Parkinsons DiseaseNCT05568199
Udall Project 1 Aim 4
An observational study of Parkinsons Disease and Deep Brain Stimulation, run by University of Minnesota at 1 site in United States.
Trial summary
By defining the strength and direction of connectivity patterns at rest and during movement across the basal ganglia-thalamocortical (BGTC) network we will characterize the role of individual circuits in motor performance and cognitive function, paving the way for future development of optimization algorithms for DBS… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Parkinsons Disease, Deep Brain Stimulation
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2024to 1 Mar 2027
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential participants are identified by clinicians and trained research personnel through the movement disorder clinic. Patients are identified during the University of Minnesota DBS surgery candidacy evaluation process.
Who may be able to join
- Implanted with a DBS system
- Existing 7T imagery (either done as standard-of-care or done as part of Noam Harel's study, IRB #1210M22183)
- Diagnosed with idiopathic Parkinson's Disease
- Minimum age 21 years
Who cannot join
- Other significant neurological disorder, as determined by PI
- Diagnosis of dementia
- Pregnant
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, 55455
About this study
By defining the strength and direction of connectivity patterns at rest and during movement across the basal ganglia-thalamocortical (BGTC) network we will characterize the role of individual circuits in motor performance and cognitive function, paving the way for future development of optimization algorithms for DBS that take advantage of this understanding.
- Conditions
- Parkinsons Disease, Deep Brain 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients will make one visit to the M Health Clinical Research Unit (CRU) after overnight withdrawal of PD medications (still on-DBS) and undergo motor and cognitive assessments in the following three conditions: 1. clinically-optimized stimulation 2. model-based stimulation directed towards motor subregions of STN and GPi 3. model-based stimulation directed towards associative/limbic subregions of STN/GPi Randomized to start with condition1 assessment | |
| Group 2 | Patients will make one visit to the M Health Clinical Research Unit (CRU) after overnight withdrawal of PD medications (still on-DBS) and undergo motor and cognitive assessments in the following three conditions: 1. clinically-optimized stimulation 2. model-based stimulation directed towards motor subregions of STN and GPi 3. model-based stimulation directed towards associative/limbic subregions of STN/GPi Randomized to start with condition 2 assessment | |
| Group 3 | Patients will make one visit to the M Health Clinical Research Unit (CRU) after overnight withdrawal of PD medications (still on-DBS) and undergo motor and cognitive assessments in the following three conditions: 1. clinically-optimized stimulation 2. model-based stimulation directed towards motor subregions of STN and GPi 3. model-based stimulation directed towards associative/limbic subregions of STN/GPi Randomized to start with condition 3 assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor association with pathway activation patterns
associate pathway activation patterns with motor (UPDRS-III) outcome obtained during standard of care and research appointments.
Measured: 6 months post surgery
Cognitive outcome 1 association with pathway activation pattern
associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments.
One primary cognitive outcome measure will be the D-KEFS Letter Fluency test. Another primary cognitive measure will be the Stroop Color Word total score. Secondary measures will include the Beck Depression Inventory (BDI)-II and Apathy Scale total scores.
Measured: 6 months post surgery
Cognitive outcome 2 association with pathway activation pattern
associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments.
cognitive measure will be the Stroop Color Word total score.
Measured: 6 months post surgery
Cognitive outcome 3 association with pathway activation pattern
associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments.
cognitive measure will include the Beck Depression Inventory (BDI)-II
Measured: 6 months post surgery
Cognitive outcome 4 association with pathway activation pattern
associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments.
cognitive measure will include the Apathy Scale total scores.
Measured: 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start5 Mar 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsons 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerrold Vitek, MD, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568199
- Sponsor's protocol ID
- STUDY00007781
- Status last verified
- Apr 2026
- First submitted
- 26 Sep 2022
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Udall Project 1 Aim 4
- ClinicalTrials.gov ID
- NCT05568199
- Acronym / sponsor ID
- STUDY00007781
- Conditions
- Parkinsons Disease, Deep Brain Stimulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 5 Oct 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.
By defining the strength and direction of connectivity patterns at rest and during movement across the basal ganglia-thalamocortical (BGTC) network we will characterize the role of individual circuits in motor performance and cognitive function, paving the way for future development of optimization algorithms for DBS that take advantage of this understanding.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients will make one visit to the M Health Clinical Research Unit (CRU) after overnight withdrawal of PD medications (still on-DBS) and undergo motor and cognitive assessments in the following three conditions: 1. clinically-optimized stimulation 2. model-based stimulation directed towards motor subregions of STN and GPi 3. model-based stimulation directed towards associative/limbic subregions of STN/GPi Randomized to start with condition1 assessment |
| Group 2 | – | –Patients will make one visit to the M Health Clinical Research Unit (CRU) after overnight withdrawal of PD medications (still on-DBS) and undergo motor and cognitive assessments in the following three conditions: 1. clinically-optimized stimulation 2. model-based stimulation directed towards motor subregions of STN and GPi 3. model-based stimulation directed towards associative/limbic subregions of STN/GPi Randomized to start with condition 2 assessment |
| Group 3 | – | –Patients will make one visit to the M Health Clinical Research Unit (CRU) after overnight withdrawal of PD medications (still on-DBS) and undergo motor and cognitive assessments in the following three conditions: 1. clinically-optimized stimulation 2. model-based stimulation directed towards motor subregions of STN and GPi 3. model-based stimulation directed towards associative/limbic subregions of STN/GPi Randomized to start with condition 3 assessment |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential participants are identified by clinicians and trained research personnel through the movement disorder clinic. Patients are identified during the University of Minnesota DBS surgery candidacy evaluation process.
Key inclusion criteria (4 listed)
- Implanted with a DBS system
- Existing 7T imagery (either done as standard-of-care or done as part of Noam Harel's study, IRB #1210M22183)
- Diagnosed with idiopathic Parkinson's Disease
- Minimum age 21 years
Key exclusion criteria (3 listed)
- Other significant neurological disorder, as determined by PI
- Diagnosis of dementia
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Motor association with pathway activation patterns
Time frame: 6 months post surgery
associate pathway activation patterns with motor (UPDRS-III) outcome obtained during standard of care and research appointments.
Cognitive outcome 1 association with pathway activation pattern
Time frame: 6 months post surgery
associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments. One primary cognitive outcome measure will be the D-KEFS Letter Fluency test. Another primary cognitive measure will be the Stroop Color Word total score. Secondary measures will include the Beck Depression Inventory (BDI)-II and Apathy Scale total scores.
Cognitive outcome 2 association with pathway activation pattern
Time frame: 6 months post surgery
associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments. cognitive measure will be the Stroop Color Word total score.
Cognitive outcome 3 association with pathway activation pattern
Time frame: 6 months post surgery
associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments. cognitive measure will include the Beck Depression Inventory (BDI)-II
Cognitive outcome 4 association with pathway activation pattern
Time frame: 6 months post surgery
associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments. cognitive measure will include the Apathy Scale total scores.
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 8 Apr 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.
Jerrold Vitek, MD, 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?
An observational study of Parkinsons Disease and Deep Brain Stimulation, 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 3 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 8 Apr 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 Niecy Beltz (612-626-5711, beltz070@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor association with pathway activation patterns (time frame: 6 months post surgery). The study lists 5 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 8 Apr 2026.