Movement State-dependent Adaptive DBS for PD

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

Movement State-Dependent Adaptive Deep Brain Stimulation for Parkinson's Disease

This is a single-center clinical study aiming to improve gait functions in patients with Parkinson's Disease (PD) by using adaptive neurostimulation to the pallidum. The investigators will use a bidirectional deep brain stimulation device with sensing and stimulation capabilities to 1) identify neural biomarkers to detect the onset of walking by recording neural activities from the motor cortical areas and the globus pallidus, 2) understand the impacts of changes in DBS parameters on gait kinematics and optimize setting parameters for enhancing walking performance, 3) develop a movement state-dependent adaptive deep brain stimulation (DBS) paradigm to automatically switch stimulation settings according to different movement states (i.e., walking vs non-walking). The proposed therapy will deliver personalized neurostimulation based on individual physiological biomarkers to enhance gait function in patients with PD. 6 patients with idiopathic Parkinson's disease who have already been implanted with the Medtronic Summit RC+S device will be enrolled in this study.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study will allow the investigators to evaluate the efficacy of a movement state-dependent adaptive deep brain stimulation paradigm to treat gait dysfunction in individuals with Parkinson's disease (PD).

While current DBS therapy improves the appendicular symptoms of PD, such as tremor and bradykinesia, it is less effective for advanced gait symptoms, which manifest as hypokinetic gait patterns, increased gait variability, asymmetry, and disturbed balance. These symptoms are debilitating and represent a major source of morbidity for patients with PD. Studies have suggested that while conventional high-frequency stimulation settings are good at treating appendicular symptoms, they may not be as effective for axial symptoms such as gait disorders. Modulating stimulation parameters, by using lower frequencies, for instance, has been shown to improve gait kinematics such as symmetry and rhythmicity. However, these settings are less effective for other symptoms and therefore come at the expense of appendicular symptom control. The overall objective of this study is to identify personalized electrophysiological signatures of movement state and gait-optimized stimulation parameters in PD patients to enable adaptive control algorithms that automatically switch from identified 'gait-optimized' settings during walking to 'other PD symptom-optimized' settings during non-walking.

This is a small, double-blinded trial, six patients with idiopathic PD and motor fluctuations who have already been implanted with the RC+S devices. The investigators will compare the overall efficacy of closed-loop (adaptive DBS) and open-loop (continuous clinical DBS) paradigms in terms of behavioral performance improvements. During this chronic movement state-dependent adaptive DBS phase, adaptive DBS and open-loop stimulation settings will be randomized for 7-day periods, and motor and gait-related measurements will be obtained from wearable devices that track movement kinematics. Patients will participate in daily, if possible, motor and gait tasks at home and are asked to fill out motor diary questionnaires to share their feedback from both motor and non-motor perspectives.

The investigators expect to successfully develop a prototype movement state-dependent adaptive DBS algorithm. They hypothesize that the embedded closed-loop, movement state-dependent adaptive DBS paradigm will improve gait function compared to the conventional open-loop approach, in which stimulation parameters remain constant, while maintaining the standard therapeutic benefits of DBS.

Study Type

Interventional

Enrollment (Estimated)

6

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, 94134
        • UCSF

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:

  • Ability to give informed consent for the study
  • Subjects implanted with Summit RC+S investigational DBS system.
  • Absence of significant cognitive impairment (score of 21 or greater on the Montreal Cognitive Assessment (MoCA)
  • Signed informed consent
  • 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: slowed gait, shuffling steps, postural instability, or freezing of gait off medication.

Exclusion Criteria:

  • Inability to comply with study procedures
  • Patients who cannot walk (wheelchair bound)

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous (open-loop) deep brain stimulation
Parkinson's disease patients implanted with Summit RC+S and brain lead implanted in the pallidal/striatal region receiving open-loop deep brain stimulation.
Device: Summit RC+S
Participants receive gait-optimized stimulation settings while walking and Parkinson's disease symptom-optimized settings during non-walking periods.
Device: Summit RC+S
Participants receive clinically-optimized open-loop deep brain stimulation ot the pallidum.
Active Comparator: Movement state-dependent adaptive (closed-loop) deep brain stimulation
Parkinson's disease patients implanted with Summit RC+S and brain lead implanted in the pallidal/striatal region receiving movement state-dependent adaptive (closed-loop) deep brain stimulation.
Device: Summit RC+S
Participants receive gait-optimized stimulation settings while walking and Parkinson's disease symptom-optimized settings during non-walking periods.
Device: Summit RC+S
Participants receive clinically-optimized open-loop deep brain stimulation ot the pallidum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mini Balance Evaluation Systems Test (Mini-BESTest) Scores
Time Frame: after each 7 day block
Change in Mini-BESTest scores, which is a clinical balance evaluations systems test. The score range is 0-2 with higher scores indicating higher levels of physical functioning.
after each 7 day block
Change in Gait
Time Frame: 14 day long-term testing period
Change in gait measurements using the wearable devices (i.e., ankle wristband Rover and STAT-ON Holter)
14 day long-term testing period
Change in Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III scores
Time Frame: after each 7 day block
Change in 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.
after each 7 day block
Change in Stride Length
Time Frame: 14 day long-term testing period
Change in stride length measured by Rover (a gait measurement device) and STAT-ON (a Parkinson's disease motor symptoms measurement device) with closed-loop compared to open-loop deep brain stimulation (DBS). Stride length measured in meters.
14 day long-term testing period
Change in Stride Time
Time Frame: 14 day long-term testing period
Change in stride time measured by Rover (a gait measurement device) and STAT-ON (a Parkinson's disease motor symptoms measurement device) with closed-loop compared to open-loop deep brain stimulation (DBS). Stride time measured in seconds.
14 day long-term testing period
Change in Double Support Time
Time Frame: 14 day long-term testing period
Change in stride time measured by Rover (a gait measurement device). Each gait cycle consists of two phases, where both feet are in contact with the ground, called Double Support. Double support time will be measured in seconds (i.e. amount of time both feet are in contact with the ground).
14 day long-term testing period
Change in number of freezes
Time Frame: 14 day long-term testing period
Change in number of freezes measured by STAT-ON (a Parkinson's disease motor symptoms measurement device) with closed-loop compared to open-loop deep brain stimulation (DBS).
14 day long-term testing period
Change in number of falls
Time Frame: 14 day long-term testing period
Change in number of falls measured by STAT-ON (a Parkinson's disease motor symptoms measurement device) with closed-loop compared to open-loop deep brain stimulation (DBS).
14 day long-term testing period
Change in Activities-Specific Balance Confidence (ABC) Scale
Time Frame: once per day during 14 day long-term testing period
Change in ABC Scale, which collects measures of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. The score range is 0-100 with higher scores indicating higher levels of physical functioning.
once per day during 14 day long-term testing period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Montreal Cognitive Assessment (MoCA) scores
Time Frame: after each 7 day block
Change in MoCA score. The scale consists of 30 1-point questions testing short term memory, visuospatial abilities, executive functions, attention, concentration, working memory, language, and orientation to time and place, with scores lower than 26 indicating possible cognitive impairment.
after each 7 day block
Changes in Parkinson's Disease (PD) Symptoms Questionnaire
Time Frame: once per day during 14 day long-term testing period
Changes in responses to a questionnaire that collects information about PD symptoms, balance, walking, falls, and freezing of gait.
once per day during 14 day long-term testing period

Collaborators and Investigators

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

Sponsor

Doris Wang, MD, PhD

Collaborators

Michael J. Fox Foundation for Parkinson's Research
Burroughs Wellcome

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 4, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-45335

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

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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