University of California, Davis
Parkinson's disease (PD) affects more than 10 million people worldwide and causes progressive motor symptoms such as slowness, stiffness and tremor. For patients whose symptoms are no longer adequately controlled with medication, deep brain stimulation (DBS) can substantially improve motor function. More recently, adaptive DBS (aDBS) has become available. Unlike conventional DBS, which delivers continuous stimulation, aDBS automatically adjusts stimulation in response to brain activity recorded by the implanted device. Current clinical aDBS programming is based primarily on brief recordings obtained during clinic visits. However, Parkinson's symptoms and the underlying brain signals change throughout the day in response to medication, daily activities and other factors. As a result, recordings collected during a single clinic visit may not fully capture the neural activity that best reflects a patient's symptoms in everyday life. The purpose of this study is to determine whether incorporating long-term brain recordings collected during daily life improves adaptive DBS programming and clinical outcomes. Participants will first undergo in-clinic testing to identify brain signals associated with their symptoms. Brain activity and symptoms will then be monitored during everyday life using the sensing capabilities of the implanted DBS device. Participants with suitable brain signals will enter a randomized, blinded crossover study comparing three stimulation approaches: conventional continuous DBS, adaptive DBS programmed using the current clinic-based approach and adaptive DBS programmed using both clinic and at-home recordings. The study will compare the effects of these approaches on motor fluctuations and quality of life. It will also determine how frequently different brain signals occur in people with Parkinson's disease and how well they reflect motor symptoms, providing information that may improve future adaptive DBS therapies.
Adaptive deep brain stimulation (aDBS) automatically adjusts stimulation based on brain activity recorded by an implanted deep brain stimulation (DBS) system. Current clinical programming of aDBS relies on recordings of brain activity collected during brief clinic visits. However, Parkinson's disease symptoms and the underlying brain activity fluctuate throughout the day in response to medication, daily activities and other factors. It is unknown whether recordings collected during routine clinic visits adequately capture the brain signals needed to optimize adaptive DBS for everyday life. Co…
Inclusion Criteria: * Subjects will be 18 and over * Clinical diagnosis of idiopathic Parkinson's disease (PD), consistent with MDS diagnostic criteria * Motor fluctuations in response to medication * Bilateral subthalamic nucleus (STN) DBS using a commercial sensing-enabled device * Stable cDBS settings for ≥3 months prior to enrollment * Stable antiparkinsonian medication regimen for ≥4 weeks prior to enrollment * Capacity to provide informed consent * Ability and willingness to complete study visits and at-home monitoring * For Part 2: Presence of an adequate STN neural signal (e.g., stabl…
All parameters are derived from Steps 2-4. Amplitude modulation is based on individualized biomarker thresholds established through in-clinic and at-home testing, within the participant's effective stimulation amplitude range. Delivered via implanted Medtronic Percept™ DBS system using FDA-approved settings.
aDBS-Standard, with stimulation parameters optimized by an independent clinician using the current standard clinical programming procedure, with iterative programming across multiple visits as needed.
Participants receive their clinically optimized continuous DBS settings without adaptive modulation. Adaptive DBS parameters are configured to maintain blinding, but stimulation amplitude remains fixed at the standard cDBS level. Active stimulation is delivered throughout the study via the implanted Medtronic Percept™ DBS system.