Optimizing Adaptive DBS for Parkinson's Disease

NCT07798271 | Recruiting FDA Device

• 1 other identifier: 2354739
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Prevalence and Spectral Properties of STN Local Field Potential Peaks

  Prevalence and spectral properties of STN local field potential (LFP) peaks (beta: 13-30 Hz; gamma: 60-90 Hz), and their modulation by dopaminergic medication state.

  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

  Percent time of the most bothersome motor symptom, assessed via electronic self-ratings (Oehrn et al., Nature Medicine, 2024). Primary outcome measures will be derived from nightly self-reports, including time spent with the most bothersome motor symptom (hours/day) and time awake (hours/day). The outcome is calculated as the percentage of waking hours spent with the most bothersome motor symptom (hours with symptom ÷ waking hours × 100).

  Daily assessment over each 1-week treatment block; repeated 8 times per condition over approximately 6 months.

• Severity of Most Bothersome Motor Symptom

  Self-reported severity of the most bothersome motor symptom. Symptom severity (0-10 scale). Scores range from 0 (no symptoms) to 10 (worst possible symptoms); higher scores indicate worse outcome.

  Daily assessment over each 1-week treatment block; repeated 8 times per condition over approximately 6 months

• Quality of Life (EQ-5D-5L)

  Quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), including the EQ Visual Analogue Scale (EQ VAS; range 0-100), with higher scores indicating better perceived health.

  Daily assessment over each 1-week treatment block; repeated 8 times per condition over approximately 6 months

Secondary Outcomes (3)

• Medication-Related Modulation of STN Local Field Potential Spectral Power

  During the in-clinic testing session

• Wearable-Derived Motor Symptoms Across DBS Conditions

  Continuous wearable monitoring during each 1-week treatment block, repeated 8 times per condition over approximately 6 months.

• Regression of Wearable-Derived Motor Measures on Patient-Specific STN Neural Biomarker Activity

  At-home neural and wearable recordings over 14 days.

Study Arms (3)

aDBS-Extended

EXPERIMENTAL

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.

Device: aDBS-Extended (Medtronic Percept™)

aDBS-Standard

ACTIVE COMPARATOR

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.

Device: aDBS-Standard (Medtronic Percept™)

Continuous DBS (cDBS) - Active Control

ACTIVE COMPARATOR

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.

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

Interventions

aDBS-Extended (Medtronic Percept™) 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-Extended

aDBS-Standard (Medtronic Percept™) 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.

aDBS-Standard

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

Continuous DBS (cDBS) - Active Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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)

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Center for Neuroscience

Davis, California, 95618, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Carina Oehrn, MD, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annie K Abay, B.S.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome raters are blinded to the stimulation condition. The unblinded programmer is responsible for setting up device groups. cDBS control uses a "sham adaptive" active control setting - all parameters will be configured to appear as if an adaptive algorithm is active, but stimulation amplitude will remain fixed at the standard cDBS level. This ensures the program appears as an adaptive option on the patient programmer while maintaining blinding.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurological Surgery

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: September 1, 2026
• Study Start: May 8, 2026
• Primary Completion (Estimated): July 1, 2032
• Study Completion (Estimated): July 1, 2032
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)