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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Using the Percept RC pulse generator, patients receive clinically-optimized open loop stimulation to the pallidum/subthalmaic nucleus.
Using the Percept RC pulse generator, patients receive increased adaptive stimulation to the pallidum/subthalmaic nucleus.
Using the Percept RC pulse generator, patients receive decreased adaptive stimulation to the pallidum/subthalmaic nucleus.
University of California, San Francisco
San Francisco, California, United States
Freezing of gait
Freezing of gait episodes will be detected using validated home wearable devices along with participant self-reporting.
Time frame: Baseline and 2 years
Change in Gait
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.
Time frame: Baseline and 2 years
Change in Balance
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.
Time frame: Baseline and 2 years
Change in MDS-UPDRS III scores
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.
Time frame: Baseline and 2 years
Change in Stride Length
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.
Time frame: Baseline and 2 years
Change in Stride Time
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.
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Time frame: Baseline and 2 years
Change in Arm Swing Amplitude
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.
Time frame: Baseline and 2 years
Change in Gait Symmetry
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).
Time frame: Baseline and 2 years
Change in Gait Variance
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).
Time frame: Baseline and 2 years
Change in Total Electrical Energy Delivered (TEED)
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.
Time frame: Baseline and 2 years