Prospective, Multicenter, International Registry of Deep Brain Stimulation for Dystonia: Sub-analysis of Cervical Dystonia Patients
Alberto Albanese1, Alfons Schnitzler2, Andrea Kuehn3, David Arkadir4, David Ledingham5, David Pedrosa6, Edward Newman7, Ignacio Regidor8, Jens Volkmann9, Marcin Rudas10, Maria Fiorella Contarino11, Mariachiara Sensi12, Michael Barbe13, Monika Poetter-Nerger14, Norbert Kovacs15, Ralph Lehrke16, Ryoong Huh17, Steffen Paschen18, Tomasz Mandat19, Tommaso Tufo20, Veerle Visser-Vandewalle21, Volker Coenen22, Yen Tai23, Lilly Chen24, Edward Goldberg24, Joachim Krauss25
1Universita Cattolica Sacro Cuore, 2Heinrich Heine University, Neurology, 3Charité Universitätsmedizin Berlin, 4Hadassah Medical Center, 5Newcastle University, 6Philipps-University Marburg, 7Glasgow Royal Infirmary, 8Hospital Universitario Ramón y Cajal, 9Universitätsklinikum Würzburg, 10Jan Biziel University Hospital No 2, Collegium Medicum, Nicolaus Copernicus University, 11Lieden University Medical Center, 12Azienda Ospedaliero-Universitaria S, Anna, 13University Hospital Cologne, 14University Medical Center Hamburg - Eppendorf, 15University of Pécs, 16St. Barbara-Hospital, Hamm, 17Catholic University of Seoul, 18University Hospital Schleswig-Holstein, Campus Kiel and Kiel University, 19Narodowy Instytut Onkologii Im. Marii Sk, 20Fakeeh University Hospital, 21Faculty of Medicine and University Hospital Cologne, 22University Medical Center, Faculty of Medicine, University of Freiburg, 23Imperial College London, 24Boston Scientific, 25Hannover Medical School
Objective:
The study objective is to assess/report real-world outcomes of patients with idiopathic, inherited, or acquired dystonia implanted with Multiple Independent Current Control (MICC)-based directional Deep Brain Stimulation (DBS) systems.
Background:
In patients with cervical (focal) versus generalized dystonia, optimal DBS target sites (within pallidothalamic loop) are thought to diverge and be specific for particular connections. DBS devices equipped with capabilities such as directionality and Multiple Independent Current Control (MICC) may enable improved outcomes.
Design/Methods:
This is a sub-analysis of patients with focal (cervical) dystonia only or cervical dystonia in context of segmental or generalized dystonia derived from a prospective, multicenter, international dystonia registry (NCT02686125). All patients receive an MICC-based, directional DBS system (Boston Scientific). Patients are followed up to 3-years (post-implant). The following assessments collected to evaluate dystonia symptoms include: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), quality-of-life, overall satisfaction, and adverse events.
Results:
A total of 50-patients (mean age 56.1-years, 62% females) with focal (cervical) dystonia only, and 95-patients (mean 43.6-years, 58% females) with cervical dystonia in context of segmental or generalized dystonia have been evaluated to date. In cervical only cohort, a 20-point improvement in overall TWSTRS score was noted at 6-months (n=35) and sustained up to 1-year (23.1-point improvement, n=30). In those with cervical dystonia in context of segmental or generalized dystonia, an 8.3- and 7.8-point improvement in overall TWSTRS scores was noted at 6- (n=62) and 12-months (n=48), respectively. Both evaluated groups reported the following level of improvement versus Baseline (Global-Impression-of-Change) at 12-months follow-up: 84% with cervical only and 82% of patients with cervical and other involved regions.
Conclusions:
This registry represents the first comprehensive, large-scale collection of real-world outcomes associated with dystonia patients implanted with directional, MICC-based DBS systems. Preliminary results demonstrate significant improvement in cervical dystonia patients (alone or in context of segmental or generalized dystonia) following DBS.