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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05656586
Enrollment
36
Registered
2022-12-19
Start date
2023-01-01
Completion date
2028-03-01
Last updated
2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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.

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.

Interventions

OTHERobservational-- no intervention

observational

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Peak negative power30 dayA 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 length30 daysThe 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 assessment30 daysThe 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.
cadence30 daysThe spatial and temporal parameters of overground steady-state gait will be assessed in the lab or derived from the wearable device (mPower)

Secondary

MeasureTime frameDescription
gait speed30 daysThe spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.
time spent away from home30 daystime spent away from home, as measured by the mPower smartphone app
distance traveled from home30 daysdistance traveled away from home, as measured by the mPower smartphone app
alpha power immediately following freezing of gait episodes, falls and other major events30 daysThe 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
Peak power of local field potential oscillations30 daysaverage 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
stride time variability30 daysThe spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.
step length variability30 daysThe spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.

Countries

United States

Contacts

CONTACTColum Mackinnon, PhD
cmackinn@umn.edu612-625-8938

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026