ParkinsonNCT05286736
Neuroplasticity in Parkinson's Disease
An observational study of Parkinson and Parkinson Disease, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this project is to increase our understanding of the early state and temporal evolution of neuroplastic changes in the cortex and subthalamic nucleus (STN) of people with PD, and the relationship of these changes to the emergence and expression of PD motor and non-motor signs. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson, Parkinson Disease
- What is being tested?
- Neuroimaging and Quantitative assessments
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults diagnosed with Parkinson's Disease (early diagnosis, currently untreated) and age- and sex-matched healthy controls
Who may be able to join
- Participants with PD
- Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria
- Not receiving levodopa or dopamine agonist to treat PD (at baseline)
- Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters Healthy Controls
- Age- (+/- 3 years) and sex-matched to participants with PD
- Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters
Who cannot join
- Dementia diagnosis and/or a University of California Brief Assessment of Capacity to Consent (UBACC) score and MacCAT-CR score indicating impaired capacity to consent
- History of musculoskeletal disorders that significant affect movement of lower or upper limbs as determined at the time of enrollment
- History of bipolar disorder, post-traumatic stress disorder or major depressive disorder
- Other significant neurological disorders that may affect participation or performance in the study
- Implanted DBS or other neurosurgeries to treat PD
- Pregnancy
Show all 14Show fewer
- Additional exclusion criteria for TMS experiments (note that individuals who are excluded from the TMS experiment still have the opportunity to participate in the other data collection sessions):
- History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury
- Recent history of frequent syncope (fainting) episodes in response to blood, emotional stress, or sensory triggers.
- Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)
- Pacemaker or any implanted device
- History of surgery on blood vessels, brain, or heart
- Unexplained, recurring headaches or concussion within the last six months
- Severe hearing impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Plasticity of Motor Systems in Early Stage Parkinson's Disease
The purpose of this project is to increase our understanding of the early state and temporal evolution of neuroplastic changes in the cortex and subthalamic nucleus (STN) of people with PD, and the relationship of these changes to the emergence and expression of PD motor and non-motor signs. Neurophysiological biomarkers derived from this work may be important for the early detection and prediction of progression of disease. They can also provide the means to assess the efficacy of interventions designed to prevent or slow disease progression.
Read the detailed description
This project will use neuroimaging (7T MRI: structural, diffusion and rest-state functional MRI), from Dr. Noam Harel's protocol IRB# STUDY00008096, and non-invasive brain stimulation (TMS: PAS. SAI) techniques to quantify structural and functional changes in brain function. The TMS experiment will use a Magstim Bistimn 2002 transcranial magnetic stimulation (TMS) unit and standard figure-of-eight coil (70 mm diameter) to deliver stimulation on the surface of the scalp. Stimulation will be delivered using either a single pulse or with a paired-pulse protocol (two stimuli, through the same TMS coil at inter-stimulus intervals of 50 or 80 ms). All surface EMG signals will be pre-amplified within the sensor and sent wirelessly via blue-tooth connection to a Delsys data collection system. Quantitative assessments of motor function (gait, gait initiation, reactive balance, bradykinesia, repetitive alternating movements, rigidity, stop-signal reaction time), and neuropsychological function will used to assess behavioral status at baseline and 30-36 months later.
- Conditions
- Parkinson, Parkinson Disease
- Being tested
- Neuroimaging, Quantitative assessments
- Keywords
- Parkinson's
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroimagingDiagnostic test
This project will use neuroimaging (7T MRI: structural, diffusion and rest-state functional MRI) and non-invasive brain stimulation (TMS: PAS. SAI) techniques to quantify structural and functional changes in brain function.
Quantitative assessmentsDiagnostic test
Quantitative assessments of motor function (gait, gait initiation, reactive balance, bradykinesia, repetitive alternating movements, rigidity, stop-signal reaction time), and neuropsychological function
| Study group | Role | What they receive |
|---|---|---|
| Early (untreated) Parkinson's Disease | Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria. Receives: Diagnostic Test: Neuroimaging; Diagnostic Test: Quantitative assessments | |
| Healthy Controls | Age- and sex-matched healthy controls. Receives: Diagnostic Test: Neuroimaging; Diagnostic Test: Quantitative assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in volume of Subthalamic Nucleus
The volume of the subthalamic nucleus is assessed using MRI and reported in millimeters cubed (mm^3).
Measured: Baseline, 30-36 months
Change in fractional Anisotropy of Subthalamic Nucleus
Fractional anisotropy, measured using MRI, is a unit-less value between zero and one that describes the degree of anisotropy of water diffusion in a specified brain area. Higher values indicate a greater degree of anisotropy, while a score of zero indicates isotropic diffusion.
Measured: Baseline, 30-36 months
Change in cortico-STN Connectivity
Cortico-Subthalamic nucleus connectivity is measured using MRI and reported as a z score (unitless).
Measured: Baseline, 30-36 months
Change in paired Associative Stimulation-Motor Evoked Potential (PAS-MEP)
Motor evoked potential is measured as the amplitude of change in target muscle electrical activity following transcranial magnetic stimulation (TMS) and reported in units of millivolts (mV).
Measured: Baseline, 30-36 months
Change in Mattis Dementia Rating Scale 2 (DRS-2)
The DRS-2 consists of 24 items, rated on a scale from 0 to 6. Item scores are combined into five subscales: attention (8 items), initiation/perseveration (11 items), construction (6 items), conceptualization ( 6 items), and memory (5 items). These five subscale scores are summed to calculate a total score ranging from from 0 to 144 points, with lower scores indicating worse performance due to dementia.
Measured: Baseline, 30-36 months
Change in Rey Complex Figure and Matrix Reasoning of the Wechsler Adult Intelligence Scale - IV
Measure of visuospatial construction, memory and reasoning. Scaled score based on age norms.
Measured: Baseline, 30-36 months
Change in Stroop Color Word Test
Measure of response inhibition, selective attention and processing. Scaled score based on age norms.
Measured: Baseline, 30-36 months
Change in Wisconsin Card Sorting Test
Measures cognitive flexibility, abstract reasoning, and set-shifting. Scaled score based on age norms.
Measured: Baseline, 30-36 months
Change in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Subtest
Measures cognitive flexibility, abstract reasoning, and set-shifting. Scaled score based on age norms.
Measured: Baseline, 30-36 months
Change in Brief Visuospatial Memory Test - Revised (BVMT-R)
Measure of non-verbal (visuospatial) learning and memory abilities. Scaled score based on age norms.
Measured: Baseline, 30-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Mar 2021
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286736
- Sponsor's protocol ID
- NEUR-2019-28388
- Status last verified
- Oct 2026
- First submitted
- 17 Feb 2022
- Last updated
- 3 Nov 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 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasticity of Motor Systems in Early Stage Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05286736
- Acronym / sponsor ID
- NEUR-2019-28388
- Conditions
- Parkinson, Parkinson Disease
- Keywords
- Parkinson's
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 18 Mar 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.
The purpose of this project is to increase our understanding of the early state and temporal evolution of neuroplastic changes in the cortex and subthalamic nucleus (STN) of people with PD, and the relationship of these changes to the emergence and expression of PD motor and non-motor signs. Neurophysiological biomarkers derived from this work may be important for the early detection and prediction of progression of disease. They can also provide the means to assess the efficacy of interventions designed to prevent or slow disease progression.
Detailed description
This project will use neuroimaging (7T MRI: structural, diffusion and rest-state functional MRI), from Dr. Noam Harel's protocol IRB# STUDY00008096, and non-invasive brain stimulation (TMS: PAS. SAI) techniques to quantify structural and functional changes in brain function. The TMS experiment will use a Magstim Bistimn 2002 transcranial magnetic stimulation (TMS) unit and standard figure-of-eight coil (70 mm diameter) to deliver stimulation on the surface of the scalp. Stimulation will be delivered using either a single pulse or with a paired-pulse protocol (two stimuli, through the same TMS coil at inter-stimulus intervals of 50 or 80 ms). All surface EMG signals will be pre-amplified within the sensor and sent wirelessly via blue-tooth connection to a Delsys data collection system. Quantitative assessments of motor function (gait, gait initiation, reactive balance, bradykinesia, repetitive alternating movements, rigidity, stop-signal reaction time), and neuropsychological function will used to assess behavioral status at baseline and 30-36 months later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early (untreated) Parkinson's Disease | – | Diagnostic Test: Neuroimaging, Diagnostic Test: Quantitative assessmentsDiagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria. |
| Healthy Controls | – | Diagnostic Test: Neuroimaging, Diagnostic Test: Quantitative assessmentsAge- and sex-matched healthy controls. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with Parkinson's Disease (early diagnosis, currently untreated) and age- and sex-matched healthy controls
Key inclusion criteria (6 listed)
- Participants with PD
- Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria
- Not receiving levodopa or dopamine agonist to treat PD (at baseline)
- Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters Healthy Controls
- Age- (+/- 3 years) and sex-matched to participants with PD
Key exclusion criteria (14 listed)
- Dementia diagnosis and/or a University of California Brief Assessment of Capacity to Consent (UBACC) score and MacCAT-CR score indicating impaired capacity to consent
- History of musculoskeletal disorders that significant affect movement of lower or upper limbs as determined at the time of enrollment
- History of bipolar disorder, post-traumatic stress disorder or major depressive disorder
- Other significant neurological disorders that may affect participation or performance in the study
- Implanted DBS or other neurosurgeries to treat PD
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 |
|---|---|---|
| NeuroimagingThis project will use neuroimaging (7T MRI: structural, diffusion and rest-state functional MRI) and non-invasive brain stimulation (TMS: PAS. SAI) techniques to quantify structural and functional changes in brain function. | Diagnostic test | Early (untreated) Parkinson's Disease, Healthy Controls |
| Quantitative assessmentsQuantitative assessments of motor function (gait, gait initiation, reactive balance, bradykinesia, repetitive alternating movements, rigidity, stop-signal reaction time), and neuropsychological function | Diagnostic test | Early (untreated) Parkinson's Disease, Healthy Controls |
Primary outcome
Change in volume of Subthalamic Nucleus
Time frame: Baseline, 30-36 months
The volume of the subthalamic nucleus is assessed using MRI and reported in millimeters cubed (mm^3).
Change in fractional Anisotropy of Subthalamic Nucleus
Time frame: Baseline, 30-36 months
Fractional anisotropy, measured using MRI, is a unit-less value between zero and one that describes the degree of anisotropy of water diffusion in a specified brain area. Higher values indicate a greater degree of anisotropy, while a score of zero indicates isotropic diffusion.
Change in cortico-STN Connectivity
Time frame: Baseline, 30-36 months
Cortico-Subthalamic nucleus connectivity is measured using MRI and reported as a z score (unitless).
Change in paired Associative Stimulation-Motor Evoked Potential (PAS-MEP)
Time frame: Baseline, 30-36 months
Motor evoked potential is measured as the amplitude of change in target muscle electrical activity following transcranial magnetic stimulation (TMS) and reported in units of millivolts (mV).
Change in Mattis Dementia Rating Scale 2 (DRS-2)
Time frame: Baseline, 30-36 months
The DRS-2 consists of 24 items, rated on a scale from 0 to 6. Item scores are combined into five subscales: attention (8 items), initiation/perseveration (11 items), construction (6 items), conceptualization ( 6 items), and memory (5 items). These five subscale scores are summed to calculate a total score ranging from from 0 to 144 points, with lower scores indicating worse performance due to dementia.
Change in Rey Complex Figure and Matrix Reasoning of the Wechsler Adult Intelligence Scale - IV
Time frame: Baseline, 30-36 months
Measure of visuospatial construction, memory and reasoning. Scaled score based on age norms.
Change in Stroop Color Word Test
Time frame: Baseline, 30-36 months
Measure of response inhibition, selective attention and processing. Scaled score based on age norms.
Change in Wisconsin Card Sorting Test
Time frame: Baseline, 30-36 months
Measures cognitive flexibility, abstract reasoning, and set-shifting. Scaled score based on age norms.
Change in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Subtest
Time frame: Baseline, 30-36 months
Measures cognitive flexibility, abstract reasoning, and set-shifting. Scaled score based on age norms.
Change in Brief Visuospatial Memory Test - Revised (BVMT-R)
Time frame: Baseline, 30-36 months
Measure of non-verbal (visuospatial) learning and memory abilities. Scaled score based on age norms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Related trials for Parkinson
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and 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 6 inclusion and 14 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: finished, as of the sponsor's last update on 3 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in volume of Subthalamic Nucleus (time frame: Baseline, 30-36 months). The study lists 10 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 Nov 2026.