Real-world Clinical Outcomes from a Prospective, Multicenter Deep Brain Stimulation Registry of Essential Tremor Patients
Guenther Deuschl1, Rick Schuurman2, Griet Loret3, Norbert Kovacs4, Marta Blazquez Estrada5, Jung-Il Lee6, Jens Volkmann7, David Pedrosa8, Ana Oliveira9, Steffen Paschen10, Lilly Chen11, Rajat Shivacharan11, Edward Goldberg11
1Dept. of Neurology, Christain-Albrechts Univ, 2University of Amsterdam (AMC), 3UZ Gent, Dienst Neurologie, 4University of Pécs, 5Hospital Universitario Central de Asturias (HUCA), 6Samsung Medical Center, Sungkyunkwan University School of Medicine, 7University Hospital of Wuerzburg, 8University Hospital Giessen and Marburg, 9CHU de São João, Porto University, 10University Hospital Schleswig-Holstein, 11Boston Scientific Neuromodulation
Objective:
Here, we evaluate ongoing registry outcomes derived from patients implanted with directional Deep Brain Stimulation (DBS) systems with Multiple Independent Current Control (MICC) technology for treatment of Essential Tremor (ET).
Background:
Large, multicenter patient outcome registries are an important source from which to collect real-world clinical evidence. Ventral intermediate nucleus (Vim) DBS is a widely accepted therapeutic approach in properly selected candidates to manage ET. This clinical evaluation will help provide evidence 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 registry demonstrate significant improvement in ET related symptoms and quality-of-life up to 12-month follow-up. A total of 63-patients (32 males, mean age= 66.1 years, mean disease duration = 20.4 years) received DBS. At the 12-month follow-up, a mean 7.4-hours/day reduction in tremor was noted (self reported, QUEST). Clinically significant quality-of-life improvement was observed at 6-months (mean QUEST SI score Δ from Baseline of 18.3 points; n = 39), and at 12-months (mean Δ in QUEST SI score from Baseline of 23.0 points; n = 33). No lead breakages/fractures were reported. Additional clinical and safety outcomes derived from on-going data collection and analysis will be 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 after 12-months follow-up.
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