Udall Project 2 Aim 2A&C
Recruiting · NCT05656586 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Minnesota
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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)
Where it is running
1 location listed across 1 US state.
- University of Minnesota - Minneapolis, Minnesota, United States