NCT05818189 Cortical Correlates of Gait in Parkinson's Disease: Impact of Medication and Cueing
| NCT ID | NCT05818189 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oregon Health and Science University |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-01-15 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to determine the effects of a novel, personalized, tactile cueing system on gait automaticity. The researchers hypothesized that step-synchronized tactile cueing will reduce prefrontal cortex activity (improve automaticity) and improve gait variability (as well as gait speed). The researchers predict that improved automaticity with improved gait variability will be associated with increased activation of other than prefrontal cortical areas while walking (i.e., sensory-motor). To determine the effects of cueing, 60 participants with PD from will be randomized into one, of two, cueing interventions: 1) personalized, step-synchronized tactile cueing and 2) tactile cueing at fixed intervals as an active control group. In addition, the researchers will explore the feasibility and potential benefits of independent use of tactile cueing during a week in daily life for a future clinical trial. This project will characterize the cortical correlates of gait automaticity, the changes in gait automaticity with cueing in people with Parkinson's Disease, and how these changes translate to improvement in gait and turning. The long-term goal is to unravel the mechanisms of impaired gait automaticity in Parkinson's Disease.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of idiopathic Parkinson's Disease from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia with 1 or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions * Without musculoskeletal or peripheral or central nervous system disorders (other than PD) that could significantly affect their balance and gait * All subjects will be capable of following directions for the protocols and to give informed consent. * Hoehn \& Yahr Levels II-III. Exclusion Criteria: * Severe dyskinesia that may affect quality of fNIRS. * Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than Parkinson's Disease, significantly affecting gait and turning i.e., peripheral neuropathy with proprioceptive deficits (detected as lack of toe proprioception assessed during the neurological exam at Day 1), musculoskeletal disorders, vestibular problem, head injury, stroke. * Montreal cognitive assessment (MoCA) score \< 21 or dementia that precludes consent to participate or ability to follow testing procedures * Inability to stand or walk for 2 minutes without an assistive device. * Idiopathic Parkinson's Disease exclusion criteria: Parkinson plus syndromes such as progressive supranuclear palsy, multiple system atrophy, or corticobasal syndrome or implanted electrodes for deep brain stimulation (DBS), possible vascular parkinsonism, current use of dopamine-blocking agents or cholinesterase inhibitor (as may affect Prefrontal cortical activity while walking).
Contact & Investigator
Martina Mancini, PhD
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT05818189 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 85 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05818189 currently recruiting?
Yes, NCT05818189 is actively recruiting participants. Contact the research team at alcalaf@ohsu.edu for enrollment information.
Where is the NCT05818189 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT05818189 clinical trial?
NCT05818189 is sponsored by Oregon Health and Science University. The principal investigator is Martina Mancini, PhD at Oregon Health and Science University. The trial plans to enroll 60 participants.
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