Udall Project 2 Aim 2A&C
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: observational-- no intervention.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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.
Interventions
- Other observational-- no intervention
observational
Primary outcome measures
- Peak negative power [Time frame: 30 day]
- Stride length [Time frame: 30 days]
- Alpha power during standardized daily gait assessment [Time frame: 30 days]
- cadence [Time frame: 30 days]
Secondary outcome measures (7)
- gait speed [Time frame: 30 days]
- time spent away from home [Time frame: 30 days]
- distance traveled from home [Time frame: 30 days]
- alpha power immediately following freezing of gait episodes, falls and other major events [Time frame: 30 days]
- Peak power of local field potential oscillations [Time frame: 30 days]
- stride time variability [Time frame: 30 days]
- step length variability [Time frame: 30 days]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT05656586 · STUDY00016988