NCT05656586 · University of Minnesota
Udall Project 2 Aim 2A&C
What this study is about
This protocol will leverage the novel (on-label, FDA-approved) local field potential measuring capability of the Medtronic Percept™ PC or RC DBS system to study the effects of globus pallidus internus, globus pallidus externus (GPi, GPe), and subthalamic nucleus (STN) DBS on: the wash-out and wash-in dynamics of motor behavior and local field potentials (LFPs) and correlations between fluctuations in gait and LFPs during activities of daily living (recorded over a minimum of 4 weeks). These experiments will elucidate the relationships between LFPs oscillations, lower limb function, postural control and gait performance.
View original scientific description
This protocol will leverage the novel (on-label, FDA-approved) local field potential measuring capability of the Medtronic Percept™ PC or RC DBS system to study the effects of globus pallidus internus, globus pallidus externus (GPi, GPe), and subthalamic nucleus (STN) DBS on: the wash-out and wash-in dynamics of motor behavior and local field potentials (LFPs) and correlations between fluctuations in gait and LFPs during activities of daily living (recorded over a minimum of 4 weeks). These experiments will elucidate the relationships between LFPs oscillations, lower limb function, postural control and gait performance.
Interventions
OTHER
observational-- no intervention
observational
Primary outcome measures
Peak negative power
Time frame: 30 day
A servo-controlled ankle manipulandum will be used to obtain objective measures of resistance about the dorsiflexion/plantar flexion axis (range of motion approximately 5 deg. dorsiflexion to 30 deg. plantar flexion; frequency = 1.5 Hz). Two conditions will be tested: passive movement with and without an activation maneuver on the contralateral side (repetitive tapping of the toe or heel).
Stride length
Time frame: 30 days
The spatial and temporal parameters of overground steady-state gait will be assessed in the lab or derived from the wearable device (mPower)
Alpha power during standardized daily gait assessment
Time frame: 30 days
The participant will use their DBS device patient programmer to record a time stamp and capture LFPs using the implanted Medtronic Percept™ device during the standardized daily gait assessments.
cadence
Time frame: 30 days
The spatial and temporal parameters of overground steady-state gait will be assessed in the lab or derived from the wearable device (mPower)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Receiving DBS therapy in GP for treatment of PD
- Implanted with Medtronic Percept DBS system
- At least 3 months since initial activation of the neurostimulator
- For the "At Home" experiment only: participants with DBS settings that are sensing compatible.
Exclusion criteria
- history of musculoskeletal disorders that significantly affects the ability to perform the motor tasks in the specific experiment in question
- history of dementia or cognitive impairment
- other significant neurological disorder as determined by the PI
- post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment
- lack of capacity to consent (as identified by MaCAT-CR)
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 3, 2026 · Source of record for eligibility and locations