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Parkinson's Disease (PD)NCT07424508

Movement State-dependent Adaptive DBS for PD

A study testing Summit RC+S in people with Parkinson's Disease (PD), run by Doris Wang, MD, PhD at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Parkinson's Disease (PD)
What is being tested?
Summit RC+S
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
4 Feb 2026to 1 Apr 2030
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
  • 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
Show all 9Show fewer
  • 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.

Who cannot join

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

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
  • UCSF

    San Francisco, California, 94134

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Summit RC+S
Keywords
neuromodulation, closed-loop deep brain stimulation, gait impairments, motor learning, parkinson's 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.

  • Summit RC+SDevice

    Participants receive gait-optimized stimulation settings while walking and Parkinson's disease symptom-optimized settings during non-walking periods.

  • Summit RC+SDevice

    Participants receive clinically-optimized open-loop deep brain stimulation ot the pallidum.

Study groups in NCT07424508
Study groupRoleWhat they receive
Continuous (open-loop) deep brain stimulationActive comparatorParkinson's disease patients implanted with Summit RC+S and brain lead implanted in the pallidal/striatal region receiving open-loop deep brain stimulation.
Receives: Device: Summit RC+S
Movement state-dependent adaptive (closed-loop) deep brain stimulationActive comparatorParkinson'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.
Receives: Device: Summit RC+S

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Mini Balance Evaluation Systems Test (Mini-BESTest) Scores

    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.

    Measured: after each 7 day block

  2. Change in Gait

    Change in gait measurements using the wearable devices (i.e., ankle wristband Rover and STAT-ON Holter)

    Measured: 14 day long-term testing period

  3. Change in Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III scores

    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.

    Measured: after each 7 day block

  4. Change in Stride Length

    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.

    Measured: 14 day long-term testing period

  5. Change in Stride Time

    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.

    Measured: 14 day long-term testing period

  6. Change in Double Support Time

    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).

    Measured: 14 day long-term testing period

  7. Change in number of freezes

    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).

    Measured: 14 day long-term testing period

  8. Change in number of falls

    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).

    Measured: 14 day long-term testing period

  9. Change in Activities-Specific Balance Confidence (ABC) Scale

    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.

    Measured: once per day during 14 day long-term testing period

Secondary outcomes (2)
  1. Change in Montreal Cognitive Assessment (MoCA) scores

    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.

    Measured: after each 7 day block

  2. Changes in Parkinson's Disease (PD) Symptoms Questionnaire

    Changes in responses to a questionnaire that collects information about PD symptoms, balance, walking, falls, and freezing of gait.

    Measured: once per day during 14 day long-term testing period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2026
  2. Study start4 Feb 2026
  3. Primary completion1 Apr 2030 (estimated)
  4. Study completion1 Apr 2030 (estimated)

Resources

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
Model description
In a small, double-blinded trial, the investigators will compare the overall efficacy of closed-loop and open-loop paradigms in terms of behavioral performance improvements in subject-reported metrics and validated measurements from wearable devices. During the long-term movement state-dependent adaptive DBS (aDBS) phase, aDBS and open-loop constant 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. At the end of each 7-day block, the research team will administer clinical tests, including the Montreal Cognitive Assessment (MoCA), Unified Parkinson's Disease Rating Scale (UPDRS) III, and the Mini Balance Evaluation Systems Test (Mini-BESTest).
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07424508
Sponsor's protocol ID
25-45335
Status last verified
Feb 2026
First submitted
13 Feb 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Little S, Pogosyan A, Neal S, Zavala B, Zrinzo L, Hariz M, Foltynie T, Limousin P, Ashkan K, FitzGerald J, Green AL, Aziz TZ, Brown P. Adaptive deep brain stimulation in advanced Parkinson disease. Ann Neurol. 2013 Sep;74(3):449-57. doi: 10.1002/ana.23951. Epub 2013 Jul 12.

    PubMed 23852650
  • Wang D, Ramesh R, Azgomi HF, Louie K, Balakid J, Marks J. At-Home Movement State Classification Using Totally Implantable Bidirectional Cortical-Basal Ganglia Neural Interface. Res Sq [Preprint]. 2025 Mar 12:rs.3.rs-6058394. doi: 10.21203/rs.3.rs-6058394/v1.

    PubMed 40162212
  • Azgomi HF, Louie KH, Bath JE, Presbrey KN, Balakid JP, Marks JH, Wozny TA, Galifianakis NB, Luciano MS, Little S, Starr PA, Wang DD. Modeling and Optimizing Deep Brain Stimulation to Enhance Gait in Parkinson's Disease: Personalized Treatment with Neurophysiological Insights. medRxiv [Preprint]. 2024 Nov 1:2024.10.30.24316305. doi: 10.1101/2024.10.30.24316305.

    PubMed 39574845

Questions about this trial

What is this clinical trial studying?

A study testing Summit RC+S in people with Parkinson's Disease (PD), 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 9 inclusion and 2 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 13 Oct 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?

Change in Mini Balance Evaluation Systems Test (Mini-BESTest) Scores (time frame: after each 7 day block). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07424508, which also lists 3 linked publications.

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 13 Oct 2026.

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