Adaptive Deep Brain Stimulation for Freezing of Gait in Parkinson's Disease

April 27, 2026 updated by: Doris Wang, MD, PhD

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The main questions it aims to answer are:

  1. Does adaptive DBS lead to fewer freezing of gait episodes for participants compared to their clinical continuous DBS settings?
  2. 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:

  1. Measure their walking using at-home monitoring devices (worn on the hip or ankles) while on their clinical continuous DBS settings.
  2. Visit the lab for check-ins and testing of adaptive DBS settings.
  3. Try different adaptive DBS settings at home, while wearing at-home monitoring devices.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ability to give informed consent for the study
  2. 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
  3. Patient has requested surgical intervention with deep brain stimulation for their disorder
  4. No magnetic resonance (MR) abnormalities that suggest an alternative diagnosis or contraindicate surgery
  5. Absence of significant cognitive impairment (score of 21 or greater on the Montreal Cognitive Assessment (MoCA)),
  6. Signed informed consent
  7. Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment.
  8. Age 21-75
  9. Diagnosis of idiopathic PD with duration of motor symptoms for 3 years or greater
  10. Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist.

  11. 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

  12. Patients with gait impairments including freezing of gait off medication.
  13. Ability of patient and/or caregivers to recharge the system evaluated by all clinicians and study personnel.

Exclusion Criteria:

  1. 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
  2. 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.
  3. Pregnancy: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
  4. Significant untreated depression (BDI-II score >20). History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS)
  5. Any personality or mood symptoms that study personnel believe will interfere with study requirements.
  6. Subjects who require Electroconvulsive therapy (ECT), Repetitive Transcranial Magnetic Stimulation (rTMS) or diathermy
  7. Implanted stimulation systems such as cochlear implant, pacemaker, defibrillator, or neurostimulator
  8. Previous cranial surgery
  9. Drug or alcohol abuse
  10. 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.
  11. Known allergies to the implantable device components including titanium, polyurethane, silicone, and nylon.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open-loop deep brain stimulation
Participants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving open-loop deep brain stimulation.
Device: Percept RC
Using the Percept RC pulse generator, patients receive clinically-optimized open loop stimulation to the pallidum/subthalmaic nucleus.
Other Names:
  • Continuous deep brain stimulation
Device: Percept RC
Using the Percept RC pulse generator, patients receive increased adaptive stimulation to the pallidum/subthalmaic nucleus.
Other Names:
  • Adaptive deep brain stimulation
Device: Percept RC
Using the Percept RC pulse generator, patients receive decreased adaptive stimulation to the pallidum/subthalmaic nucleus.
Other Names:
  • Adaptive deep brain stimulation
Active Comparator: Adaptive deep brain stimulation (ramp-up)
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.
Device: Percept RC
Using the Percept RC pulse generator, patients receive clinically-optimized open loop stimulation to the pallidum/subthalmaic nucleus.
Other Names:
  • Continuous deep brain stimulation
Device: Percept RC
Using the Percept RC pulse generator, patients receive increased adaptive stimulation to the pallidum/subthalmaic nucleus.
Other Names:
  • Adaptive deep brain stimulation
Device: Percept RC
Using the Percept RC pulse generator, patients receive decreased adaptive stimulation to the pallidum/subthalmaic nucleus.
Other Names:
  • Adaptive deep brain stimulation
Active Comparator: Adaptive deep brain stimulation (ramp-down)
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.
Device: Percept RC
Using the Percept RC pulse generator, patients receive clinically-optimized open loop stimulation to the pallidum/subthalmaic nucleus.
Other Names:
  • Continuous deep brain stimulation
Device: Percept RC
Using the Percept RC pulse generator, patients receive increased adaptive stimulation to the pallidum/subthalmaic nucleus.
Other Names:
  • Adaptive deep brain stimulation
Device: Percept RC
Using the Percept RC pulse generator, patients receive decreased adaptive stimulation to the pallidum/subthalmaic nucleus.
Other Names:
  • Adaptive deep brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gait
Time Frame: Baseline and 2 years
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.
Baseline and 2 years
Change in MDS-UPDRS III scores
Time Frame: Baseline and 2 years
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.
Baseline and 2 years
Change in Balance
Time Frame: Baseline and 2 years

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.
Baseline and 2 years
Change in Stride Length
Time Frame: Baseline and 2 years
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.
Baseline and 2 years
Change in Stride Time
Time Frame: Baseline and 2 years
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.
Baseline and 2 years
Change in Arm Swing Amplitude
Time Frame: Baseline and 2 years
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.
Baseline and 2 years
Change in Gait Symmetry
Time Frame: Baseline and 2 years
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).
Baseline and 2 years
Change in Gait Variance
Time Frame: Baseline and 2 years
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).
Baseline and 2 years
Change in Total Electrical Energy Delivered (TEED)
Time Frame: Baseline and 2 years
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.
Baseline and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Doris Wang, MD, PhD

Investigators

  • Principal Investigator: Doris D Wang, MD, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-43493

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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