Movement State-dependent Adaptive DBS for PD

NCT07424508 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 25-45335
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Parkinson's Disease (PD)

Keywords

neuromodulation; closed-loop deep brain stimulation; gait impairments; motor learning; parkinson's disease

Outcome Measures

Primary Outcomes (9)

• 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.

  after each 7 day block

• Change in Gait

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (2)

• Change in Montreal Cognitive Assessment (MoCA) scores

  after each 7 day block

• Changes in Parkinson's Disease (PD) Symptoms Questionnaire

  once per day during 14 day long-term testing period

Study Arms (2)

Continuous (open-loop) deep brain stimulation

ACTIVE COMPARATOR

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

Movement state-dependent adaptive (closed-loop) deep brain stimulation

ACTIVE COMPARATOR

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

Interventions

Summit RC+S DEVICE

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

Movement state-dependent adaptive (closed-loop) deep brain stimulation

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Doris Wang, MD, PhD: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator
• Burroughs Wellcome: collaborator

Study Sites (1)

UCSF

San Francisco, California, 94134, United States

Location

Related Publications (3)

• 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.

  PMID: 23852650 BACKGROUND

• 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.

  PMID: 40162212 BACKGROUND

• 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.

  PMID: 39574845 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Doris Wang, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: February 4, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)