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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06464029
Other study ID # NEUR-2023-31981
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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