relevant to the manuscript. E. Kaufmann has received speaker honoraria from Medtronic. K.H. Kho, E. Kumlien, H. Laufs, C. Lettieri, P. Linhares, S. Noachtar, A. Parrent, and E. Pataraia report no disclosures relevant to the manuscript. N.K. Patel reports no disclosures relevant to the manuscript. He is clinical director at Bioinduction Ltd. A.R. Peralta reports that Centro de Refer{\^e}ncia de Epilepsia Refract{\'a}ria, of which A.R. Peralta is a member, received speaker honoraria from Medtronic. A. R{\'a}cz received fees as a speaker from UCB Pharma. A. Rainha Campos received a travel grant and speaker honorarium from Medtronic. R. Rego received advisory honoraria from Medtronic. R.A. Ricciuti reports no disclosures relevant to the manuscript. S. Rona discloses compensation for data collection in the MORE study. R.P.W. Rouhl reports no disclosures relevant to the manuscript. A. Schulze-Bonhage has received research funding from BIAL, BMBF, DFG, EU, NIH, Precisis, and UNEEG. He has received honoraria for advice or lectures from Arvelle, BIAL, EISAI, GW, and UCB. R. Schuurman acts as consultant for Medtronic on educational matters. M. Sprengers, A. Sufianov, and Y. Temel report no disclosures relevant to the manuscript. T. Theys holds a learning chair Neuromodulation, an endowment from Medtronic. W. Van Paesschen, D. Van Roost, and R. Vaz report no disclosures relevant to the manuscript. K. Vonck has been funded by the Bijzonder Onderzoeksfonds (BOF) of Ghent University and received funding from the Geneeskundige Stichting Koningin Elisabeth (GSKE) for Neuroscience. K. Vonckt is also a consultant for Synergia Medical and Livanova and has received free devices for research studies in normal volunteers and preclinical studies from Cerbomed. L. Wagner and J. Zwemmer report no disclosures relevant to the manuscript. A. Abouihia was a Medtronic Employee at the time of performing the analyses and development of the manuscript. T.C. Brionne is a Medtronic Employee. F. Gielen is a Medtronic Employee. P.A.J.M. Boon received speaker and consultancy fees from LivaNova, Medtronic, UCB Pharma, and Eisai. Go to Neurology.org/N for full disclosures. Publisher Copyright: {\textcopyright} American Academy of Neurology.",

year = "2023",

month = may,

day = "2",

doi = "https://doi.org/10.1212/WNL.0000000000206887",

language = "English",

volume = "100",

pages = "E1852--E1865",

journal = "Neurology",

issn = "0028-3878",

publisher = "American Academy of Neurology",

number = "18",

}

Peltola, J, Colon, AJ, Pimentel, J, Coenen, VA, Gil-Nagel, A, Ferreira, AG, Lehtimäki, K, Ryvlin, P, Taylor, RS, Ackermans, L, Ardesch, J, Bentes, C, Bosak, M, Burneo, JG, Chamadoira, C, Elger, CE, Erőss, L, Fabo, DN, Faulkner, H, Gawlowicz, J, Gharabaghi, A, Iacoangeli, M, Janszky, J, Järvenpää, S, Kaufmann, E, Kho, KH, Kumlien, E, Laufs, H, Lettieri, C, Linhares, P, Noachtar, S, Parrent, A, Pataraia, E, Patel, NK, Peralta, AR, Rácz, 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, Amorim, I, Aull-Watschinger, S, Balás, I, Bóné, B, Brown, S, Cesaroni, E, Cleeren, E, Dec-Ćwiek, M, Eleopra, R, Falk, D, Franco, A, Hackelberg, B, Hampel, K, Hirsch, M, Meyne, JK, Kovács, N, Lang, N, Möddel, G, Moeller, B, Mondani, M, Nass, RD, Novak, K, Obszanska, K, Orlov, A, Pietraszko, W, Scerrati, M, Shapkin, A, Skripnikov, A, van Hoylandt, A, Viebahn, B, Wieszmuellner, S & Zamponi, N 2023, 'Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Drug-Resistant Epilepsy in the MORE Multicenter Patient Registry', Neurology, vol. 100, no. 18, pp. E1852-E1865. https://doi.org/10.1212/WNL.0000000000206887

TY - JOUR

T1 - Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Drug-Resistant Epilepsy in the MORE Multicenter Patient Registry

AU - Peltola, Jukka

AU - Colon, Albert J.

AU - Pimentel, José

AU - Coenen, Volker A.

AU - Gil-Nagel, Antonio

AU - Ferreira, Antonio Gonçalves

AU - Lehtimäki, Kai

AU - Ryvlin, Philippe

AU - Taylor, Rod S.

AU - Ackermans, Linda

AU - Ardesch, Jacqueline

AU - Bentes, Carla

AU - Bosak, Magdalena

AU - Burneo, Jorge G.

AU - Chamadoira, Clara

AU - Elger, Christian E.

AU - Erőss, Loránd

AU - Fabo, D. niel

AU - Faulkner, Howard

AU - Gawlowicz, Jacek

AU - Gharabaghi, Alireza

AU - Iacoangeli, Maurizio

AU - Janszky, Jozsef

AU - Järvenpää, Soila

AU - Kaufmann, Elisabeth

AU - Kho, Kuan H.

AU - Kumlien, Eva

AU - Laufs, Helmut

AU - Lettieri, Christian

AU - Linhares, Paulo

AU - Noachtar, Soheyl

AU - Parrent, Andrew

AU - Pataraia, Ekaterina

AU - Patel, Nikunj K.

AU - Peralta, Ana Rita

AU - Rácz, Attila

AU - Campos, Alexandre Rainha

AU - Rego, Ricardo

AU - Ricciuti, Riccardo A.

AU - Rona, Sabine

AU - Rouhl, Rob P. W.

AU - Schulze-Bonhage, Andreas

AU - Schuurman, Rick

AU - Sprengers, Mathieu

AU - Sufianov, Albert

AU - Temel, Yasin

AU - Theys, Tom

AU - van Paesschen, Wim

AU - van Roost, Dirk

AU - Vaz, Rui

AU - Vonck, Kristl

AU - Wagner, Louis

AU - Zwemmer, Jack

AU - Abouihia, Abdallah

AU - Brionne, Thomas C.

AU - Gielen, Frans

AU - Boon, Paul A. J. M.

AU - Amorim, Isabel

AU - Aull-Watschinger, Susanne

AU - Balás, István

AU - Bóné, Beáta

AU - Brown, Suzan

AU - Cesaroni, Elisabetta

AU - Cleeren, Evy

AU - Dec-Ćwiek, Małgorzata

AU - Eleopra, Roberto

AU - Falk, Daniela

AU - Franco, Ana

AU - Hackelberg, Birte

AU - Hampel, Kevin

AU - Hirsch, Martin

AU - Meyne, Johannes Konrad

AU - Kovács, Norbert

AU - Lang, Nicolas

AU - Möddel, Gabriel

AU - Moeller, Bettina

AU - Mondani, Massimo

AU - Nass, Robert D.

AU - Novak, Klaus

AU - Obszanska, Katarzyna

AU - Orlov, Alexander

AU - Pietraszko, Wojciech

AU - Scerrati, Massimo

AU - Shapkin, Andrey

AU - Skripnikov, Alexander

AU - van Hoylandt, Anais

AU - Viebahn, Bettina

AU - Wieszmuellner, Sonja

AU - Zamponi, Nelia

N1 - Funding Information: The Article Processing Charge was funded by Medtronic. Funding Information: J. Peltola has participated in clinical trials for Eisai, UCB, and Bial; received research grants from Eisai, Medtronic, UCB, and Livanova; received speaker honoraria from LivaNova, Eisai, Medtronic, Orion Pharma, and UCB; received support for travel to congresses from LivaNova, Eisai, Medtronic, and UCB; and participated in advisory boards for Arvelle, Novartis, LivaNova, Eisai, Medtronic, UCB, and GW Pharma. A.J. Colon received speaker honoraria from Medtronic. J. Pimentel received occasionally fees from Medtronic for speeches, travel meetings and collecting data for the MORE registry, and courses. V.A. Coenen received honoraria for talks from Boston Scientific, USA. He has received grants for clinical trials (IITs) from Boston Scientific, USA, and Medtronic, USA. He receives an ongoing collaborative grant from BrainLab (Munich, Germany). V.A. Coenen is scientific advisor for CereGate (Hamburg) and Cortec (Freiburg). A. Gil-Nagel received grants or honoraria as speaker or advisory board from Bial, Biocodex, Eisai, Stoke Therapeutics, GW Pharma, Esteve, UCB Pharma, Zogenix, and Arvelle Therapeutics. A. Gonçalves Ferreira declares Medtronic support to his participation in different scientific events including being member of the MORE Steering Committee. K. Lehtimäki received speaker or consultancy fees from Medtronic. P. Ryvlin has received speaker or consultant fees from UCB Pharma, GW Pharmaceutical, Eisai, Arvelle, Livanova, and Medtronic. R.S. Taylor is a paid consultant for Medtronic. However, he received no payment associated with preparation/contribution to this manuscript. L. Ackermans reports no disclosures relevant to the manuscript. J. Ardesch reports no disclosures relevant to the manuscript; she is a member of a data safety monitoring board, nonprofit. C. Bentes reports that the Reference Centre for Refractory Epilepsy from Hospital de Santa Maria Â–Centro Hospitalar Lisboa Norte received fees from Medtronic in January 2021 for the educational course: Curso Luso Brasileiro DBS em Epilepsia. M. Bosak received honoraria for publications for and participation in advisory meetings from Sanofi, honoraria for lectures, travel expenses, and conference fees from Sanofi, Adamed, Teva Pharmaceutical, Neuraxpharm, Glenmark, UCB Pharma, and Zentiva. J.G. Burneo is the Jack Cowin endowed chair in Epilepsy Research at Western University. C. Chamadoira, C.E. Elger, L. Erőss, D. Fabo, H. Faulkner, J. Gawlowicz, A. Gharabaghi, and M. Iacoangeli report no disclosures relevant to the manuscript. J. Janszky received consultation fees from Hungarian subsidiaries of UCB, Richter, and Gerot. Regarding this study, the author did not receive any corporate funding and receives research support from the Hungarian Brain Research Program (2017-1.2.1-NKP-2017-00002), NKFIH EFOP-3.6.2-16-2017-00008 government-based funds. S. Järvenpää received study grants from the Maire Taponen Foundation, Finnish Epilepsy Research Foundation, Finnish Medical Foundation, and Instrumentarium Science Foundation, none of which are relevant to the manuscript. E. Kaufmann has received speaker honoraria from Medtronic. K.H. Kho, E. Kumlien, H. Laufs, C. Lettieri, P. Linhares, S. Noachtar, A. Parrent, and E. Pataraia report no disclosures relevant to the manuscript. N.K. Patel reports no disclosures relevant to the manuscript. He is clinical director at Bioinduction Ltd. A.R. Peralta reports that Centro de Referência de Epilepsia Refractária, of which A.R. Peralta is a member, received speaker honoraria from Medtronic. A. Rácz received fees as a speaker from UCB Pharma. A. Rainha Campos received a travel grant and speaker honorarium from Medtronic. R. Rego received advisory honoraria from Medtronic. R.A. Ricciuti reports no disclosures relevant to the manuscript. S. Rona discloses compensation for data collection in the MORE study. R.P.W. Rouhl reports no disclosures relevant to the manuscript. A. Schulze-Bonhage has received research funding from BIAL, BMBF, DFG, EU, NIH, Precisis, and UNEEG. He has received honoraria for advice or lectures from Arvelle, BIAL, EISAI, GW, and UCB. R. Schuurman acts as consultant for Medtronic on educational matters. M. Sprengers, A. Sufianov, and Y. Temel report no disclosures relevant to the manuscript. T. Theys holds a learning chair Neuromodulation, an endowment from Medtronic. W. Van Paesschen, D. Van Roost, and R. Vaz report no disclosures relevant to the manuscript. K. Vonck has been funded by the Bijzonder Onderzoeksfonds (BOF) of Ghent University and received funding from the Geneeskundige Stichting Koningin Elisabeth (GSKE) for Neuroscience. K. Vonckt is also a consultant for Synergia Medical and Livanova and has received free devices for research studies in normal volunteers and preclinical studies from Cerbomed. L. Wagner and J. Zwemmer report no disclosures relevant to the manuscript. A. Abouihia was a Medtronic Employee at the time of performing the analyses and development of the manuscript. T.C. Brionne is a Medtronic Employee. F. Gielen is a Medtronic Employee. P.A.J.M. Boon received speaker and consultancy fees from LivaNova, Medtronic, UCB Pharma, and Eisai. Go to Neurology.org/N for full disclosures. Publisher Copyright: © American Academy of Neurology.

PY - 2023/5/2

Y1 - 2023/5/2

N2 - Background and ObjectivesThe 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.MethodsMORE 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.ResultsOf 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.DiscussionThe MORE registry supports the effectiveness and safety of ANT DBS therapy in a real-world setting in the 2 years following implantation.Classification of EvidenceThis study provides Class IV evidence that ANT DBS reduces the frequency of seizures in patients with drug-resistant focal epilepsy.

AB - Background and ObjectivesThe 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.MethodsMORE 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.ResultsOf 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.DiscussionThe MORE registry supports the effectiveness and safety of ANT DBS therapy in a real-world setting in the 2 years following implantation.Classification of EvidenceThis study provides Class IV evidence that ANT DBS reduces the frequency of seizures in patients with drug-resistant focal epilepsy.

UR - http://www.scopus.com/inward/record.url?scp=85158841057&partnerID=8YFLogxK

U2 - https://doi.org/10.1212/WNL.0000000000206887

DO - https://doi.org/10.1212/WNL.0000000000206887

M3 - Article

C2 - 36927882

SN - 0028-3878

VL - 100

SP - E1852-E1865

JO - Neurology

JF - Neurology

IS - 18

ER -

Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Drug-Resistant Epilepsy in the MORE Multicenter Patient Registry

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