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.

Method: In this prospective, on-label, multi-center, international DBS registry, enrolled patients are implanted with a directional MICC-based DBS system. 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: Preliminary results from this ongoing registry demonstrate significant improvement in ET related symptoms and quality-of-life up at 6- and 12-month follow-up. A total of 63-patients (32 male, 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.

Conclusion: 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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MDS Abstracts - https://www.mdsabstracts.org/abstract/real-world-clinical-and-safety-outcomes-from-a-prospective-multicenter-deep-brain-stimulation-registry-of-essential-tremor-patients-2/