PARKINSON DISEASE (Disorder)OPT-aDBSNCT07798271
Optimizing Adaptive DBS for Parkinson's Disease
A study testing aDBS-Extended (Medtronic Percept™) and aDBS-Standard (Medtronic Percept™) in people with PARKINSON DISEASE (Disorder), run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- aDBS-Extended (Medtronic Percept™) and aDBS-Standard (Medtronic Percept™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2026to 1 Jul 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC Davis Center for Neuroscience
Davis, California, 95618
Annie K Abay, 408-728-0148, akabay@health.ucdavis.edu
About this study
Official title: Optimizing Adaptive Deep Brain Stimulation for Parkinson's Disease
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.
Read more
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.
Read the detailed description
Adaptive deep brain stimulation (aDBS) automatically adjusts stimulation based on brain activity recorded by an implanted deep brain stimulation (DBS) system. Current clinical programming of aDBS relies on recordings of brain activity collected during brief clinic visits. However, Parkinson's disease symptoms and the underlying brain activity fluctuate throughout the day in response to medication, daily activities and other factors. It is unknown whether recordings collected during routine clinic visits adequately capture the brain signals needed to optimize adaptive DBS for everyday life.
Commercially available sensing-enabled DBS systems now allow chronic recording of brain activity during everyday life. These recordings provide an opportunity to characterize patient-specific brain signals under real-world conditions and determine whether incorporating this information improves adaptive DBS programming and clinical outcomes.
This study addresses two primary questions:
- Does more comprehensive in-clinic characterization of brain signals across medication states improve adaptive DBS programming compared with the current clinic-based approach?
- Does incorporating chronic at-home recordings of brain activity further improve adaptive DBS programming and clinical outcomes?
The study consists of two sequential parts.
Part 1: Brain signal characterization and adaptive DBS programming
All enrolled participants will undergo comprehensive in-clinic testing across medication and stimulation states using a commercially available sensing-enabled DBS system. Brain activity will subsequently be recorded during everyday life using the device's chronic sensing capabilities together with participant-reported symptoms. These data will be used to identify patient-specific brain signals associated with medication state and motor symptoms and to develop individualized, data-driven adaptive DBS settings. Participants with brain signals that track their motor symptoms will be eligible for Part 2.
Part 2: Randomized crossover comparison of adaptive DBS programming strategies
Eligible participants will enter a randomized, blinded, within-subject crossover study comparing three stimulation approaches:
- Conventional DBS with a fixed amplitude (cDBS)
- Adaptive DBS programmed using the current clinic-based optimization procedure (aDBS-Standard)
- Adaptive DBS programmed using an extended optimization procedure that combines comprehensive in-clinic characterization with chronic at-home recordings of brain activity (aDBS-Extended)
During the crossover phase, participants will wear a smartwatch to continuously monitor motor function and complete daily symptom and quality-of-life assessments using a smartphone application while continuing their usual daily activities. These measures will be used to compare the three stimulation approaches under real-world conditions.
This study will determine whether incorporating comprehensive in-clinic characterization and chronic at-home recordings of brain activity into adaptive DBS programming improves clinical outcomes compared with current programming methods. It will also characterize the prevalence and clinical relevance of brain signals used for adaptive DBS and provide information to guide future programming strategies for Parkinson's disease.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- aDBS-Extended (Medtronic Percept™), aDBS-Standard (Medtronic Percept™), Continuous DBS (cDBS) - Active Control (Medtronic Percept™)
- Keywords
- Motor Fluctuations, Adaptive Deep Brain Stimulation, Closed-Loop Deep Brain Stimulation, Basal Ganglia, Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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-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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Continuous DBS (cDBS) - Active Control (Medtronic Percept™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Subthalamic nucleus (STN) local field potential spectral power will be compared between ON- and OFF-medication states using cluster-based permutation testing across frequencies. Data will be pooled across movement and rest conditions and across two stimulation levels to identify medication-related spectral differences that are independent of movement state and stimulation level. For significant frequency clusters, the magnitude of the medication-related difference will be quantified using Cohen's d. The frequency or frequency range with the largest Cohen's d will be selected as the patient-specific neural biomarker for subsequent at-home analyses.
Measured: During the in-clinic testing session
Wearable-Derived Motor Symptoms Across DBS Conditions
During testing of the DBS algorithms, the effect on motor symptoms will be objectively assessed using a validated wrist-worn movement sensor during each treatment condition. A single wearable-derived motor measure will be selected for each participant based on their predefined most bothersome motor symptom (bradykinesia, dyskinesia, or tremor). Tremor, bradykinesia, and dyskinesia are quantified using validated proprietary algorithm-derived scores (reported in device-defined score units) calculated for consecutive 2-minute epochs. Differences in the selected wearable-derived motor measure across conventional DBS, standard adaptive DBS, and extended adaptive DBS will be evaluated at the group level using a linear mixed-effects model, with participant included as a random effect.
Measured: 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
The patient-specific subthalamic nucleus (STN) neural biomarker identified during in-clinic testing will be recorded during daily life together with motor symptoms objectively assessed using a validated wrist-worn movement sensor. Tremor, bradykinesia, and dyskinesia are quantified using validated proprietary algorithm-derived scores (reported in device-defined score units) calculated for consecutive 2-minute epochs. Regression analyses will quantify the relationships between patient-specific STN neural biomarker activity and wearable-derived measures of tremor, bradykinesia, and dyskinesia, with the regression coefficients reported as the outcomes.
Measured: At-home neural and wearable recordings over 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start8 May 2026
- Primary completion1 Jul 2032 (estimated)
- Study completion1 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carina Renate Oehrn, University of California, Davis
- Investigators
- Carina Oehrn, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798271
- Sponsor's protocol ID
- 2354739
- Acronym
- OPT-aDBS
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified neural and behavioral data may be shared with qualified collaborators at other institutions.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Adaptive Deep Brain Stimulation for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07798271
- Acronym / sponsor ID
- OPT-aDBS / 2354739
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- Motor Fluctuations, Adaptive Deep Brain Stimulation, Closed-Loop Deep Brain Stimulation, Basal Ganglia, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 8 May 2026 (actual)
- Primary completion
- 1 Jul 2032 (estimated)
- Study completion
- 1 Jul 2032 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adaptive deep brain stimulation (aDBS) automatically adjusts stimulation based on brain activity recorded by an implanted deep brain stimulation (DBS) system. Current clinical programming of aDBS relies on recordings of brain activity collected during brief clinic visits. However, Parkinson's disease symptoms and the underlying brain activity fluctuate throughout the day in response to medication, daily activities and other factors. It is unknown whether recordings collected during routine clinic visits adequately capture the brain signals needed to optimize adaptive DBS for everyday life.
Commercially available sensing-enabled DBS systems now allow chronic recording of brain activity during everyday life. These recordings provide an opportunity to characterize patient-specific brain signals under real-world conditions and determine whether incorporating this information improves adaptive DBS programming and clinical outcomes.
This study addresses two primary questions:
- Does more comprehensive in-clinic characterization of brain signals across medication states improve adaptive DBS programming compared with the current clinic-based approach?
- Does incorporating chronic at-home recordings of brain activity further improve adaptive DBS programming and clinical outcomes?
The study consists of two sequential parts.
Part 1: Brain signal characterization and adaptive DBS programming
All enrolled participants will undergo comprehensive in-clinic testing across medication and stimulation states using a commercially available sensing-enabled DBS system. Brain activity will subsequently be recorded during everyday life using the device's chronic sensing capabilities together with participant-reported symptoms. These data will be used to identify patient-specific brain signals associated with medication state and motor symptoms and to develop individualized, data-driven adaptive DBS settings. Participants with brain signals that track their motor symptoms will be eligible for Part 2.
Part 2: Randomized crossover comparison of adaptive DBS programming strategies
Eligible participants will enter a randomized, blinded, within-subject crossover study comparing three stimulation approaches:
- Conventional DBS with a fixed amplitude (cDBS)
- Adaptive DBS programmed using the current clinic-based optimization procedure (aDBS-Standard)
- Adaptive DBS programmed using an extended optimization procedure that combines comprehensive in-clinic characterization with chronic at-home recordings of brain activity (aDBS-Extended)
During the crossover phase, participants will wear a smartwatch to continuously monitor motor function and complete daily symptom and quality-of-life assessments using a smartphone application while continuing their usual daily activities. These measures will be used to compare the three stimulation approaches under real-world conditions.
This study will determine whether incorporating comprehensive in-clinic characterization and chronic at-home recordings of brain activity into adaptive DBS programming improves clinical outcomes compared with current programming methods. It will also characterize the prevalence and clinical relevance of brain signals used for adaptive DBS and provide information to guide future programming strategies for Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aDBS-Extended | Experimental | Device: aDBS-Extended (Medtronic Percept™)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. |
| aDBS-Standard | Active comparator | Device: aDBS-Standard (Medtronic Percept™)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. |
| Continuous DBS (cDBS) - Active Control | Active comparator | Device: Continuous DBS (cDBS) - Active Control (Medtronic Percept™)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | aDBS-Extended |
| 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. | Device | aDBS-Standard |
| 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. | Device | Continuous DBS (cDBS) - Active Control |
Primary outcome
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.
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.
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.
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).
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
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.
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
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.
3 secondary outcomes
Medication-Related Modulation of STN Local Field Potential Spectral Power
Time frame: During the in-clinic testing session
Wearable-Derived Motor Symptoms Across DBS Conditions
Time frame: 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
Time frame: At-home neural and wearable recordings over 14 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified neural and behavioral data may be shared with qualified collaborators at other institutions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carina Oehrn, MD, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aDBS-Extended (Medtronic Percept™) and aDBS-Standard (Medtronic Percept™) in people with PARKINSON DISEASE (Disorder), run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annie K Abay, B.S. (408-728-0148, akabay@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.