Parkinson DiseaseNCT05656586
Udall Project 2 Aim 2A&C
An observational study of Parkinson Disease, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Johanna Caskey, 763-353-9470, caske039@umn.edu
About this study
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
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- observational-- no intervention
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational-- no interventionOther
observational
| Study group | Role | What they receive |
|---|---|---|
| Participants | 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 Receives: Other: observational-- no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 day
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)
Measured: 30 days
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.
Measured: 30 days
cadence
The spatial and temporal parameters of overground steady-state gait will be assessed in the lab or derived from the wearable device (mPower)
Measured: 30 days
Secondary outcomes (7)
gait speed
The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.
Measured: 30 days
time spent away from home
time spent away from home, as measured by the mPower smartphone app
Measured: 30 days
distance traveled from home
distance traveled away from home, as measured by the mPower smartphone app
Measured: 30 days
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
Measured: 30 days
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
Measured: 30 days
stride time variability
The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.
Measured: 30 days
step length variability
The spatial and temporal parameters of steady-state gait will be assessed using a computerized walkway.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Jan 2023
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656586
- Sponsor's protocol ID
- STUDY00016988
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2022
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05656586
- Acronym / sponsor ID
- STUDY00016988
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: observational-- no interventionInclusion 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational-- no interventionobservational | Other | Participants |
Primary outcome
Peak negative power
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colum Mackinnon, PhD (612-625-8938, cmackinn@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak negative power (time frame: 30 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.