Objective: To assess the feasibility and efficacy of a novel closed-loop programming algorithm (CLPA) for directional lead deep brain stimulation (DBS) based on objective feedback using a finger-mounted motion sensor.

Background: Subthalamic nucleus (STN)-DBS is a standard therapeutic option for appropriately selected patients with advanced Parkinson’s disease. Recent advancements in DBS technology have enabled additional combinations of stimulation settings, although the identification of optimal stimulation parameters has become more complicated. In particular, the advent of multiple source devices and leads with segmented contacts greatly increase the permutations of available parameters. Development of a computer-guided CLPA based on objective feedback from a finger-mounted motion sensor may make DBS programming easier and faster.

Methods: CLOVER-DBS is a prospective, randomized, multi-center, double-blind study employing a crossover design. Up to 36 subjects will be enrolled who have been implanted with bilateral directional DBS leads (Vercise Cartesia, Boston Scientific) connected to a pulse generator providing an independent current source for each of 16 contacts in the STN for at least 6 months. These subjects have been previously optimized per the center’s standard of care (SOC) with unchanged programming settings over 4 weeks. The CLPA would suggest iterative stimulation settings based on the motor outcome at previous settings, as measured by an accelerometer (Kinesia®, Great Lakes NeuroTechnologies). The number of programming steps needed to achieve the final setting identified as optimal are tracked. Additionally, motor outcomes are measured by accelerometer as well as by the Unified Parkinson’s Disease Rating Scale Part III (UPDRS-III) by a blinded neurologist, at baseline and after each programming method, in a random order.

Results: This evaluation has no prospective statistical hypothesis, but collects number of programming steps, UPDRS-III, and quantitative accelerometer-based measures of bradykinesia and tremor. The preliminary data obtained so far will be reported.

Conclusions: The CLOVER-DBS study will compare programming effort and clinical responses from stimulation settings generated by the CLPA and the SOC. Results will inform algorithm development and future studies.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/clover-dbs-a-prospective-multi-center-clinical-study-with-blinding-to-evaluate-a-closed-loop-programming-algorithm-for-directional-leads-based-on-external-feedback/