Actively Recruiting

Phase Not Applicable
Age: 45Years - 85Years
All Genders
NCT05818189

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

Led by Oregon Health and Science University · Updated on 2025-12-17

60

Participants Needed

1

Research Sites

158 weeks

Total Duration

On this page

Sponsors

O

Oregon Health and Science University

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of idiopathic Parkinson's Disease by a movement disorders neurologist using the United Kingdom Brain Bank criteria with bradykinesia plus rest tremor, rigidity, or balance problems not caused by visual, vestibular, cerebellar, or proprioceptive conditions
  • No musculoskeletal or peripheral or central nervous system disorders (other than PD) significantly affecting balance and gait
  • Ability to follow directions and provide informed consent
  • Hoehn & Yahr Levels II-III
Not Eligible

You will not qualify if you...

  • Severe dyskinesia affecting quality of brain activity measurements
  • Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, or acute illness affecting gait or turning
  • Peripheral neuropathy with proprioceptive deficits
  • Montreal Cognitive Assessment (MoCA) score below 21 or dementia preventing consent or participation
  • Inability to stand or walk for 2 minutes without an assistive device
  • Parkinson plus syndromes or implanted deep brain stimulation electrodes
  • Possible vascular parkinsonism
  • Current use of dopamine-blocking agents or cholinesterase inhibitors affecting prefrontal cortex activity while walking

AI-Screening

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Trial Site Locations

Total: 1 location

1

Oregon Health and Science University

Portland, Oregon, United States, 97239

Actively Recruiting

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Research Team

F

Francesa Alcalá, B.S.

CONTACT

G

Graham Harker, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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