To assess 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.

Subthalamic nucleus (STN)-DBS is a standard therapeutic option for appropriately selected patients with advanced Parkinson’s disease. The advent of multiple source devices and leads with segmented contacts greatly increase the permutations of available DBS parameters.  Development of a computer-guided CLPA based on objective feedback from a finger-mounted motion sensor may make DBS programming easier and faster.

CLOVER-DBS (ClinicalTrials.gov Identifier: NCT03037398) is a prospective, randomized, 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 at STN for ≤6 months.  The CLPA would suggest iterative stimulation settings based on the motor outcome at previous settings, as measured by an accelerometer (Kinesia®, Great Lakes NeuroTechnologies).  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.

CLOVER-DBS assesses programming burden and clinical responses from stimulation settings generated by the CLPA and SOC.  Results from this study will help inform algorithm development and future studies.