Recruiting

aDBS, DBS, Conventional

Sponsor:

UCLA

Code:

NCT07798271

Conditions

PARKINSON DISEASE (Disorder)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

aDBS-Extended (Medtronic Percept™)

aDBS-Standard (Medtronic Percept™)

Continuous DBS (cDBS) - Active Control (Medtronic Percept™)

Study Details

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.

Conditions

PARKINSON DISEASE (Disorder)

Study ID

NCT07798271

Start date

May 8, 2026

Status verified date

Aug, 2026

Completion date

Jul 1, 2032

Anticipated

Primary completion date

Jul 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: aDBS-Extended

Adaptive DBS 1 - Extended (aDBS-Extended): neural signal biomarkers and thresholds established through an extended optimization protocol that integrates in-clinic and at-home recordings across multiple medication states. Participants receive this condition for 1 week per block, repeated 8 times over \~6 months in randomized crossover with the other two conditions.

active comparator: aDBS-Standard

Adaptive DBS 2 - Standard (aDBS-Standard): neural signal biomarkers and thresholds optimized during short, limited programming sessions, consistent with Medtronic's recommended clinical procedure. Participants receive this condition for 1 week per block, repeated 8 times over \~6 months in randomized crossover with the other two conditions.

active comparator: Continuous DBS (cDBS) - Active Control

Continuous DBS (cDBS, active control): constant amplitude at the participant's stable clinical setting. Biomarker and frequency band parameters will be recorded but will not modulate stimulation. Participants receive this condition for 1 week per block, repeated 8 times over \~6 months in randomized crossover with the other two conditions.

Interventions

aDBS-Extended (Medtronic Percept™)

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™)

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™)

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.

Primary outcome measure

  • Prevalence and Spectral Properties of STN Local Field Potential Peaks [ Time Frame: Neural recordings obtained during 1 in-clinic session. For participants in Part 2, selected neural biomarker will be recorded for 14 days, and symptom and medication logs completed on 3 of those days. Events are recorded for predefined symptoms. ]
  • Percent Time With Most Bothersome Motor Symptom [ Time Frame: Daily assessment over each 1-week treatment block; repeated 8 times per condition over approximately 6 months. ]
  • Severity of Most Bothersome Motor Symptom [ Time Frame: Daily assessment over each 1-week treatment block; repeated 8 times per condition over approximately 6 months ]
  • Quality of Life (EQ-5D-5L) [ Time Frame: Daily assessment over each 1-week treatment block; repeated 8 times per condition over approximately 6 months ]

Central Contacts and Locations

Central contacts

Annie K Abay, B.S.

408-728-0148akabay@health.ucdavis.edu

Locations

UC Davis Center for Neuroscience

Recruiting

Davis, California, United States, 95618

Contacts

Annie K Abay

408-728-0148akabay@health.ucdavis.edu

More Information

Sponsor

University of California, Davis

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Motor Fluctuations
  • Adaptive Deep Brain Stimulation
  • Closed-Loop Deep Brain Stimulation
  • Basal Ganglia
  • Parkinson Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-09-01.