Tremor Reduction using DBS: Outcomes of a Real-world, Prospective, Multicenter Essential Tremor Registry
Guenther Deuschl1, Griet Loret2, Norbert Kovacs3, Frederik Clement4, P.R. Schuurman5
1Universitaetsklinikum Schleswig-Holstein, 2AZ Sint Lucas, 3University of Pécs, 4AZ Delta, 5Academic Medical Centre (Amsterdam UMC)
Objective:

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.

Background:

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).

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

Results:

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).  

Conclusions:

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.

10.1212/WNL.0000000000201927