Objective: In this report, preliminary data will be presented from a prospective, multicenter, international Essential Tremor (ET) outcomes study in which patients received a multiple independent constant current (MICC) Directional DBS system for treatment of their ET symptoms.

Background: High-frequency DBS has been demonstrated to be safe and effective in the treatment of several movement disorders including Parkinson’s disease, Essential Tremor, and Dystonia. DBS of ventral intermediate nucleus (Vim) is currently recommended as a therapeutic option for appropriate subjects with ET. ^1,2 Large, multi-center patient registries have the potential to provide insight on the use of DBS in the treatment of ET as used per routine clinical practice.

Method: 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 and overall improvement in quality of life and ET symptoms are evaluated. Clinical endpoints evaluated at baseline and during study follow-up timepoints include Quality of Life in Essential Tremor Questionnaire (QUEST), Fahn-Tolosa-Marin Rating Scale (FTMTRS), and Global Impression of change. Adverse events are also being collected.

Results: Preliminary results from this ongoing, prospective, multicenter, international outcomes study demonstrate significant improvement in ET related symptoms and quality of life up to 12-month follow-up. A total of 41 subjects (22 males, mean age = 65.5 years, mean disease duration = 19.9 years) received DBS. A mean 7.7-hour reduction in tremor was noted (self-reported, QUEST) compared with Baseline (14.4-hours at Baseline, 6.3-hours at 12-months) in a typical day. A clinically significant improvement in quality of life (∆ = 18.8-point in QUEST SI score, n = 18) at 12-months post-DBS was reported (MCID >4.47 points).³ According to clinicians, 18 out of 19 (94.7%) of the subjects demonstrated improvement at 12-months, while 1 (5.3%) subject reported no change. No lead breakages/fractures were reported.

Conclusion: Results from ongoing real-world study demonstrates significant reduction in tremor and improvement in quality of life in Essential Tremor patients with the use of a Directional DBS systems capable of multiple independent current control (MICC).

References: 1. Wharen, R. E., Jr., Okun, M. S., Guthrie, B. L., Uitti, R. J., Larson, P., Foote, K., Walker, H., Marshall, F. J., Schwalb, J., Ford, B., Jankovic, J., Simpson, R., Dashtipour, K., Phibbs, F., Neimat, J. S., Stewart, R. M., Peichel, D., Pahwa, R., Ostrem, J. L., & Group, S. D. E. S. (2017). Thalamic DBS with a constant-current device in essential tremor: A controlled clinical trial. Parkinsonism Relat Disord, 40, 18-26.
2. Zesiewicz, T. A., Elble, R., Louis, E. D., Hauser, R. A., Sullivan, K. L., Dewey, R. B., Jr., Ondo, W. G., Gronseth, G. S., Weiner, W. J., & Quality Standards Subcommittee of the American Academy of, N. (2005). Practice parameter: therapies for essential tremor: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology, 64(12), 2008-2020.
3. Pintér D, Makkos A, Kovács M, Janszky J, Kovács N. Minmal clinically important difference for the quality of life in essential tremor questionnaire. Mov Disord. 2019 May;34(5):759-760.

« Back to 2023 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/tremor-reduction-using-dbs-outcomes-of-a-real-world-prospective-multicenter-essential-tremor-registry/