Abstract
Background and Objectives
The efficacy of deep brain stimulation of the anterior nucleus of the thalamus (ANT DBS) in drug resistant epilepsy (DRE) patients was demonstrated in the double-blind Stimulation of the
Anterior Nucleus of the Thalamus for Epilepsy (SANTE) 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, QOLIE-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 that 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. Factors influencing SF reduction included number of implants per center. In patients with cognitive impairment, the reduction in median monthly seizure frequency was 26.0% by two 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 Death in Epilepsy (SUDEP) 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.
- Received September 23, 2021.
- Accepted in final form December 20, 2022.
- Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
This is an open access article distributed under the terms of the Creative Commons Attribution License 4.0 (CC BY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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