To evaluate outcomes of directional DBS systems with Multiple Independent Current Control (MICC) technology when implanted in patients with Essential Tremor (ET) as standard of care.

ET is one of the most common neurological diseases affecting about 0.9% of the world population.  Medical treatment is focused on management of motor symptoms, and therapeutic options include pharmacotherapy, ventral intermediate nucleus (Vim) thalamotomy, and/or thalamic Deep Brain Stimulation (DBS). Currently, Vim DBS is recommended as a therapeutic option for appropriate subjects with ET (Wharen 2017, Zesiewicz 2005).

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 overall improvement in quality of life and ET symptoms are evaluated. Adverse events are also being collected.

To date, 30-patients have been implanted (age = 64.8 ± 15.1 years [Mean (SD)], 53.1% male) with a mean disease duration of 19.3-years. A 17.3-point change in QUEST Summary Index was noted at 12-months representing a clinically significant difference (>4.47-point change) (Pinter 2019). In addition, a mean 9-hours of tremor reduction in a typical day was noted (14.7-hours at Baseline versus 6.5-hours at 12-months) . Moreover, based on the severity scale of FTMTRS, when comparing disability at 12-months (vs Baseline), no patient reported experiencing marked disability (vs. 9.4% at Baseline), 16.7% reported moderate disability (vs. 81.3% at Baseline) and 83.3% reported mild disability  (vs 9.4% at Baseline).  

Preliminary results from this ongoing registry show clinically important outcomes in quality of life, as well as motor function, thereby reflecting improvement in overall disability among patients (i.e., a disability profile moving from moderate/severe to more mild/moderate disability). This registry represents the first comprehensive, large-scale collection of real-world outcomes with MICC-based DBS systems for ET.