Parkinson DiseaseNCT06998303
Imaging Core Aim 2, and Udall Project 2 Aim 2
A study testing Bipolar DBS stimulation in people with Parkinson Disease, run by University of Minnesota at 1 site in United States.
Trial summary
More than one million people in the United States have Parkinson's disease (PD) and the prevalence is expected to double by 2040. Over 60% of these individuals will develop debilitating postural instability and gait disturbances (PIGD), including freezing of gait (FOG). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Bipolar DBS stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 31 Jul 2027
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 and up
- Implanted with MR-compatible DBS device (Medtronic Percept/Percept RC DBS System) for treatment of Parkinson's disease
- English speaking
Who cannot join
- Unable to consent for themselves
- Implanted with a DBS device that is not MR compatible
- Pregnant
- Extreme claustrophobia
- Any contraindications for MRI
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
Sarah Bedell, sbedell@umn.edu
About this study
More than one million people in the United States have Parkinson's disease (PD) and the prevalence is expected to double by 2040. Over 60% of these individuals will develop debilitating postural instability and gait disturbances (PIGD), including freezing of gait (FOG). With disease progression, axial motor symptoms typically become resistant to dopamine replacement therapies (e.g. levodopa) and a primary source of disability and morbidity. While subthalamic (STN) and globus pallidus internus (GPi) deep brain stimulation (DBS) using standard locations and stimulation parameters can be highly effective for the treatment of the cardinalmotorsymptomsof PD, both treatments often fail to control levodopa-resistant motor features of PD such as PIGD. DBS can also impair cognitive function which further exacerbates PIGD, particularly when the task requires attentional resources. Thus, despite considerable improvements in appendicular bradykinesia, rigidity and tremor with conventional DBS, the disease can continue to be dominated by PIGD, leading to increased falls, decreased mobility, and increased rate of hospitalization and morbidity. This is why one of the top NINDS priorities for clinical research in PD is the development of novel therapeutic approaches, such as DBS targeting, to treat levodopa-resistant motor symptoms.
This study will provide crucial information to elucidate the functional properties of the networks involved in Deep Brain Stimulation (DBS) treatment. By refining our understanding of the neural networks involved in stimulation of DBS targets, we will improve our ability to program patients to enhance their clinical outcomes and minimize side effects.
- Conditions
- Parkinson Disease
- Being tested
- Bipolar DBS stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar DBS stimulationOther
All participants will receive bipolar DBS through stimulation contacts 3 (most dorsal GP contact) and contact 2 (adjacent to contact 3) as specified by the device manufacturer. Bipolar stimulation through contacts 3 and 2 may be different from the settings used by the participant for optimal clinical improvement, as determined by their DBS care provider
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 2 Study Procedures: Patients who have been already implanted with a MRI compatible DBS device (Medtronic Percept / Percept RC™) Receives: Other: Bipolar DBS stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Oxygen-Level Dependent (BOLD) signal in leg region of primary motor cortex
Data will be obtained from functional MRI scanning with the participant at rest, with DBS cycling between ON and OFF stimulation.
The change in BOLD signal in the leg region of the primary motor cortex will be obtained by contrasting signals obtained during ON vs. OFF stimulation states.
The change in BOLD signal represents the increase/decrease in brain activity in the leg region related to stimulation.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Apr 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (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.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm study in which all participants will receive the same study interventions
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noam Harel, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998303
- Sponsor's protocol ID
- Udall 2
- Status last verified
- May 2026
- First submitted
- 14 Apr 2025
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Core Aim 2, and Udall Project 2 Aim 2
- ClinicalTrials.gov ID
- NCT06998303
- Acronym / sponsor ID
- Udall 2
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 31 May 2025 (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.
More than one million people in the United States have Parkinson's disease (PD) and the prevalence is expected to double by 2040. Over 60% of these individuals will develop debilitating postural instability and gait disturbances (PIGD), including freezing of gait (FOG). With disease progression, axial motor symptoms typically become resistant to dopamine replacement therapies (e.g. levodopa) and a primary source of disability and morbidity. While subthalamic (STN) and globus pallidus internus (GPi) deep brain stimulation (DBS) using standard locations and stimulation parameters can be highly effective for the treatment of the cardinalmotorsymptomsof PD, both treatments often fail to control levodopa-resistant motor features of PD such as PIGD. DBS can also impair cognitive function which further exacerbates PIGD, particularly when the task requires attentional resources. Thus, despite considerable improvements in appendicular bradykinesia, rigidity and tremor with conventional DBS, the disease can continue to be dominated by PIGD, leading to increased falls, decreased mobility, and increased rate of hospitalization and morbidity. This is why one of the top NINDS priorities for clinical research in PD is the development of novel therapeutic approaches, such as DBS targeting, to treat levodopa-resistant motor symptoms.
This study will provide crucial information to elucidate the functional properties of the networks involved in Deep Brain Stimulation (DBS) treatment. By refining our understanding of the neural networks involved in stimulation of DBS targets, we will improve our ability to program patients to enhance their clinical outcomes and minimize side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm study in which all participants will receive the same study interventions
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Bipolar DBS stimulation2 Study Procedures: Patients who have been already implanted with a MRI compatible DBS device (Medtronic Percept / Percept RC™) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 21 and up
- Implanted with MR-compatible DBS device (Medtronic Percept/Percept RC DBS System) for treatment of Parkinson's disease
- English speaking
Key exclusion criteria (5 listed)
- Unable to consent for themselves
- Implanted with a DBS device that is not MR compatible
- Pregnant
- Extreme claustrophobia
- Any contraindications for MRI
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 |
|---|---|---|
| Bipolar DBS stimulationAll participants will receive bipolar DBS through stimulation contacts 3 (most dorsal GP contact) and contact 2 (adjacent to contact 3) as specified by the device manufacturer. Bipolar stimulation through contacts 3 and 2 may be different from the settings used by the participant for optimal clinical improvement, as determined by their DBS care provider | Other | Study group |
Primary outcome
Change in Blood Oxygen-Level Dependent (BOLD) signal in leg region of primary motor cortex
Time frame: 8 hours
Data will be obtained from functional MRI scanning with the participant at rest, with DBS cycling between ON and OFF stimulation. The change in BOLD signal in the leg region of the primary motor cortex will be obtained by contrasting signals obtained during ON vs. OFF stimulation states. The change in BOLD signal represents the increase/decrease in brain activity in the leg region related to stimulation.
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 29 May 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.
Noam Harel, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar DBS stimulation in people with 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 3 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 29 May 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 Sarah Bedell (612-625-5396, sbedell@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Oxygen-Level Dependent (BOLD) signal in leg region of primary motor cortex (time frame: 8 hours). 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 29 May 2026; AzTrials last refreshed its copy on 3 Nov 2026.