NCT07798271 Optimizing Adaptive DBS for Parkinson's Disease
| NCT ID | NCT07798271 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Davis |
| Condition | PARKINSON DISEASE (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2026-05-08 |
| Primary Completion | 2032-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2026-05-08 with a primary completion date of 2032-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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., 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. Exclusion Criteria: * 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)
Contact & Investigator
Carina Oehrn, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT07798271 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PARKINSON DISEASE (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07798271 currently recruiting?
Yes, NCT07798271 is actively recruiting participants. Contact the research team at akabay@health.ucdavis.edu for enrollment information.
Where is the NCT07798271 trial being conducted?
This trial is being conducted at Davis, United States.
Who is sponsoring the NCT07798271 clinical trial?
NCT07798271 is sponsored by University of California, Davis. The principal investigator is Carina Oehrn, MD, PhD at University of California, Davis. The trial plans to enroll 35 participants.
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