Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT06464029

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Study Details

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 ID

NCT06464029

Start date

Jun 1, 2024

Status verified date

Jun, 2026

Completion date

Jun 10, 2027

Anticipated

Primary completion date

Jun 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • average gate speed [ Time Frame: baseline ]
  • stride length [ Time Frame: baseline ]
  • cadence [ Time Frame: baseline ]
  • turn speed [ Time Frame: baseline ]
  • ankle rigidity [ Time Frame: 25mins ]
  • Root mean square of the excursion of the center of pressure [ Time Frame: 5mins ]
  • single pulse TMS [ Time Frame: 1.5hrs ]
  • Paired-Pulse TMS (Intracortical excitability): [ Time Frame: 1hr ]

Central Contacts and Locations

Central contacts

Joshua De Kam

612-626-8052jadekam@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

More Information

Sponsor

University of Minnesota

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • gait
  • posture
  • transcranial magnetic stimulation
  • Parkinson's disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-07-02.