Pathways Mediating Impaired Postural Control in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Pathways Mediating Impaired Postural Control in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06464029
• Other study ID #: NEUR-2023-31981
• Status: Recruiting
• Start date: June 1, 2024
• Est. completion date: June 10, 2027

Study information

• Verified date: June 2024
• Source: University of Minnesota
• Contact: Joshua De Kam
• Phone: 612-626-8052
• Email: jadekam[@]umn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 10, 2027
• Est. primary completion date: June 10, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average gate speed	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.	baseline
Primary	stride length	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.	baseline
Primary	cadence	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.	baseline
Primary	turn speed	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.	baseline
Primary	ankle rigidity	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.	25mins
Primary	Root mean square of the excursion of the center of pressure	Participants will stand on a set of force platforms that measures the forces and pressures beneath the feet. Primary outcome	5mins
Primary	single pulse TMS	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.	1.5hrs
Primary	Paired-Pulse TMS (Intracortical excitability):	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.	1hr