RecruitingNot ApplicableNCT05818189

Cortical Correlates of Gait in Parkinson's Disease: Impact of Medication and Cueing

Sponsor

Oregon Health and Science University

Enrollment

60 participants

Start Date

Jan 15, 2025

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

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

Min Age: 45 YearsMax Age: 85 Years

Inclusion Criteria4

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 Criteria4

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.

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Interventions

DEVICEPersonalized tactile cueing

We will use as an external cue, a system of tactile cueing with the purpose of enhancing proprioceptive inputs, in the form of real-time(synchronized to the gait heel strike), closed-loop tactile feedback signaling left and right stance times while walking. Also, the participants use the same system cueing in closed-loop feedback during daily life for one week.

DEVICEFixed tactile cueing

We will use as an external cue, a system of tactile cueing with the purpose of enhancing proprioceptive inputs, in the form of real-time, open-loop(fixed rhythm) tactile feedback signaling left and right stance times while walking. Also, the participants use the same system cueing in open-loop feedback during daily life for one week.