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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: observational-- no intervention

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 36

Contacts and Locations

• Study Contact: Name: Colum Mackinnon, PhD; Phone Number: 612-625-8938; Email: cmackinn@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Contact: Johanna Caskey; Phone Number: 763-353-9470; Email: caske039@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• 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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: observational-- no intervention; observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
gait speed	The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.	30 days
time spent away from home	time spent away from home, as measured by the mPower smartphone app	30 days
distance traveled from home	distance traveled away from home, as measured by the mPower smartphone app	30 days
alpha power immediately following freezing of gait episodes, falls and other major events	The participant will use their DBS device patent programmer to record a time stamp when they experience a freezing of gait episode and LFPs will be recorded immediately following that time by the implanted Medtronic Percept™ device	30 days
Peak power of local field potential oscillations	average daytime peak alpha and beta power derived from power spectral density analysis of the local field potential signal recorded by the implanted Medtronic Percept™ device	30 days
stride time variability	The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.	30 days
step length variability	The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
gait asymmetry	The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.	30 days

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: STUDY00016988

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No