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Pathways Mediating Impaired Postural Control in Parkinson's Disease

Pathways Mediating Impaired Postural Control in Parkinson's Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06464029
Enrollment
160
Registered
2024-06-18
Start date
2024-06-01
Completion date
2027-06-10
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

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

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.

Interventions

None listed

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
average gate speedbaselineParticipants 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 lengthbaselineParticipants 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.
cadencebaselineParticipants 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 speedbaselineParticipants 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 rigidity25minsQuantitative 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 pressure5minsParticipants will stand on a set of force platforms that measures the forces and pressures beneath the feet. Primary outcome
single pulse TMS1.5hrsA 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):1hrA 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.

Countries

United States

Contacts

CONTACTJoshua De Kam
jadekam@umn.edu612-626-8052
PRINCIPAL_INVESTIGATORColum MacKinnon, MD

University of Minnesota

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026