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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT05818189
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Personalized tactile cueing — DEVICE
    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.
  • Fixed tactile cueing — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 15, 2025
Status verified
Dec 2025
Primary completion
Oct 1, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Personalized cueing
    Personalized, step-synchronized tactile cueing, enhancing proprioceptive inputs, in the form of real-time, closed-loop tactile feedback signaling left and right stance times while walking
  • Active Comparator: Fixed cueing
    Tactile cueing at fixed intervals, enhancing proprioceptive inputs, in the form of open-loop tactile feedback (fixed rhythm) signaling left and right stance times while walking

Primary Outcome Measure

Prefrontal cortex activity [ Time Frame: day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health and Science UniversityPortlandOregon97239
Francesca Alcalá, B.S.
[email protected]
503-913-3691
Graham Harker, MPH
[email protected]
503-418-2601
Martina Mancini, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Portland, OR

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Oregon Health and Science University· Portland, OR

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