Objective: To assess the procedures for introducing two adaptive deep brain stimulation (aDBS) modes (single and dual threshold) in Parkinson’s disease patients (PD) in a real-world setting.

Background: DBS is an effective therapy for PD symptoms, though opportunities exist to improve the efficiency and efficacy. Conventional DBS is programmed to run continuously (cDBS). In contrast, aDBS may individualize and optimize PD therapy by adjusting stimulation based on brain activity measured as local field potentials (LFPs) through the same DBS electrodes. Both the aDBS algorithms and brain sensing technology used in this study are uniquely embedded in the DBS system. Although this implantable Neurostimulator is available worldwide, its aDBS algorithms are currently approved only in Japan.

Method: PD patients implanted with DBS leads either in the internal globus pallidus (GPi) or subthalamic nucleus (STN) connected to the DBS system. Both single and dual threshold aDBS modes use LFP oscillations in the Beta band (8-30 Hz) as control signals but differ with respect to their trigger points and stimulation parameters. Subjects will enter a 30-day Baseline Phase in their current cDBS programming configuration, followed by an aDBS Set-up and Adjustment Phase. The aDBS adjustment phases will involve measures of on time, quality of life, movement, patient preference, and satisfaction, all measured against the cDBS baseline. An Apple Watch will be used to provide a continuous, objective monitoring of key motor symptoms of PD (eg. tremor and dyskinesia).

Results: The primary endpoint is the acceptability of a mode, which is defined as greater than or equal to cDBS efficacy with minimal side effects according to the aDBS Global Impression of Change Score (GIC). Other endpoints will include output from the apple watch, the MDS UPDRS III, EQ-5D- 5L, PDQ-39, UDysRS, and patient preference. Safety will include evaluation of stimulation-related adverse events (AEs), other AEs, and device deficiencies.

Conclusion: This multi-center post-market study, which is the first to assess aDBS in a real-world clinical setting will test the safety, tolerability, and efficacy of two different aDBS modes.  Moreover, it may provide guidance for the broader use of aDBS and an early glimpse into efficacy compared to cDBS.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/early-adapter-study-protocol-for-the-multi-center-post-market-study-of-adaptive-deep-brain-stimulation-adbs-in-japan/