Udall Project 2 Aim 2A&C

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05656586
• Other study ID #: STUDY00016988
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: March 1, 2027

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: Colum Mackinnon, PhD
• Phone: 612-625-8938
• Email: cmackinn[@]umn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• observational-- no intervention
observational

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	gait asymmetry	The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.	30 days
Primary	Peak negative power	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).	30 day
Primary	Stride length	The spatial and temporal parameters of overground steady-state gait will be assessed in the lab or derived from the wearable device (mPower)	30 days
Primary	Alpha power during standardized daily gait assessment	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.	30 days
Primary	cadence	The spatial and temporal parameters of overground steady-state gait will be assessed in the lab or derived from the wearable device (mPower)	30 days
Secondary	gait speed	The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.	30 days
Secondary	time spent away from home	time spent away from home, as measured by the mPower smartphone app	30 days
Secondary	distance traveled from home	distance traveled away from home, as measured by the mPower smartphone app	30 days
Secondary	alpha power immediately following freezing of gait episodes, falls and other major events	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	30 days
Secondary	Peak power of local field potential oscillations	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	30 days
Secondary	stride time variability	The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.	30 days
Secondary	step length variability	The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.	30 days