Pathways Mediating Impaired Postural Control in Parkinson's Disease

NCT ID: NCT06464029

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2027-06-10

Brief Summary

The purpose of this project is to use transcranial magnetic stimulation (TMS) to explore the state of excitability of corticocortical and corticofugal (cortex to spinal cord, cortex to brainstem to spinal cord) pathways that project to muscles that control the legs and trunk in people with Parkinson's disease. The outcome variables will be further analyzed to understand their relationship to quantitative measures of postural instability and gait dysfunction. As such, the project can be classified as basic physiologic research. The protocol is not designed to determine if measures of corticocortical or corticofugal excitability can be used as a biomarker to predict disease progression.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Control

40 healthy older adults and 40 young adults. Potential volunteers for the study will be recruited from a list of volunteers at the University of Minnesota or study information pamphlets distributed people who express an interest in participating (e.g. at research events, support group meetings, or to colleagues of participants tested). Interested individuals will self-identify and contact our research staff for further information.

No interventions assigned to this group

Experimental

40 people with Parkinson's disease. Potential volunteers will be recruited from the Movement Disorders Clinic at the University of Minnesota Medical Center. Patients that are referred to this center for standard-of-care evaluations will be seen by a movement disorders neurologist. Patients will be evaluated as per standard of care, regardless of whether they are interested in participating in research protocols.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Participants with Parkinson's disease

• Diagnosis of idiopathic PD or dystonia as determined by a movement disorders neurologist in accordance with the UK Society Brain Bank diagnostic criteria.
• Age 45-80 years.
• Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters.

Healthy Older Adults (Control participants)

• Age 45-80 years (this group will be age and sex-matched to the PD group)
• Able to ambulate independently without the use of an assistive device (cane or walker)

Healthy Young Adults

• Age 21-44 years (this group will be age and sex-matched to the PD group)
• Able to ambulate independently without the use of an assistive device (cane or walker)

Exclusion Criteria

• Subjects who describe a history of a frequent vasovagal syncope (fainting) in response to blood, emotional stress, or sensory triggers.
• Subjects who are on anti-coagulant medications.
• Any musculoskeletal disorder that affects the ability to stand.
• History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury.
• Intracranial metallic or magnetic devices.
• Pacemaker or any implanted device.
• History of surgery on blood vessels, brain or heart.
• Unexplained, recurring headaches or concussion within the last six months.
• Moderate to severe hearing impairment.
• Subjects who are pregnant.
• Dementia diagnosis
• Other significant neurological disorders that may affect participation or performance in the study
• Implanted deep brain stimulator or other neurosurgeries to treat PD.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colum MacKinnon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joshua De Kam

Role: CONTACT

jadekam@umn.edu

612-626-8052

Other Identifiers

NEUR-2023-31981

Identifier Type: -

Identifier Source: org_study_id