Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-loop deep brain stimulation | Active Comparator | Participants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving open-loop deep brain stimulation. |
|
| Adaptive deep brain stimulation (ramp-up) | Active Comparator | Participants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving increased stimulation in-response to gait-behavior biomarker. |
|
| Adaptive deep brain stimulation (ramp-down) | Active Comparator | Participants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving decreased stimulation in-response to gait-behavior biomarker. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percept RC | Device | Using the Percept RC pulse generator, patients receive clinically-optimized open loop stimulation to the pallidum/subthalmaic nucleus. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freezing of gait | Freezing of gait episodes will be detected using validated home wearable devices along with participant self-reporting. | Baseline and 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Ability to give informed consent for the study
Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria
Patient has requested surgical intervention with deep brain stimulation for their disorder
No magnetic resonance (MR) abnormalities that suggest an alternative diagnosis or contraindicate surgery
Absence of significant cognitive impairment (score of 21 or greater on the Montreal Cognitive Assessment (MoCA)),
Signed informed consent
Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment.
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 including freezing of gait off medication.
Ability of patient and/or caregivers to recharge the system evaluated by all clinicians and study personnel.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Doris D Wang, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
In a small, double-blinded trial, the investigators will compare the effects of aDBS versus conventional open-loop DBS on gait. Participants will be randomized to either open-loop DBS or different aDBS conditions (10 days per condition, with counterbalancing the order of stimulation within subject and randomizing this counterbalanced order across subjects). Participants will be perform gait tasks at home along with doing their everyday activities with a wearable device that tracks gait metrics and FOG episodes. Gait and balance measurements, external wearable data collection, and UPDRS III will be performed at the end of the 10-day stimulation period for each condition in-person.
Not provided
Not provided
Not provided
|
| Percept RC | Device | Using the Percept RC pulse generator, patients receive increased adaptive stimulation to the pallidum/subthalmaic nucleus. |
|
|
| Percept RC | Device | Using the Percept RC pulse generator, patients receive decreased adaptive stimulation to the pallidum/subthalmaic nucleus. |
|
|
| 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | Baseline and 2 years |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |