Pathways Mediating Impaired Postural Control in Parkinson's Disease (NCT06464029) | Clinical Trial Compass
RecruitingNot Applicable
Pathways Mediating Impaired Postural Control in Parkinson's Disease
United States160 participantsStarted 2024-06-01
Plain-language 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.
Who can participate
Age range
45 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 stud…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
average gate speed
Timeframe: baseline
2
stride length
Timeframe: baseline
3
cadence
Timeframe: baseline
4
turn speed
Timeframe: baseline
5
ankle rigidity
Timeframe: 25mins
6
Root mean square of the excursion of the center of pressure