NCT06464029 · University of Minnesota
Pathways Mediating Impaired Postural Control in Parkinson's Disease
What this study is about
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.
View original scientific description
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.
Primary outcome measures
average gate speed
Time frame: baseline
Participants will walk on an overground pressure walkway (GAITRite, Franklin, NJ) that provides spatiotemporal measures of walking. In addition, they will wear a set of wearable sensors (APDM Inc., Opals) attached to the feet, wrists and trunk (lumbar and sternum) to capture whole-body motion.
stride length
Time frame: baseline
Participants will walk on an overground pressure walkway (GAITRite, Franklin, NJ) that provides spatiotemporal measures of walking. In addition, they will wear a set of wearable sensors (APDM Inc., Opals) attached to the feet, wrists and trunk (lumbar and sternum) to capture whole-body motion.
cadence
Time frame: baseline
Participants will walk on an overground pressure walkway (GAITRite, Franklin, NJ) that provides spatiotemporal measures of walking. In addition, they will wear a set of wearable sensors (APDM Inc., Opals) attached to the feet, wrists and trunk (lumbar and sternum) to capture whole-body motion.
turn speed
Time frame: baseline
Participants will walk on an overground pressure walkway (GAITRite, Franklin, NJ) that provides spatiotemporal measures of walking. In addition, they will wear a set of wearable sensors (APDM Inc., Opals) attached to the feet, wrists and trunk (lumbar and sternum) to capture whole-body motion.
ankle rigidity
Time frame: 25mins
Quantitative measures of rigidity will be obtained using a custom-built robotic manipulandum. The manipulandum moves the ankle through a sinusoidal or triangular range of motion (25 deg of plantar flexion to 5 degrees of dorsiflexion; modified as needed for participant's range of motion) while measuring the resistive torque generated by ankle impedance.
Root mean square of the excursion of the center of pressure
Time frame: 5mins
Participants will stand on a set of force platforms that measures the forces and pressures beneath the feet. Primary outcome
single pulse TMS
Time frame: 1.5hrs
A measure of the excitability of corticospinal pathways. Primary outcome variables: Peak-to-peak amplitude of the motor evoked potential (MEP) responses to TMS in lower limb and trunk muscles.
Paired-Pulse TMS (Intracortical excitability):
Time frame: 1hr
A measure of the excitability of intracortical (motor cortex-motor cortex) inhibitory (short-intracortical inhibition, SICI) and excitatory (short-intracortical inhibition, ICF) networks. Primary outcome variables: Peak-to-peak amplitude of the motor evoked potential (MEP) responses to TMS in lower limb and trunk muscles.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Minneapolis, Minnesota
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations