Optimizing Adaptive Deep Brain Stimulation for Parkinson's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adaptive deep brain stimulation (aDBS) automatically adjusts stimulation based on brain activity. This study compares more thorough brain-signal characterization in the clinic and chronic home recordings to the standard clinic-based approach, to see if these data improve aDBS programming and clinical outcomes. It uses sensing-enabled DBS devices to collect brain signals during daily life and across medication states, with two sequential parts evaluating in-clinic characterization and at-home monitoring. Participants are adults with idiopathic Parkinson's disease, bilateral STN DBS, and stable medication and DBS settings. The study compares aDBS-Extended, aDBS-Standard, and continuous DBS with active control.

Why it matters

Who can join: the full rules

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)

Where it's running

• UC Davis Center for Neuroscience
  Davis, California, United States Recruiting

Study contacts

• Principal investigator: Carina Oehrn, MD, PhD — University of California, Davis
• Study coordinator: Annie K Abay, B.S.
• Email: akabay@health.ucdavis.edu
• Phone: 408-728-0148

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.