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

Jukka Peltola; Albert A. Colon; Jose Pimentel; Volker Coenen; Antonio Gil-Nagel; Antonio Goncalves Ferreira; Kai S. Lehtimaki; Philippe Ryvlin; Rod Taylor; Linda Ackermans; Jacqueline Ardesch; Carla G. Bentes; Magdalena Bosak; Jorge E. Burneo; Clara Chamadoira; Christian Elger; Lorand Eross; Daniel Fabo; Howard Faulkner; Jacek Gawlowicz; Alireza Gharabaghi; Maurizio Iacoangeli; Jozsef Janszky; Soila H. Jarvenpaa; Elisabeth Kaufmann; Kuan H. Kho; Eva Kumlien; Helmut Laufs; Christian Lettieri; Paulo Linhares; Soheyl Noachtar; Andrew K. Parrent; Ekaterina Pataraia; Nikunj K. Patel; Ana Rita Peralta; Attila Racz; Alexandre Rainha A. Campos; Ricardo Rego; Riccardo 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; MORE Study Group

doi: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 A. Colon, Jose Pimentel, Volker Coenen, Antonio Gil-Nagel, Antonio Goncalves Ferreira, Kai S. Lehtimaki, Philippe Ryvlin, Rod Taylor, Linda Ackermans, Jacqueline Ardesch, Carla G. Bentes, Magdalena Bosak, Jorge E. Burneo, Clara Chamadoira, Christian Elger, Lorand Eross, Daniel Fabo, Howard Faulkner, Jacek GawlowiczAlireza Gharabaghi, Maurizio Iacoangeli, Jozsef Janszky, Soila H. Jarvenpaa, Elisabeth Kaufmann, Kuan H. Kho, Eva Kumlien, Helmut Laufs, Christian Lettieri, Paulo Linhares, Soheyl Noachtar, Andrew K. Parrent, Ekaterina Pataraia, Nikunj K. Patel, Ana Rita Peralta, Attila Racz, Alexandre Rainha A. Campos, Ricardo Rego, Riccardo 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, MORE Study Group

^*Corresponding author for this work

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

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
Number of pages	14
Journal	Neurology
Volume	100
Issue number	18
DOIs	https://doi.org/10.1212/WNL.0000000000206887
Publication status	Published - 2 May 2023

Keywords

VAGUS NERVE-STIMULATION
LONG-TERM TREATMENT
ELECTRICAL-STIMULATION
ILAE COMMISSION
POSITION PAPER
FOLLOW-UP
NEUROSTIMULATION
CLASSIFICATION
THERAPY
ADULTS

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10.1212/WNL.0000000000206887Licence: CC BY

Cite this

Peltola, J., Colon, A. A., Pimentel, J., Coenen, V., Gil-Nagel, A., Goncalves Ferreira, A., Lehtimaki, K. S., Ryvlin, P., Taylor, R., Ackermans, L., Ardesch, J., Bentes, C. G., Bosak, M., Burneo, J. E., Chamadoira, C., Elger, C., Eross, L., Fabo, D., Faulkner, H., ... MORE Study Group (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{2a71a0baecd64d8f9cf8d2bce3d0803c,

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.",

keywords = "VAGUS NERVE-STIMULATION, LONG-TERM TREATMENT, ELECTRICAL-STIMULATION, ILAE COMMISSION, POSITION PAPER, FOLLOW-UP, NEUROSTIMULATION, CLASSIFICATION, THERAPY, ADULTS",

author = "Jukka Peltola and Colon, {Albert A.} and Jose Pimentel and Volker Coenen and Antonio Gil-Nagel and {Goncalves Ferreira}, Antonio and Lehtimaki, {Kai S.} and Philippe Ryvlin and Rod Taylor and Linda Ackermans and Jacqueline Ardesch and Bentes, {Carla G.} and Magdalena Bosak and Burneo, {Jorge E.} and Clara Chamadoira and Christian Elger and Lorand Eross and Daniel Fabo and Howard Faulkner and Jacek Gawlowicz and Alireza Gharabaghi and Maurizio Iacoangeli and Jozsef Janszky and Jarvenpaa, {Soila H.} and Elisabeth Kaufmann and Kho, {Kuan H.} and Eva Kumlien and Helmut Laufs and Christian Lettieri and Paulo Linhares and Soheyl Noachtar and Parrent, {Andrew K.} and Ekaterina Pataraia and Patel, {Nikunj K.} and Peralta, {Ana Rita} and Attila Racz and Campos, {Alexandre Rainha A.} and Ricardo Rego and Riccardo Ricciuti 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 {MORE Study Group}",

year = "2023",

month = may,

day = "2",

doi = "10.1212/WNL.0000000000206887",

language = "English",

volume = "100",

pages = "E1852--E1865",

journal = "Neurology",

issn = "0028-3878",

publisher = "LIPPINCOTT WILLIAMS & WILKINS",

number = "18",

}

Peltola, J, Colon, AA, Pimentel, J, Coenen, V, Gil-Nagel, A, Goncalves Ferreira, A, Lehtimaki, KS, Ryvlin, P, Taylor, R, Ackermans, L, Ardesch, J, Bentes, CG, Bosak, M, Burneo, JE, Chamadoira, C, Elger, C, Eross, L, Fabo, D, Faulkner, H, Gawlowicz, J, Gharabaghi, A, Iacoangeli, M, Janszky, J, Jarvenpaa, SH, Kaufmann, E, Kho, KH, Kumlien, E, Laufs, H, Lettieri, C, Linhares, P, Noachtar, S, Parrent, AK, Pataraia, E, Patel, NK, Peralta, AR, Racz, A, Campos, ARA, Rego, R, Ricciuti, R, 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 & MORE Study Group 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 A.

AU - Pimentel, Jose

AU - Coenen, Volker

AU - Gil-Nagel, Antonio

AU - Goncalves Ferreira, Antonio

AU - Lehtimaki, Kai S.

AU - Ryvlin, Philippe

AU - Taylor, Rod

AU - Ackermans, Linda

AU - Ardesch, Jacqueline

AU - Bentes, Carla G.

AU - Bosak, Magdalena

AU - Burneo, Jorge E.

AU - Chamadoira, Clara

AU - Elger, Christian

AU - Eross, Lorand

AU - Fabo, Daniel

AU - Faulkner, Howard

AU - Gawlowicz, Jacek

AU - Gharabaghi, Alireza

AU - Iacoangeli, Maurizio

AU - Janszky, Jozsef

AU - Jarvenpaa, Soila H.

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 K.

AU - Pataraia, Ekaterina

AU - Patel, Nikunj K.

AU - Peralta, Ana Rita

AU - Racz, Attila

AU - Campos, Alexandre Rainha A.

AU - Rego, Ricardo

AU - Ricciuti, Riccardo

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 - MORE Study Group

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.

KW - VAGUS NERVE-STIMULATION

KW - LONG-TERM TREATMENT

KW - ELECTRICAL-STIMULATION

KW - ILAE COMMISSION

KW - POSITION PAPER

KW - FOLLOW-UP

KW - NEUROSTIMULATION

KW - CLASSIFICATION

KW - THERAPY

KW - ADULTS

U2 - 10.1212/WNL.0000000000206887

DO - 10.1212/WNL.0000000000206887

M3 - Article

C2 - 36927882

SN - 0028-3878

VL - 100

SP - E1852-E1865

JO - Neurology

JF - Neurology

IS - 18

ER -