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Parkinsons Disease (PD)NCT07024875

Neuroimaging of Parkinson's

An observational study of Parkinsons Disease (PD), run by Washington University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Parkinson's Disease (PD) is a neurodegenerative disorder caused by dysfunction in both subcortical structures and the cortex. The investigators recently discovered a new brain system called the Somato-Cognitive Action Network (SCAN), which could be a primary locus of dysfunction in PD. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Parkinsons Disease (PD)
How many people
120 participants
Where
1 siteUnited States
Study dates
1 Aug 2025to Jan 2031
How long will I take part?
6 Months
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 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 1. Parkinson's Disease (PD) Patients * 70 non-demented individuals with clinically definite PD * Must be 40 years of age or older * Both male \& female * Must not meet dementia criteria 2. Age-matched Healthy Controls * 50 individuals with normal neurological exams and cognition * No first-degree relatives with PD * Also, must be 40 years of age or older

Who may be able to join

  • Must meet specific health and cognitive criteria depending on the group. For PD participants
  • Clinical diagnosis of Parkinson's Disease
  • Must not meet dementia criteria For Healthy Control Participants
  • Normal or benign neurological exam
  • Normal cognition
  • No first-degree relatives with Parkinson's Disease

Who cannot join

  • Neurological Disorders (other than PD)
  • Any other neurological condition
  • Significant Head Injury
  • Head injury with loss of consciousness >5 minutes
  • Or any neurological sequelae
  • Psychiatric Disorders
Show all 19Show fewer
  • Schizophrenia
  • Bipolar Disorder
  • Epilepsy
  • Serious Medical Conditions
  • End-stage organ failure
  • Ongoing cancer treatment
  • Cognitive Impairment
  • Diagnosis of dementia
  • MMSE score <24 or MoCA score <21
  • MRI contraindications
  • Metal implants
  • claustrophobia
  • Weight over 300 lbs (due to weight restrictions of the MRI scanner)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Danny Bower contact

314-273-4429

bower@wustl.edu

United States1 site, 1 recruiting
  • East Imaging Building

    St Louis, Missouri, 63110

    Recruiting

Other trials in United States

About this study

Official title: Precision Neuroimaging of Parkinson's Disease

Parkinson's Disease (PD) is a neurodegenerative disorder caused by dysfunction in both subcortical structures and the cortex. The investigators recently discovered a new brain system called the Somato-Cognitive Action Network (SCAN), which could be a primary locus of dysfunction in PD. Here, the investigators will use magnetic resonance imaging techniques in PD patients to test whether SCAN is critical for PD. The investigators will determine whether SCAN is connected to PD-relevant subcortical structures, and whether PD patients exhibit altered subcortical-to-SCAN connectivity. If successful, this work will identify SCAN as a specific circuit altered in PD patients that can serve as a new target for future neuromodulatory PD therapies.

Read the detailed description

Parkinson's Disease (PD) is a neurodegenerative disease that causes symptoms such as tremor, bradykinesia, and freezing of gait, as well as sleep disturbance, autonomic dysfunction, and abulia. PD patients particularly struggle to initiate and maintain actions, which causes gait freezing, leading to falls. PD results from dysfunction in motor circuitry, including connections between subcortical structures such as substantia nigra and striatum, as well as primary motor cortex, which drives voluntary movement.

Recently, our group rewrote the textbook diagrams of motor circuitry. The investigators described a previously unrecognized Somato-Cognitive Action Network (SCAN) which is interspersed between effector-specific regions of primary motor cortex (foot, hand, mouth). The SCAN is engaged by coordinated rather than isolated actions, and it is strongly preferentially connected to other cortical regions important for action planning and control, autonomic function, and arousal.

Many SCAN functions (drive to act, gait, autonomic control, arousal, motor coordination) are affected in PD. Further, clinical targets for neuromodulation in PD are connected to SCAN. Thus, SCAN dysfunction might be an important aspect of PD pathophysiology and resulting symptoms. Critically, recent technical advances in noninvasive functional neuroimaging allow us for the first time to reliably evaluate the connectivity of motor systems, including SCAN, into the deep subcortical structures most relevant for PD.

Using these patient-oriented techniques, the investigators will first test whether PD-relevant subcortical structures-including clinical targets for PD-are connected more strongly to the SCAN circuit than to effector-specific M1 foot, hand, and mouth regions. The investigators will then test whether these subcortical-to-SCAN circuits are altered in PD patients to a greater degree than effector-specific circuits.

This work will advance a new conceptualization of PD as a disorder of SCAN rather than of traditional effector-specific M1, which will revolutionize how the investigators think of the disorder. Localizing PD disruption to specific portions of M1 could aid with evaluation of patients using these advanced, noninvasive fMRI techniques, and can provide precision targets of interest for other imaging modalities. Noninvasive mapping of cortico-subcortical connectivity will enable optimal target definition for neuromodulatory treatment of PD. Reconceptualizing PD as a disorder of SCAN, a system for integrated action, rather than of M1 circuits for isolated movement, may spur development of alternate symptom evaluation tools oriented around this framework. Finally, localizing M1 sites of disruption in PD opens the possibility of treating PD using cortical stimulation, a less-invasive alternative to deep brain stimulation.

Keywords
Neurology, Radiology, FMRI, Precision Neuroimaging, Resting-State Functional Connectivity, Subcortical Structures, Functional MRI, Brain Imaging Data Structure, Gait Analysis, Motor Cortex Connectivity, Non-Demented Parkinson's, Openneuro Repository, Observational Cohort Study, Action Initiation, Freezing of Gait, Parkinson's Disease, Somato-Cognitive Action Network (SCAN), Precision Functional Mapping, Parkinson Disease (PD)
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 groups in NCT07024875
Study groupRoleWhat they receive
Parkinson's Participants* 70 non-demented individuals with clinically definite PD * Must be 40 years of age or older * Both male \& female
Healthy Control* 50 individuals with normal neurological exams and cognition * No first-degree relatives with PD * Also, must be 40 years of age or older

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cortico-subcortical connectivity to SCAN vs effectors

    We will collect resting-state functional magnetic resonance imaging (fMRI) scans from the brains of all participants. From the fMRI scans, we will compute the functional connectivity between each of the subcortical brain structures relevant for Parkinson's disease (including substantia nigra, subthalamic nucleus, globus pallidus internus, and ventral intermediate nucleus of the thalamus) and each subdivision of primary motor cortex (Somato-Cognitive Action network and effector-specific regions controlling the hand, foot, and face). Functional connectivity will be computed as pairwise temporal correlations of the activity timecourses in each location.

    We hypothesize that subcortical structures will exhibit differential functional connectivity to the Somato-Cognitive Action network than to the effector-specific regions of primary motor cortex.

    Measured: 6 months per participant; 3-4 sessions for controls, 6-8 sessions for PD patients

Secondary outcomes (1)
  1. Cortico-subcortical connectivity to SCAN in Parkinson's and controls

    We will collect resting-state functional magnetic resonance imaging (fMRI) scans from the brains of all participants. From the fMRI scans, we will compute the functional connectivity between each of the subcortical brain structures relevant for Parkinson's disease (including substantia nigra, subthalamic nucleus, globus pallidus internus, and ventral intermediate nucleus of the thalamus) and each subdivision of primary motor cortex (Somato-Cognitive Action network and effector-specific regions controlling the hand, foot, and face). Functional connectivity will be computed as pairwise temporal correlations of the activity timecourses in each location.

    We hypothesize that people with Parkinson's Disease will exhibit differential functional connectivity than controls between subcortical structures and the Somato-Cognitive Action network.

    Measured: 6 months per participant; 3-4 sessions for controls, 6-8 sessions for PD patients

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2025
  2. Study start1 Aug 2025
  3. Primary completionJan 2031 (estimated)
  4. Study completionJan 2031 (estimated)

Resources

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
120 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07024875
Sponsor's protocol ID
202410006
Other IDs
R01NS140256
Status last verified
Apr 2026
First submitted
9 Jun 2025
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD, including de-identified neuroimaging data, summary measures from clinical and motor assessments, summary measures from behavioral tasks, summary measures from psychiatric questionnaires, \& anonymized demographic data.

Publications

  • Cui W, Wang Y, Ren J, Hubbard CS, Fu X, Fang S, Wang D, Zhang H, Li Y, Li L, Jiang T, Liu H. Personalized fMRI Delineates Functional Regions Preserved within Brain Tumors. Ann Neurol. 2022 Mar;91(3):353-366. doi: 10.1002/ana.26303. Epub 2022 Jan 31.

    PubMed 35023218
  • Ren J, Chi Q, Hubbard CS, Cui W, Wang D, Li L, Zhang H, Liu H. Personalized functional imaging identifies brain stimulation target for a patient with trauma-induced functional disruption. Brain Stimul. 2022 Jan-Feb;15(1):53-56. doi: 10.1016/j.brs.2021.11.005. Epub 2021 Nov 5. No abstract available.

    PubMed 34749006
  • Guo Y, Ren J, Cui W, Dahmani L, Wang D, Fu X, Li M, Li S, Zhang Y, Lin X, Zhen Z, Xu Y, Xie D, Guan H, Yi F, Wang J, Shi Q, Liu H. Personalized brain MRI revealed distinct functional and anatomical disruptions in Creutzfeldt-Jakob disease and Alzheimer's disease. CNS Neurosci Ther. 2024 Feb;30(2):e14404. doi: 10.1111/cns.14404. Epub 2023 Aug 14.

    PubMed 37577861
  • Dahmani L, Bai Y, Li M, Ren J, Shen L, Ma J, Li H, Wei W, Li P, Wang D, Du L, Cui W, Liu H, Wang M. Focused ultrasound thalamotomy for tremor treatment impacts the cerebello-thalamo-cortical network. NPJ Parkinsons Dis. 2023 Jun 15;9(1):90. doi: 10.1038/s41531-023-00543-8.

    PubMed 37322044
  • Ji GJ, Liu T, Li Y, Liu P, Sun J, Chen X, Tian Y, Chen X, Dahmani L, Liu H, Wang K, Hu P. Structural correlates underlying accelerated magnetic stimulation in Parkinson's disease. Hum Brain Mapp. 2021 Apr 15;42(6):1670-1681. doi: 10.1002/hbm.25319. Epub 2020 Dec 14.

    PubMed 33314545
  • Hill KK, Campbell MC, McNeely ME, Karimi M, Ushe M, Tabbal SD, Hershey T, Flores HP, Hartlein JM, Lugar HM, Revilla FJ, Videen TO, Earhart GM, Perlmutter JS. Cerebral blood flow responses to dorsal and ventral STN DBS correlate with gait and balance responses in Parkinson's disease. Exp Neurol. 2013 Mar;241:105-12. doi: 10.1016/j.expneurol.2012.12.003. Epub 2012 Dec 19.

    PubMed 23262122
  • Myers PS, McNeely ME, Koller JM, Earhart GM, Campbell MC. Cerebellar Volume and Executive Function in Parkinson Disease with and without Freezing of Gait. J Parkinsons Dis. 2017;7(1):149-157. doi: 10.3233/JPD-161029.

    PubMed 28106569
  • Horin AP, Myers PS, Pickett KA, Earhart GM, Campbell MC. Resting-state functional connectivity associated with gait characteristics in people with Parkinson's disease. Behav Brain Res. 2021 Aug 6;411:113398. doi: 10.1016/j.bbr.2021.113398. Epub 2021 Jun 2.

    PubMed 34087255
  • Maiti B, Rawson KS, Tanenbaum AB, Koller JM, Snyder AZ, Campbell MC, Earhart GM, Perlmutter JS. Functional Connectivity of Vermis Correlates with Future Gait Impairments in Parkinson's Disease. Mov Disord. 2021 Nov;36(11):2559-2568. doi: 10.1002/mds.28684. Epub 2021 Jun 10.

    PubMed 34109682
  • Nemanich ST, McNeely ME, Earhart GM, Norris SA, Black KJ. A Case of Apparent Upper-Body Freezing in Parkinsonism while Using a Wheelchair. Front Neurol. 2017 May 15;8:205. doi: 10.3389/fneur.2017.00205. eCollection 2017.

    PubMed 28555128
  • Horin AP, Harrison EC, Rawson KS, Earhart GM. People with Parkinson disease with and without freezing of gait respond similarly to external and self-generated cues. Gait Posture. 2020 Oct;82:161-166. doi: 10.1016/j.gaitpost.2020.09.005. Epub 2020 Sep 6.

    PubMed 32932076
  • Baudendistel ST, Haussler AM, Rawson KS, Earhart GM. Minimal clinically important differences of spatiotemporal gait variables in Parkinson disease. Gait Posture. 2024 Feb;108:257-263. doi: 10.1016/j.gaitpost.2023.11.016. Epub 2023 Nov 25.

    PubMed 38150946
  • Girnis JL, Cavanaugh JT, Baker TC, Duncan RP, Fulford D, LaValley MP, Lawrence M, Nordahl T, Porciuncula F, Rawson KS, Saint-Hilaire M, Thomas CA, Zajac JA, Earhart GM, Ellis TD. Natural Walking Intensity in Persons With Parkinson Disease. J Neurol Phys Ther. 2023 Jul 1;47(3):146-154. doi: 10.1097/NPT.0000000000000440. Epub 2023 Apr 4.

    PubMed 37016469
  • Zajac JA, Cavanaugh JT, Baker T, Duncan RP, Fulford D, Girnis J, LaValley M, Nordahl T, Porciuncula F, Rawson KS, Saint-Hilaire M, Thomas CA, Earhart GM, Ellis TD. Does clinically measured walking capacity contribute to real-world walking performance in Parkinson's disease? Parkinsonism Relat Disord. 2022 Dec;105:123-127. doi: 10.1016/j.parkreldis.2022.11.016. Epub 2022 Nov 15.

    PubMed 36423521
  • Rawson KS, McNeely ME, Duncan RP, Pickett KA, Perlmutter JS, Earhart GM. Exercise and Parkinson Disease: Comparing Tango, Treadmill, and Stretching. J Neurol Phys Ther. 2019 Jan;43(1):26-32. doi: 10.1097/NPT.0000000000000245.

    PubMed 30531383

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinsons Disease (PD), run by Washington University School of Medicine 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 19 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 13 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 Danny Bower (314-273-4429, bower@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cortico-subcortical connectivity to SCAN vs effectors (time frame: 6 months per participant; 3-4 sessions for controls, 6-8 sessions for PD patients). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07024875, which also lists 154 linked publications.

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 13 Apr 2026.

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