Real-world Outcomes from a Prospective, Multicenter Deep Brain Stimulation Registry of Essential Tremor Patients
Guenther Deuschl1, Norbert Kovacs2, Griet Loret3, Michael Barbe4, Jung Il-Lee5, Frederi C Clement6, Marta Blazquez-Estrada7, Serge Jaumà Classen8, David Pedrosa9, Jens Volkmann10, Ana Oliveira11, Steffen Paschen12, P.R. Schuurman13, Lilly Chen14, Edward Goldberg14
1Dept. of Neurology, Christain-Albrechts Univ, 2University of Pécs, 3UZ Gent, Dienst Neurologie, 4University Hospital Cologne, 5Samsung Medical Center, Sungkyunkwan University School of Medicine, 6AZ Delta, 7Hospital Universitario Central de Asturias (HUCA), 8Bellvitge University Hospital, 9University Hospital Giessen and Marburg, 10Universitätsklinikum Würzburg, 11CHU de São João, Porto University, 12University Medical Center Schleswig Holstein, 13Academic Medical Centre (Amsterdam UMC), 14Boston Scientific Neuromodulation
Objective:
Here, we evaluate on-going registry outcomes derived from patients implanted with directional Deep Brain Stimulation systems with Multiple Independent Current Control (MICC) technology for treatment of Essential Tremor.
Background:
Large, multicenter patient outcome registries are an important source from which to collect real-world evidence (RWE). Ventral intermediate nucleus (Vim) Deep Brain Stimulation (DBS) is an increasingly recommended therapeutic approach in properly selected candidates to manage Essential Tremor (ET). This clinical evaluation will help provide RWE in patients implanted with a DBS system for ET.
Design/Methods:
In this prospective, on-label, multi-center, international DBS registry, enrolled patients are implanted with a directional MICC-based DBS system (Vercise, Boston Scientific). Patients are followed up to 3-years where ET symptoms and overall improvement in quality of life are evaluated. Clinical endpoint evaluated at baseline and during study follow-up timepoints include Fahn-Tolosa-Marin Rating Scale (FTMTRS), the Essential Tremor Rating Assessment Scale (TETRAS), Quality of Life in Essential Tremor Questionnaire (QUEST), and Global Impression of change. Adverse events are also being collected.
Results:
Results from this ongoing, prospective, multicenter, international outcomes study demonstrate significant improvement in ET related symptoms and quality of life up to 12-month follow-up. A total of 50 subjects (27 males, mean age= 65.3 years, mean disease duration = 19.5 years) received DBS. At the 12-month follow-up, a mean 8.9-hours reduction in tremor was noted (self-reported, QUESD in a typical day. Additionally, regarding tremor severity, no subject reported marked disability while 82.6% reported mild disability (FTMTRS), and subjects saw a 63.7% mean-improvement in activities of daily living (TETRAS) at 12-months compared to baseline. No lead breakages/fractures were reported.
Conclusions:
Results from this ongoing, prospective, multicenter, international real-world outcomes study using multiple-source constant-current Directional DBS Systems for the treatment of Essential Tremor continue to demonstrate positive outcomes out to 12-months follow-up.