Real-world Clinical and Safety Outcomes from a Prospective: Multicenter Deep Brain Stimulation Registry of Essential Tremor Patients
Guenther Deuschl1, Rick Schuurman2, Griet Loret3, Norbert Kovacs4, Michael Barbe5, Marta Blazquez Estrada6, Frederik Clement7, Jung-Il Lee8, Serge Jaumà Classen9, David Pedrosa10, Jens Volkmann11, Ana Oliveira12, Steffen Paschen13, Rajat Shivacharan14, Edward Goldberg14
1Dept. of Neurology, Christain-Albrechts Univ, 2Academic Medical Centre (Amsterdam UMC), 3UZ Gent, Dienst Neurologie, 4University of Pecs, 5University Hospital Cologne, 6Hospital Universitario Central de Asturias (HUCA), 7AZ Delta, 8Samsung Medical Center, 9Bellvitge University Hospital, 10University Hospital Giessen and Marburg, 11University Hospital of Wuerzburg, 12Hospital Vila Franca de Xira, 13University Hospital Schleswig-Holstein, 14Boston Scientific Neuromodulation
Objective:
To evaluate real-world clinical and safety outcomes of patients with Essential Tremor (ET) treated using a directional Deep Brain Stimulation (DBS) system with Multiple Independent Current Control (MICC).
Background:
ET has been reported to affect about 0.9% of the world population. DBS targeting the ventral intermediate nucleus (Vim) is the preferred surgical treatment for medication-refractory ET. MICC-enabled directional DBS systems may offer improved symptom control and programming flexibility. Real-world data are needed to validate these benefits across diverse clinical settings.
Design/Methods:
This ongoing, prospective, multicenter international registry (NCT04032470) includes up to 500 ET patients implanted with Boston Scientific Vercise DBS systems. Assessments include tremor severity (TETRAS), quality of life (QUEST), and Clinical Global Impression of Change (CGI). Safety data were collected via adverse event reporting.
Results:
Among 88 enrolled subjects, 73 were activated. Mean age was 66.3 years, and mean disease duration was 20.4 years. At 2 years post-DBS, patients reported a 46% reduction in tremor hours (mean increase of 7.5 hours/day without tremor, p<0.001). QUEST Summary Index improved by 23.4 points (p<0.001), exceeding the threshold for clinical significance. TETRAS scores showed a 41% improvement in tremor severity and 60% improvement in activities of daily living, sustained through 2 years. Over 95% of clinicians and 93% of patients reported symptom improvement at 6 months, sustained at 2 years. Data collection is on-going and updated results will be presented.
Conclusions:
Directional DBS with MICC demonstrates sustained symptom relief and quality-of-life improvements in ET patients. High satisfaction rates and consistent safety outcomes support its clinical utility. Preliminary registry data confirm that MICC-enabled directional DBS systems offer significant, durable benefits for ET patients in real-world settings. These findings support broader adoption of advanced DBS technologies.
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