Cortical Correlates of Gait in Parkinson's Disease: Impact of Medication and Cueing
cueing
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Jan 2025
Typical duration for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedStudy Start
First participant enrolled
January 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
December 17, 2025
December 1, 2025
2.7 years
April 5, 2023
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Prefrontal cortex activity
Oxygenated hemoglobin over the prefrontal cortex measures by fNIRS
day 1
Parietal cortex activity
Oxygenated hemoglobin over the parietal cortex measures by fNIRS
day 1
Stride time variability
Variability of stride time during 2 minute walking
day 1
Local Dynamic Stability
Stability during gait is assessed by phase dependent local dynamic stability (LDS) measures of the trunk acceleration while walking
day 1
Turn duration
Average duration of 360 turning while performing a 1 minute turning in place task
day 1
Turn jerk
Average turning smoothness while performing a 1 minute turning in place task
day 1
Secondary Outcomes (13)
Supplementary motor area cortical activity
day 1
Occipital cortical activity
day 1
Gait speed
day 1
Gait speed variability
day 1
Stride time
day 1
- +8 more secondary outcomes
Study Arms (2)
Personalized cueing
EXPERIMENTALPersonalized, 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
Fixed cueing
ACTIVE COMPARATORTactile 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health and Science University
Portland, Oregon, 97239, United States
Related Publications (1)
Burgos PI, Liu W, Silva-Batista C, Baker-Alcala F, Carlson-Kuhta P, King LA, Horak FB, Chung KA, Lapidus JA, Mancini M. Personalized versus fixed tactile cueing in Parkinson's disease: Protocol for a randomized controlled trial on gait automaticity. PLoS One. 2025 Nov 21;20(11):e0336859. doi: 10.1371/journal.pone.0336859. eCollection 2025.
PMID: 41270079DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martina Mancini, PhD
Oregon Health and Science University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The subjects will not know which intervention is favored for improving gait automaticity and the researchers analyzing the data will not know which intervention group subjects were randomly assigned.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 5, 2023
First Posted
April 18, 2023
Study Start
January 15, 2025
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
January 31, 2028
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data would be available 6 months after the end of data collection. Data will be stored in our laboratory data repository and so will be available indefinitely.
- Access Criteria
- Data will not be stored on a public website, however researchers may contact us for access to the data. We will send data electronically via a secure server.
Upon reasonable request, we can share de-identified data related to study outcomes measures.