Udall Project 2 Aim 2A&C

Recruiting

• Conditions: Parkinson Disease
• Interventions: Other: observational-- no intervention

• Registration Number: NCT05656586
• Lead Sponsor: University of Minnesota

Brief Summary

This protocol will leverage the novel (on-label, FDA-approved) local field potential measuring capability of the Medtronic Percept™ PC DBS system to study the effects of globus pallidus internus and globus pallidus externus (GPi, GPe) 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 4 weeks). These experiments will elucidate the relationships between GP LFPs oscillations, lower limb function, postural control and gait performance.

Detailed Description

This protocol will leverage the novel (on-label, FDA-approved) local field potential measuring capability of the Medtronic Percept™ PC DBS system to study the effects of globus pallidus internus and globus pallidus externus (GPi, GPe) 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 4 weeks). These experiments will elucidate the relationships between GP LFPs oscillations, lower limb function, postural control and gait performance.

Study Timeline

• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-19
• Study Start: 2023-01-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• Primary Completion: 2026-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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

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 UBACC)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	observational-- no intervention	Inclusion criteria for all aims/experiments * 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

Primary Outcome Measures

Name	Time	Method
Stride length	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)
Peak negative power	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).
Alpha power during standardized daily gait assessment	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	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)

Secondary Outcome Measures

Name	Time	Method
step length variability	30 days	The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.
time spent away from home	30 days	time spent away from home, as measured by the mPower smartphone app
alpha power immediately following freezing of gait episodes, falls and other major events	30 days	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
stride time variability	30 days	The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.
gait speed	30 days	The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.
distance traveled from home	30 days	distance traveled away from home, as measured by the mPower smartphone app
Peak power of local field potential oscillations	30 days	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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States