Clinical trial NCT05656586: Udall Project 2 Aim 2A&C
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 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

Brief summary: This protocol will leverage the novel (on-label, FDA-approved) local field potential measuring capability of the Medtronic Percept™ PC DBS system to study the effects of globus pallidus internus and globus pallidus externus (GPi, GPe) 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 4 weeks). These experiments will elucidate the relationships between GP LFPs oscillations, lower limb function, postural control and gait performance.

Detailed description: This protocol will leverage the novel (on-label, FDA-approved) local field potential measuring capability of the Medtronic Percept™ PC DBS system to study the effects of globus pallidus internus and globus pallidus externus (GPi, GPe) 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 4 weeks). These experiments will elucidate the relationships between GP 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

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 UBACC)

Primary outcomes:
measure: Peak negative power
timeFrame: 30 day
measure: Stride length
timeFrame: 30 days
measure: Alpha power during standardized daily gait assessment
timeFrame: 30 days
measure: cadence
timeFrame: 30 days
Secondary outcomes:
measure: gait speed
timeFrame: 30 days
measure: time spent away from home
timeFrame: 30 days
measure: distance traveled from home
timeFrame: 30 days
measure: alpha power immediately following freezing of gait episodes, falls and other major events
timeFrame: 30 days
measure: Peak power of local field potential oscillations
timeFrame: 30 days
measure: stride time variability
timeFrame: 30 days
measure: step length variability
timeFrame: 30 days
Other outcomes:
measure: gait asymmetry
timeFrame: 30 days
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: