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Udall Project 2 Aim 2A&C

NCT05656586 · University of Minnesota
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Official title
Mechanisms and Effects of Pallidal Deep Brain Stimulation on Levodopa Resistant Motor Signs in Parkinson's Disease; Udall Project 2 Aim 2A&C
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.
Eligibility criteria
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 design
Enrollment target: 36 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2023-01-01
Estimated completion: 2028-03-01
Last updated: 2026-03-03
Interventions
Other: observational-- no intervention
Primary outcomes
  • Peak negative power (30 day)
  • Stride length (30 days)
  • Alpha power during standardized daily gait assessment (30 days)
Sponsor
University of Minnesota · other
Contacts & investigators
ContactColum Mackinnon, PhD · contact · cmackinn@umn.edu · 612-625-8938
All locations (1)
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Udall Project 2 Aim 2A&C · TrialPath