Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Drug-Resistant Epilepsy in the MORE Multicenter Patient Registry
Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology..
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.
| Errataetall: |
CommentIn: Neurology. 2023 May 2;100(18):845-846. - PMID 36941073 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:100 |
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| Enthalten in: |
Neurology - 100(2023), 18 vom: 02. Mai, Seite e1852-e1865 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Peltola, Jukka [VerfasserIn] |
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| Links: |
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| Themen: |
Journal Article |
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| Anmerkungen: |
Date Completed 03.05.2023 Date Revised 25.01.2024 published: Print-Electronic ClinicalTrials.gov: NCT01521754 CommentIn: Neurology. 2023 May 2;100(18):845-846. - PMID 36941073 Citation Status MEDLINE |
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| doi: |
10.1212/WNL.0000000000206887 |
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| 500 | |a Date Revised 25.01.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01521754 | ||
| 500 | |a CommentIn: Neurology. 2023 May 2;100(18):845-846. - PMID 36941073 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a DISCUSSION: The MORE registry supports the effectiveness and safety of ANT DBS therapy in a real-world setting in the 2 years following implantation | ||
| 520 | |a CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that ANT DBS reduces the frequency of seizures in patients with drug-resistant focal epilepsy | ||
| 520 | |a TRIAL REGISTRATION INFORMATION: MORE ClinicalTrials.gov Identifier: NCT01521754, first posted on January 31, 2012 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
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| 700 | 1 | |a Pataraia, Ekaterina |e verfasserin |4 aut | |
| 700 | 1 | |a Patel, Nikunj K |e verfasserin |4 aut | |
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| 700 | 1 | |a Rácz, Attila |e verfasserin |4 aut | |
| 700 | 1 | |a Campos, Alexandre Rainha |e verfasserin |4 aut | |
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| 700 | 1 | |a Sprengers, Mathieu |e verfasserin |4 aut | |
| 700 | 1 | |a Sufianov, Albert |e verfasserin |4 aut | |
| 700 | 1 | |a Temel, Yasin |e verfasserin |4 aut | |
| 700 | 1 | |a Theys, Tom |e verfasserin |4 aut | |
| 700 | 1 | |a Van Paesschen, Wim |e verfasserin |4 aut | |
| 700 | 1 | |a Van Roost, Dirk |e verfasserin |4 aut | |
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| 700 | 1 | |a Franco, Ana |e investigator |4 oth | |
| 700 | 1 | |a Hackelberg, Birte |e investigator |4 oth | |
| 700 | 1 | |a Hampel, Kevin |e investigator |4 oth | |
| 700 | 1 | |a Hirsch, Dr Martin |e investigator |4 oth | |
| 700 | 1 | |a Meyne, Johannes Konrad |e investigator |4 oth | |
| 700 | 1 | |a Kovács, Norbert |e investigator |4 oth | |
| 700 | 1 | |a Lang, Nicolas |e investigator |4 oth | |
| 700 | 1 | |a Möddel, Gabriel |e investigator |4 oth | |
| 700 | 1 | |a Moeller, Bettina |e investigator |4 oth | |
| 700 | 1 | |a Mondani, Dr Massimo |e investigator |4 oth | |
| 700 | 1 | |a Nass, Robert D |e investigator |4 oth | |
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| 700 | 1 | |a Obszanska, Dr Katarzyna |e investigator |4 oth | |
| 700 | 1 | |a Orlov, Alexander |e investigator |4 oth | |
| 700 | 1 | |a Pietraszko, Wojciech |e investigator |4 oth | |
| 700 | 1 | |a Scerrati, Massimo |e investigator |4 oth | |
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