Parkinson DiseaseNCT06692920
Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.
A study testing DBS stimulation in people with Parkinson Disease, run by University of Minnesota at 1 site in United States.
Trial summary
When a patient gets DBS surgery, the neurosurgeon makes a hole in the skull through which they can put the DBS lead down in deep parts of the brain that help control movement. For this study, research participants will also have an ECoG strip put through the same hole (no extra holes are being made for research… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- DBS stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 1 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic PD
- DBS surgery at UMN is planned as part of routine clinical care
- Aged 21-75
Who cannot join
- Other significant neurological disorder, which may confound neurophysiological changes associated with Parkinson's disease
- History of dementia
- Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
- Pregnant women
- Known research radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy
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
Niecy Beltz, 612-626-5711, beltz070@umn.edu
About this study
When a patient gets DBS surgery, the neurosurgeon makes a hole in the skull through which they can put the DBS lead down in deep parts of the brain that help control movement. For this study, research participants will also have an ECoG strip put through the same hole (no extra holes are being made for research purposes). The ECoG strip is a little less than half an inch wide, and a little more than 2.5 inches long. It is very, very thin; it is a thin plastic film with flat metal sensors that can record the electrical activity in the brain. The ECoG strips are FDA approved. The neurosurgeon will slide the ECoG strip under the skull but on top of the brain, over another area of the brain that helps control hand/arm movement (motor cortex), so that the study team can record the activity there. The study team will record brain activity from the DBS lead and the ECoG strip simultaneously to try to understand how the brain communicates and sends information. The study team will check that the ECoG strip is in the right place by delivering a very small electrical pulse to the wrist. If the ECoG strip is in the correct location, this electrical pulse will show up on the brain activity being recorded by the sensors in the ECoG strip. Fluoroscopy (i.e. X-ray images that can be taken quickly) will also be done at the end of the surgery to help confirm the location of the ECoG strip. During fluoroscopy, an X-ray beam is used to track a contrast agent ("X-ray dye") through the body, so that the body can be seen in detail. This involves some radiation exposure for the participant, so this is described in the consent form. Patients who want to sign up for the study will not be allowed to do so if they have had other radiation exposures within the past year that would go over a safe limit when added to the amount of radiation expected from the fluoroscopy for this study.
Read the detailed description
The goal of this study is to understand the relationship between network brain activity and motor signs of Parkinson's disease, and to determine if brain activity can predict optimal locations or network pathways for stimulation. During deep brain stimulation lead placement surgery, research participants will have an FDA approved ECoG strip placed through the DBS lead burr hole over the primary motor cortex. The study team will record brain activity from the DBS lead and the ECoG strip simultaneously while the participant performs a reach-to-target motor task, to understand how different brain regions communicate and are associated with motor signs of Parkinson's disease. The study team will look for specific brain activity biomarkers hypothesized to be associated with Parkinson's disease and will then direct stimulation through the DBS lead toward regions showing those biomarkers and compare to stimulation directed to areas not showing the specified biomarkers. Neural pathways being activated by stimulation and behavioral measures of the reach task will be compared between the two stimulation conditions.
Intervention:
- Stimulation through the DBS lead contact showing the most coherence with brain activity in the motor cortex
- Stimulation through the DBS lead contact showing the least coherence with brain activity in the motor cortex
During the mapping session patients will either be asked to perform motor tasks such as finger-tapping, pronating/supinating the wrist, manipulating a joystick, or pointing to targets on a touch-sensitive, LCD positioned in front of them. Patients may also be asked to perform cognitive tasks such as maintaining items in working memory or deciding between potentially rewarding stimuli with either a joystick or a finger response pad.
- Conditions
- Parkinson Disease
- Being tested
- 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.
DBS stimulationOther
- Standard of care DBS surgery
- stimulation through the DBS lead during their DBS lead surgery, the study team will use 2 sets of stimulation settings on each participant:
- Stimulation through the DBS contact whose electrical activity is the MOST similar to the area of the brain that controls movement
- Stimulation through the DBS contact whose electrical activity is the LEAST similar to the area of the brain that controls movement
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Parkinson's patients with DBS surgery planned as part of routine clinical care Receives: Other: DBS stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of activity in the pallidothalamic pathway from stimulation, comparing the two sets of stimulation
The pallidothalamic pathway is what connects the two locations of the brain from which we are recording (GPi and motor cortex). We will also see how the two sets of stimulation made a difference in measurements of bradykinesia (slowness of movement): how long it took for the participant to get ready to move, how fast they started moving, and how long it took them to touch the startpad.
Measured: post-surgery (1 day)
The relationship (slope) between the measures of bradykinesia and total pathway activation
will be estimated via a linear mixed-effects (LME) model that considers multiple subjects and multiple observations within subject
Measured: post-surgery (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Dec 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua E Aman, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692920
- Sponsor's protocol ID
- NEURO-2016-24971
- Status last verified
- Mar 2026
- First submitted
- 13 Nov 2024
- Last updated
- 16 Mar 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT06692920
- Acronym / sponsor ID
- NEURO-2016-24971
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 18 Nov 2024 (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.
When a patient gets DBS surgery, the neurosurgeon makes a hole in the skull through which they can put the DBS lead down in deep parts of the brain that help control movement. For this study, research participants will also have an ECoG strip put through the same hole (no extra holes are being made for research purposes). The ECoG strip is a little less than half an inch wide, and a little more than 2.5 inches long. It is very, very thin; it is a thin plastic film with flat metal sensors that can record the electrical activity in the brain. The ECoG strips are FDA approved. The neurosurgeon will slide the ECoG strip under the skull but on top of the brain, over another area of the brain that helps control hand/arm movement (motor cortex), so that the study team can record the activity there. The study team will record brain activity from the DBS lead and the ECoG strip simultaneously to try to understand how the brain communicates and sends information. The study team will check that the ECoG strip is in the right place by delivering a very small electrical pulse to the wrist. If the ECoG strip is in the correct location, this electrical pulse will show up on the brain activity being recorded by the sensors in the ECoG strip. Fluoroscopy (i.e. X-ray images that can be taken quickly) will also be done at the end of the surgery to help confirm the location of the ECoG strip. During fluoroscopy, an X-ray beam is used to track a contrast agent ("X-ray dye") through the body, so that the body can be seen in detail. This involves some radiation exposure for the participant, so this is described in the consent form. Patients who want to sign up for the study will not be allowed to do so if they have had other radiation exposures within the past year that would go over a safe limit when added to the amount of radiation expected from the fluoroscopy for this study.
Detailed description
The goal of this study is to understand the relationship between network brain activity and motor signs of Parkinson's disease, and to determine if brain activity can predict optimal locations or network pathways for stimulation. During deep brain stimulation lead placement surgery, research participants will have an FDA approved ECoG strip placed through the DBS lead burr hole over the primary motor cortex. The study team will record brain activity from the DBS lead and the ECoG strip simultaneously while the participant performs a reach-to-target motor task, to understand how different brain regions communicate and are associated with motor signs of Parkinson's disease. The study team will look for specific brain activity biomarkers hypothesized to be associated with Parkinson's disease and will then direct stimulation through the DBS lead toward regions showing those biomarkers and compare to stimulation directed to areas not showing the specified biomarkers. Neural pathways being activated by stimulation and behavioral measures of the reach task will be compared between the two stimulation conditions.
Intervention:
- Stimulation through the DBS lead contact showing the most coherence with brain activity in the motor cortex
- Stimulation through the DBS lead contact showing the least coherence with brain activity in the motor cortex
During the mapping session patients will either be asked to perform motor tasks such as finger-tapping, pronating/supinating the wrist, manipulating a joystick, or pointing to targets on a touch-sensitive, LCD positioned in front of them. Patients may also be asked to perform cognitive tasks such as maintaining items in working memory or deciding between potentially rewarding stimuli with either a joystick or a finger response pad.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: DBS stimulationParkinson's patients with DBS surgery planned as part of routine clinical care |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of idiopathic PD
- DBS surgery at UMN is planned as part of routine clinical care
- Aged 21-75
Key exclusion criteria (5 listed)
- Other significant neurological disorder, which may confound neurophysiological changes associated with Parkinson's disease
- History of dementia
- Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
- Pregnant women
- Known research radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy
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 |
|---|---|---|
| DBS stimulation* Standard of care DBS surgery * stimulation through the DBS lead during their DBS lead surgery, the study team will use 2 sets of stimulation settings on each participant: 1. Stimulation through the DBS contact whose electrical activity is the MOST similar to the area of the brain that controls movement 2. Stimulation through the DBS contact whose electrical activity is the LEAST similar to the area of the brain that controls movement | Other | Study group |
Primary outcome
amount of activity in the pallidothalamic pathway from stimulation, comparing the two sets of stimulation
Time frame: post-surgery (1 day)
The pallidothalamic pathway is what connects the two locations of the brain from which we are recording (GPi and motor cortex). We will also see how the two sets of stimulation made a difference in measurements of bradykinesia (slowness of movement): how long it took for the participant to get ready to move, how fast they started moving, and how long it took them to touch the startpad.
The relationship (slope) between the measures of bradykinesia and total pathway activation
Time frame: post-surgery (1 day)
will be estimated via a linear mixed-effects (LME) model that considers multiple subjects and multiple observations within subject
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 16 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.
Joshua E Aman 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 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 16 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 Kelly Brown, RN ((612) 301-2140, ksbrown@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of activity in the pallidothalamic pathway from stimulation, comparing the two sets of stimulation (time frame: post-surgery (1 day)). The study lists 2 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 16 Mar 2026.