Objective: To examine the effectiveness of a Deep Brain Stimulation (DBS) system with 16-contact Directional Leads for the treatment of Parkinson’s Disease (PD).

Background: Directional DBS leads have been recently developed to expand the therapeutic window while minimizing stimulation-induced side effects.^1-3 Current directional Leads enable more precise targeting of specific brain regions using multiple independent current control through segmented leads with eight contacts across four levels. In this study, we tested the effectiveness of two novel 16-contact directional leads (3-3-3-3-3-1 and 3-3-3-3-1-1-1-1 configuration) for the treatment of symptoms of PD.

Method: For this prospective, multi-center, open-label confirmatory study, we enrolled patients with PD eligible for DBS based on clinical indication. Each subject received a Multiple Independent Current Controlled DBS system which included two 16-contact directional leads targeting bilaterally the subthalamic nucleus. Subjects were followed from device activation through the primary effectiveness endpoint of 3-months. Follow-up assessments were carried at 6 and 12-months follow up. During each visit, DBS programming was carried per clinician’s standard of care and the following assessments were collected: MDS-UPDRS I-IV, PDQ-39, antiparkinsonian medication use, and global impression of change.

Results: We present preliminary findings from 49 subjects (40 male, mean age=62.5±6.7 years, mean disease duration=11.7 ± 4.1 years). At 3-months post DBS activation, compared to Baseline (pre-DBS), motor symptoms significantly improved by an absolute difference of 20-points (Meds-OFF, MDS-UPDRS III, p<0.0001). Mean change in medication use was significantly lower between Baseline and 12-weeks (32% reduction, p<0.001). Quality of life improvement (6.1-point improvement, p<0.005) was also observed at 3-months. These improvements persisted through 6 and 12-month follow up.

Conclusion: Results from this study confirm the effectiveness of a DBS system delivering stimulation to the STN via novel 16-contact directional leads to manage PD symptoms. Our data demonstrate the usefulness of a new DBS system that extend the span of directional contacts and open new avenues to deliver multi-level stimulation to manage PD symptoms.

References: 1. L. Timmermann, R. Jain, L. Chen, M. Maarouf, M.T. Barbe, N. Allert, et al. “Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson’s disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study,” Lancet Neurol. 2015 Jul;14(7):693-701.
2. Steigerwald F, Müller L, Johannes S, et al. Directional deep brain stimulation of the subthalamic nucleus: A pilot study using a novel neurostimulation device. Mov Disord. 2016 Aug; 31(8): 1240–1243.
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.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/clinical-efficacy-of-a-novel-deep-brain-stimulation-system-with-16-contact-directional-leads-for-the-treatment-of-parkinsons-disease/