What this study is
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.
What's being tested
- Summit RC+S
Intervention · DEVICE
Participants receive gait-optimized stimulation settings while walking and Parkinson's disease symptom-optimized settings during non-walking periods.
- Summit RC+S
Intervention · DEVICE
Participants receive clinically-optimized open-loop deep brain stimulation ot the pallidum.
Study details
- Official title
- Movement State-Dependent Adaptive Deep Brain Stimulation for Parkinson's Disease
- Sponsor
- Doris Wang, MD, PhD
- Conditions
- Parkinson's Disease (PD)
- Enrolling
- 6 people
- Starts
- 2026-02-04
- Est. completion
- 2030-04-01
- Design
- Double-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join if
- Inability to comply with study procedures
- Patients who cannot walk (wheelchair bound)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUCSF
San Francisco, California, United States
Study team
Sponsor
Doris Wang, MD, PhD
Study ID 25-45335
Principal investigator
Doris Wang, MD, PhD
University of California, San Francisco
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.