Pathways Mediating Impaired Postural Control in Parkinson's Disease

Recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT06464029
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-01
• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-10
• Last Update Submitted: 2024-06-10
• Study First Posted: 2024-06-18
• Last Update Posted: 2024-06-18
• Primary Completion: 2027-06-10
• Study Completion: 2027-06-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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)

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
average gate speed	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	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	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	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	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	5mins	Participants will stand on a set of force platforms that measures the forces and pressures beneath the feet. Primary outcome
single pulse TMS	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):	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States