Parkinson DiseaseNCT06819020
Adaptive Deep Brain Stimulation for Freezing of Gait in Parkinson's Disease
A study testing Percept RC in people with Parkinson Disease, run by Doris Wang, MD, PhD at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if adaptive deep brain stimulation (DBS) can decrease or prevent freezing of gait in participants with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Percept RC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2026to 1 Aug 2029
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to give informed consent for the study
- Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria
- Patient has requested surgical intervention with deep brain stimulation for their disorder
- No magnetic resonance (MR) abnormalities that suggest an alternative diagnosis or contraindicate surgery
- Absence of significant cognitive impairment (score of 21 or greater on the Montreal Cognitive Assessment (MoCA)),
- Signed informed consent
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- Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment.
- Age 21-75
- Diagnosis of idiopathic PD with duration of motor symptoms for 3 years or greater
- Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist.
- UPDRS-III score off medication between 20 and 80 and an improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score, and motor fluctuations with at least 2 hours per day of on time without dyskinesia or with non-bothersome dyskinesia.
- OR Patients with tremor-dominant PD (a tremor score of at least 2 on a UPDRS-III sub-score for tremor), treatment resistant, with significant functional disability despite maximal medical management
- Patients with gait impairments including freezing of gait off medication.
- Ability of patient and/or caregivers to recharge the system evaluated by all clinicians and study personnel.
Who cannot join
- Coagulopathy, anticoagulant medications, uncontrolled hypertension, history of seizures, heart disease, or other medical conditions considered to place the patient at elevated risk for surgical complications
- Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion or "while unobserved", symptoms that are inconsistent over time or incongruent with clinical condition, plus other manifestation such as "false" signs, multiple somatizations, or obvious psychiatric disturbance.
- Pregnancy: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
- Significant untreated depression (BDI-II score >20). History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS)
- Any personality or mood symptoms that study personnel believe will interfere with study requirements.
- Subjects who require Electroconvulsive therapy (ECT), Repetitive Transcranial Magnetic Stimulation (rTMS) or diathermy
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- Implanted stimulation systems such as cochlear implant, pacemaker, defibrillator, or neurostimulator
- Previous cranial surgery
- Drug or alcohol abuse
- Meets criteria for Parkinson's disease with mild cognitive impairment (PD-MCI). These criteria are performance of more than two standard deviations below appropriate norms, for tests from two or more of these five cognitive domains: attention, executive function, language, memory, and visuospatial tests.
- Known allergies to the implantable device components including titanium, polyurethane, silicone, and nylon.
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
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Adaptive Deep Brain Stimulation to Improve Freezing of Gait in Parkinson's Disease Using Percept RC
The goal of this clinical trial is to learn if adaptive deep brain stimulation (DBS) can decrease or prevent freezing of gait in participants with Parkinson's disease.
Read the detailed description
The main questions it aims to answer are:
- Does adaptive DBS lead to fewer freezing of gait episodes for participants compared to their clinical continuous DBS settings?
- Does adaptive DBS change other parts of participants' walking, like step length, step time, or step symmetry?
Investigators will compare personalized adaptive DBS settings for each participant with their continuous DBS settings to see if adaptive DBS works better to treat gait symptoms, including freezing of gait.
Participants will have DBS insertion surgery as part of their standard medical care. Along with the DBS system, they will also have permanent sensors placed between their skull and scalp to detect brain activity related to movement. After, participants will:
- Measure their walking using at-home monitoring devices (worn on the hip or ankles) while on their clinical continuous DBS settings.
- Visit the lab for check-ins and testing of adaptive DBS settings.
- Try different adaptive DBS settings at home, while wearing at-home monitoring devices.
- Conditions
- Parkinson Disease
- Being tested
- Percept RC
- Keywords
- Neuromodulation, Deep Brain Stimulation, Freezing of Gait, Adaptive DBS, Gait Impairment, 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.
Percept RCDevice
Also called Continuous deep brain stimulation
Using the Percept RC pulse generator, patients receive clinically-optimized open loop stimulation to the pallidum/subthalmaic nucleus.
Percept RCDevice
Also called Adaptive deep brain stimulation
Using the Percept RC pulse generator, patients receive increased adaptive stimulation to the pallidum/subthalmaic nucleus.
Percept RCDevice
Also called Adaptive deep brain stimulation
Using the Percept RC pulse generator, patients receive decreased adaptive stimulation to the pallidum/subthalmaic nucleus.
| Study group | Role | What they receive |
|---|---|---|
| Open-loop deep brain stimulation | Active comparator | Participants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving open-loop deep brain stimulation. Receives: Device: Percept RC |
| Adaptive deep brain stimulation (ramp-up) | Active comparator | Participants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving increased stimulation in-response to gait-behavior biomarker. Receives: Device: Percept RC |
| Adaptive deep brain stimulation (ramp-down) | Active comparator | Participants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving decreased stimulation in-response to gait-behavior biomarker. Receives: Device: Percept RC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freezing of gait
Freezing of gait episodes will be detected using validated home wearable devices along with participant self-reporting.
Measured: Baseline and 2 years
Secondary outcomes (9)
Change in Gait
Change in gait measurements using the 10-meter walk timed test. The 10-Meter Walk Test (10MWT) is a performance measure used to assess walking speed in meters per second over a short distance of 10 meters. It is employed to determine functional mobility and gait. The gait speed is used as the outcome by which to compare change in performance capacity. Lower times indicate higher levels of physical functioning.
Measured: Baseline and 2 years
Change in Balance
Change in balance measurements using:
Mini-BESTest Clinical balance assessment tool. The score range is 0-2 with high score indicating higher levels of physical functioning.
Measured: Baseline and 2 years
Change in MDS-UPDRS III scores
Change in Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) III score. The scale consists of 18 items that are each scored 0 to 3, making the total score out of 72 points, with higher scores indicating higher impairment.
Measured: Baseline and 2 years
Change in Stride Length
Change in stride length measured by Rover (a gait measurement device), Xsens (a kinematic measurement device), and Stat-On (a gait measurement device), with adaptive compared to open-loop deep brain stimulation (DBS). Stride length is measured in meters.
Measured: Baseline and 2 years
Change in Stride Time
Change in stride time measured by Rover (a gait measurement device), Xsens (a kinematic measurement device), and Stat-On (a gait measurement device) with adaptive compared to open-loop deep brain stimulation (DBS). Stride time is measured in seconds.
Measured: Baseline and 2 years
Change in Arm Swing Amplitude
Change in arm swing ampliture measured Xsens (a kinematic measurement device) with adaptive compared to open-loop deep brain stimulation (DBS). Arm swing amplitude is measured in meters.
Measured: Baseline and 2 years
Change in Gait Symmetry
Change in gait symmetry measured by Rover (a gait measurement device), Xsens (a kinematic measurement device), and Stat-On (a gait measurement device), with adaptive compared to open-loop deep brain stimulation (DBS).
Measured: Baseline and 2 years
Change in Gait Variance
Change in gait variance measured by Rover (a gait measurement device), Xsens (a kinematic measurement device), and Stat-On (a gait measurement device), with adaptive compared to open-loop deep brain stimulation (DBS).
Measured: Baseline and 2 years
Change in Total Electrical Energy Delivered (TEED)
Change in TEED calculated using voltage, frequency, pulse width, and impedence values from participant pulse generators, with adaptive compared to open-loop deep brain stimulation (DBS). TEED is measured in microjoules.
Measured: Baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start31 Jan 2026
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- In a small, double-blinded trial, the investigators will compare the effects of aDBS versus conventional open-loop DBS on gait. Participants will be randomized to either open-loop DBS or different aDBS conditions (10 days per condition, with counterbalancing the order of stimulation within subject and randomizing this counterbalanced order across subjects). Participants will be perform gait tasks at home along with doing their everyday activities with a wearable device that tracks gait metrics and FOG episodes. Gait and balance measurements, external wearable data collection, and UPDRS III will be performed at the end of the 10-day stimulation period for each condition in-person.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Doris Wang, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Doris Wang, MD, PhD, University of California, San Francisco
- Investigators
- Doris D Wang, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819020
- Sponsor's protocol ID
- 25-43493
- Status last verified
- Oct 2025
- First submitted
- 5 Feb 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Deep Brain Stimulation to Improve Freezing of Gait in Parkinson's Disease Using Percept RC
- ClinicalTrials.gov ID
- NCT06819020
- Acronym / sponsor ID
- 25-43493
- Conditions
- Parkinson Disease
- Keywords
- Neuromodulation, Deep Brain Stimulation, Freezing of Gait, Adaptive DBS, Gait Impairment, Parkinson disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Doris Wang, MD, PhDUniversity, hospital or other
- Study start
- 31 Jan 2026 (actual)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 11 Feb 2025 (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.
The goal of this clinical trial is to learn if adaptive deep brain stimulation (DBS) can decrease or prevent freezing of gait in participants with Parkinson's disease.
Detailed description
The main questions it aims to answer are:
- Does adaptive DBS lead to fewer freezing of gait episodes for participants compared to their clinical continuous DBS settings?
- Does adaptive DBS change other parts of participants' walking, like step length, step time, or step symmetry?
Investigators will compare personalized adaptive DBS settings for each participant with their continuous DBS settings to see if adaptive DBS works better to treat gait symptoms, including freezing of gait.
Participants will have DBS insertion surgery as part of their standard medical care. Along with the DBS system, they will also have permanent sensors placed between their skull and scalp to detect brain activity related to movement. After, participants will:
- Measure their walking using at-home monitoring devices (worn on the hip or ankles) while on their clinical continuous DBS settings.
- Visit the lab for check-ins and testing of adaptive DBS settings.
- Try different adaptive DBS settings at home, while wearing at-home monitoring devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- In a small, double-blinded trial, the investigators will compare the effects of aDBS versus conventional open-loop DBS on gait. Participants will be randomized to either open-loop DBS or different aDBS conditions (10 days per condition, with counterbalancing the order of stimulation within subject and randomizing this counterbalanced order across subjects). Participants will be perform gait tasks at home along with doing their everyday activities with a wearable device that tracks gait metrics and FOG episodes. Gait and balance measurements, external wearable data collection, and UPDRS III will be performed at the end of the 10-day stimulation period for each condition in-person.
| Arm | Type | Receives |
|---|---|---|
| Open-loop deep brain stimulation | Active comparator | Device: Percept RCParticipants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving open-loop deep brain stimulation. |
| Adaptive deep brain stimulation (ramp-up) | Active comparator | Device: Percept RCParticipants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving increased stimulation in-response to gait-behavior biomarker. |
| Adaptive deep brain stimulation (ramp-down) | Active comparator | Device: Percept RCParticipants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving decreased stimulation in-response to gait-behavior biomarker. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Ability to give informed consent for the study
- Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria
- Patient has requested surgical intervention with deep brain stimulation for their disorder
- No magnetic resonance (MR) abnormalities that suggest an alternative diagnosis or contraindicate surgery
- Absence of significant cognitive impairment (score of 21 or greater on the Montreal Cognitive Assessment (MoCA)),
Key exclusion criteria (11 listed)
- Coagulopathy, anticoagulant medications, uncontrolled hypertension, history of seizures, heart disease, or other medical conditions considered to place the patient at elevated risk for surgical complications
- Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion or "while unobserved", symptoms that are inconsistent over time or incongruent with clinical condition, plus other manifestation such as "false" signs, multiple somatizations, or obvious psychiatric disturbance.
- Pregnancy: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
- Significant untreated depression (BDI-II score >20). History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS)
- Any personality or mood symptoms that study personnel believe will interfere with study requirements.
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 |
|---|---|---|
| Percept RCAlso: Continuous deep brain stimulationUsing the Percept RC pulse generator, patients receive clinically-optimized open loop stimulation to the pallidum/subthalmaic nucleus. | Device | Open-loop deep brain stimulation |
| Percept RCAlso: Adaptive deep brain stimulationUsing the Percept RC pulse generator, patients receive increased adaptive stimulation to the pallidum/subthalmaic nucleus. | Device | Adaptive deep brain stimulation (ramp-up) |
| Percept RCAlso: Adaptive deep brain stimulationUsing the Percept RC pulse generator, patients receive decreased adaptive stimulation to the pallidum/subthalmaic nucleus. | Device | Adaptive deep brain stimulation (ramp-down) |
Primary outcome
Freezing of gait
Time frame: Baseline and 2 years
Freezing of gait episodes will be detected using validated home wearable devices along with participant self-reporting.
9 secondary outcomes
Change in Gait
Time frame: Baseline and 2 years
Change in Balance
Time frame: Baseline and 2 years
Change in MDS-UPDRS III scores
Time frame: Baseline and 2 years
Change in Stride Length
Time frame: Baseline and 2 years
Change in Stride Time
Time frame: Baseline and 2 years
Change in Arm Swing Amplitude
Time frame: Baseline and 2 years
Change in Gait Symmetry
Time frame: Baseline and 2 years
Change in Gait Variance
Time frame: Baseline and 2 years
Change in Total Electrical Energy Delivered (TEED)
Time frame: Baseline and 2 years
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 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Doris D Wang, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percept RC in people with Parkinson Disease, run by Doris Wang, MD, PhD 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 14 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 29 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freezing of gait (time frame: Baseline and 2 years). 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 29 Apr 2026.