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NCT05656586 | RECRUITING | Parkinson Disease

Udall Project 2 Aim 2A&C
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 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.

Condition or disease

Parkinson Disease

Intervention/treatment

observational-- no intervention

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 36 participants
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
Actual Study Start Date : 2023-01-01
Estimated Primary Completion Date : 2027-03-01
Estimated Study Completion Date : 2028-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
Udall Project 2 Aim 2A&C

Location Details

NCT05656586

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How to Participate

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Locations

RECRUITING

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55414