What this study is
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.
What's being tested
- aDBS-Extended (Medtronic Percept™)
Intervention · DEVICE
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 (Medtronic Percept™)
Intervention · DEVICE
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.
- Continuous DBS (cDBS) - Active Control (Medtronic Percept™)
Intervention · DEVICE
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.
Study details
- Official title
- Optimizing Adaptive Deep Brain Stimulation for Parkinson's Disease
- Sponsor
- University of California, Davis
- Conditions
- PARKINSON DISEASE (Disorder)
- Enrolling
- 35 people
- Starts
- 2026-05-08
- Est. completion
- 2032-07-01
- Design
- Triple-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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., stable LFP feature suitable for biomarker extraction) during screening
- Ability to speak and understand English sufficiently to provide informed consent and complete study procedures and assessments without an interpreter.
You can't join if
- Atypical or secondary parkinsonism (e.g., multiple system atrophy, progressive supranuclear palsy, vascular parkinsonism)
- Prior brain surgery other than STN DBS
- Clinically significant cognitive impairment or dementia, defined as MoCA < 24 or equivalent, or lacking capacity to provide informed consent
- Active psychiatric illness that could compromise safety or participation (e.g., uncontrolled depression, psychosis, severe anxiety disorder)
- History of suicidality or suicide attempt within the past year
- Clinically unstable medical conditions (e.g., uncontrolled hypertension, advanced cardiac or pulmonary disease) that would increase study risk
- Current substance abuse or dependence
- Ongoing participation in another interventional trial that could confound outcomes
- Pregnancy or plans to become pregnant during the study period
- Inability or unwillingness to comply with study procedures (e.g., at-home monitoring, study visits, data collection)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUC Davis Center for Neuroscience
Davis, California, United States
- Annie K Abay · Contact408-728-0148akabay@health.ucdavis.edu
Recruiting
Study team
Sponsor
University of California, Davis
Study ID 2354739
Principal investigator
Carina Oehrn, MD, PhD
University of California, Davis
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.