Udall Project 2 Aim 2A&C

NCT ID: NCT05656586

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2027-03-01

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

observational-- no intervention

Intervention Type OTHER

observational

Interventions

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observational-- no intervention

observational

Intervention Type OTHER

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Colum Mackinnon, PhD

Role: CONTACT

612-625-8938

Facility Contacts

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Johanna Caskey

Role: primary

763-353-9470

Other Identifiers

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STUDY00016988

Identifier Type: -

Identifier Source: org_study_id

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