Udall Project 2 Aim 2A&C
Mechanisms and Effects of Pallidal Deep Brain Stimulation on Levodopa Resistant Motor Signs in Parkinson's Disease; Udall Project 2 Aim 2A&C
1 other identifier
observational
36
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2022
CompletedFirst Posted
Study publicly available on registry
December 19, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
March 3, 2026
February 1, 2026
4.2 years
December 5, 2022
February 27, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Peak negative power
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).
30 day
Stride length
The spatial and temporal parameters of overground steady-state gait will be assessed in the lab or derived from the wearable device (mPower)
30 days
Alpha power during standardized daily gait assessment
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.
30 days
cadence
The spatial and temporal parameters of overground steady-state gait will be assessed in the lab or derived from the wearable device (mPower)
30 days
Secondary Outcomes (7)
gait speed
30 days
time spent away from home
30 days
distance traveled from home
30 days
alpha power immediately following freezing of gait episodes, falls and other major events
30 days
Peak power of local field potential oscillations
30 days
- +2 more secondary outcomes
Other Outcomes (1)
gait asymmetry
30 days
Study Arms (1)
Participants
Inclusion criteria for all aims/experiments * Receiving DBS therapy in GP or STN for treatment of PD * Implanted with Medtronic Percept DBS system * At least 3 months since initial activation of the neurostimulator
Interventions
Eligibility 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
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55414, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2022
First Posted
December 19, 2022
Study Start
January 1, 2023
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
March 3, 2026
Record last verified: 2026-02