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NCT Number: NCT05656586

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Johanna Caskey

CONTACT

[email protected]

763-353-9470

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

observational-- no intervention

Other

observational

Primary outcomes

  1. 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).

  2. 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)

  3. 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.

  4. 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)

Secondary outcomes

  1. gait speed

    Time frame: 30 days

    The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.

  2. time spent away from home

    Time frame: 30 days

    time spent away from home, as measured by the mPower smartphone app

  3. distance traveled from home

    Time frame: 30 days

    distance traveled away from home, as measured by the mPower smartphone app

  4. alpha power immediately following freezing of gait episodes, falls and other major events

    Time frame: 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

  5. Peak power of local field potential oscillations

    Time frame: 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

  6. stride time variability

    Time frame: 30 days

    The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.

  7. step length variability

    Time frame: 30 days

    The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.

Other outcomes

  1. gait asymmetry

    Time frame: 30 days

    The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.

Study contacts

Contact information is provided by the study sponsor or research team.

Colum Mackinnon, PhD

CONTACT

[email protected]

612-625-8938

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Mechanisms and Effects of Pallidal Deep Brain Stimulation on Levodopa Resistant Motor Signs in Parkinson's Disease; Udall Project 2 Aim 2A&C

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Dec 19, 2022
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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