Clinical trial NCT06464029: Pathways Mediating Impaired Postural Control in Parkinson's Disease
Official title: Pathways Mediating Impaired Postural Control in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with PD will undergo an initial screening for inclusion/exclusion criteria by their clinician based on findings obtained during their routine clinical appointment.

Potential control participants will be screened for inclusion/exclusion criteria during an initial phone call.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: average gate speed
timeFrame: baseline
measure: stride length
timeFrame: baseline
measure: cadence
timeFrame: baseline
measure: turn speed
timeFrame: baseline
measure: ankle rigidity
timeFrame: 25mins
measure: Root mean square of the excursion of the center of pressure
timeFrame: 5mins
measure: single pulse TMS
timeFrame: 1.5hrs
measure: Paired-Pulse TMS (Intracortical excitability):
timeFrame: 1hr
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Colum MacKinnon, MD
role: PRINCIPAL_INVESTIGATOR
References: