Parkinson Disease
Conditions
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.
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
observational
Sponsors
Study design
Eligibility
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak negative power | 30 day | A servo-controlled ankle manipulandum will be used to obtain objective measures of resistance about the dorsiflexion/plantar flexion axis (range of motion approximately 5 deg. dorsiflexion to 30 deg. plantar flexion; frequency = 1.5 Hz). Two conditions will be tested: passive movement with and without an activation maneuver on the contralateral side (repetitive tapping of the toe or heel). |
| Stride length | 30 days | The spatial and temporal parameters of overground steady-state gait will be assessed in the lab or derived from the wearable device (mPower) |
| Alpha power during standardized daily gait assessment | 30 days | The participant will use their DBS device patient programmer to record a time stamp and capture LFPs using the implanted Medtronic Percept™ device during the standardized daily gait assessments. |
| cadence | 30 days | The spatial and temporal parameters of overground steady-state gait will be assessed in the lab or derived from the wearable device (mPower) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| gait speed | 30 days | The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway. |
| time spent away from home | 30 days | time spent away from home, as measured by the mPower smartphone app |
| distance traveled from home | 30 days | distance traveled away from home, as measured by the mPower smartphone app |
| alpha power immediately following freezing of gait episodes, falls and other major events | 30 days | The participant will use their DBS device patent programmer to record a time stamp when they experience a freezing of gait episode and LFPs will be recorded immediately following that time by the implanted Medtronic Percept™ device |
| Peak power of local field potential oscillations | 30 days | average daytime peak alpha and beta power derived from power spectral density analysis of the local field potential signal recorded by the implanted Medtronic Percept™ device |
| stride time variability | 30 days | The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway. |
| step length variability | 30 days | The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway. |
Countries
United States