Automated Data-Driven Optimization of Adaptive Deep Brain Stimulation Parameters for Parkinsons Disease Patients with Percept Neurostimulator

What this Trial Is About

Parkinsons disease PD is a disabling condition affecting about 1% of people over 60, often causing motor fluctuations and dyskinesias as it progresses. While medications help early symptoms, many patients require deep brain stimulation DBS, a surgical therapy involving implanted electrodes that deliver continuous electrical stimulation to the brain. Traditional DBS uses constant stimulation that does not adjust to a patients changing symptoms throughout the day. Adaptive DBS aDBS addresses this by automatically adjusting stimulation in real-time based on neural signals, and was FDA-approved for PD treatment with the Medtronic Percept PC and RC devices in 2025. This study evaluates a data-driven automated pipeline designed to recommend adaptive control parameters for aDBS to overcome barriers in widespread use that require specialized knowledge and trial-and-error adjustments. Participants with PD implanted with the Percept device will receive either standard constant DBS cDBS or aDBS programmed with parameters suggested by this pipeline. The study includes a randomized, blinded crossover design where patients alternate between aDBS and cDBS during awake hours in counterbalanced blocks lasting 1 to 7 days. The study comprises several phases short-term aDBS testing during in-clinic sessions, followed by longer-term at-home use of aDBS, with regular assessments. Participants will undergo brain recordings, clinical assessments, and use wearable monitors to track symptoms and quality of life. Researchers will measure changes in bothersome movement symptoms, quality of life, and electrical energy delivered over about one year. Safety is monitored with manual review of pipeline recommendations before programming the device and patients can revert to baseline settings at any time. The study aims to improve management of PD symptoms by optimizing aDBS parameters using automated methods, with close follow-up throughout the trial duration.

Automated Daytime Adaptive Deep Brain Stimulation Parameter Optimization in Patients Implanted With Percept Neurostimulator