Objective: This is a new Essential Tremor (ET) patient registry for patients implanted with a multiple-source, constant-current DBS system capable of providing directionality for use in the management of ET motor symptoms.

Background: Treatment for Essential Tremor includes pharmacotherapy and ventral intermediate nucleus (VIM) thalamotomy, but thalamic Deep Brain Stimulation (DBS) is increasingly being utilized as the surgical-based therapy of choice. DBS of the VIM thalamus is recommended as a therapeutic option for appropriate patients with ET (1).

Method: This is a prospective, on-label, multi-center, international DBS registry conducted at up to 50 implanting centers. All participants are implanted with a multiple-source, constant-current DBS system (Vercise, Boston Scientific). Patients are followed for up to 3-years post implantation where their 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. Occurrence of adverse events will also be documented.

Results: To date, a total of 18 patients have been implanted (age = 65.9±17.1 years [Mean (SD)], 61% male)  with a disease duration of 15.1-years. A 19.9-point change in QUEST Summary Index was noted at 6-months (n = 11) and is clinically significant (4.47-point change MCID) (2). Based on severity scale of FTMTRS, all patients reported mild disability at  6-months  (88.9% with  moderate  disability  and  5.6% with mild disability  at baseline). All  patients reported improvement based on Clinical Global Impression of Change.

Conclusion: Large patient data registries can facilitate new insights regarding real world, clinical use of DBS. Additionally, as reported recently, directional DBS offers the potential for expansion of the therapeutic window via improved targeting of relevant neural substrates while concurrently minimizing inadvertent, off-target stimulation that in turn can cause adverse effects (3-6). This on-going registry represents the first comprehensive, large scale collection of real-world outcomes and evaluation of safety and effectiveness of a multiple-source, constant-current DBS system capable of providing directionality for use in the treatment of Essential Tremor.

References: 1. ElbleR J, Shih L, Cozzens JW. Surgical treatments for essential tremor. Expert Rev Neurother. 2018 Apr;18(4):303-321.
2. Pinté D, Makkos A, Kovács M, Janszky J, Kovács N. Minimal clinically important difference for the quality of life in essential tremor questionnaire. Mov Disord. 2019 May;34(5):759-760.
3. Dembek TA, Reker P, Visser-Vandewalle V, et al. Directional DBS increases side-effect thresholds-A prospective, double-blind trial. Mov Disord 2017 Oct;32(10):1380-1388.
4. Bruno S, Nikolov P, Hartmann CJ, Trenado C, Slotty PJ, Vesper J, Schnitzler A, Groiss SJ. Directional Deep Brain Stimulation of the Thalamic Ventral Intermediate Area for Essential Tremor Increases Therapeutic Window.
Neuromodulation. 2021 Feb;24(2):343-352.
5. Rammo RA, Ozinga SJ, White A, Nagel SJ, Machado AG, Pallavaram S, Cheeran BJ, Walter BL. Directional Stimulation in Parkinson’s Disease and Essential Tremor: The Cleveland Clinic Experience. Neuromodulation. 2021 Mar 18.
6. Roque DA, Hadar E, Zhang Y, Zou F, Murrow R. Reducing Ataxic Side Effects from Ventral Intermediate Nucleus of the Thalamus Deep Brain Stimulation Implantation in Essential Tremor: Potential Advantages of Directional Stimulation. Stereotact Funct Neurosurg. 2021 Sep 15:1-9.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/prospective-multicenter-international-registry-of-deep-brain-stimulation-for-essential-tremor/