Udall Project 2 Aim 2A&C

University of Minnesota (UMN)

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Other: observational-- no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05656586

STUDY00016988

Details and patient eligibility

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

36 participants in 1 patient group

Participants

Description:

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

Treatment:

Other: observational-- no intervention