RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-15
Study Completion:2028-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05818189

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Without musculoskeletal or peripheral or central nervous system disorders (other than PD) that could significantly affect their balance and gait
  3. * All subjects will be capable of following directions for the protocols and to give informed consent.
  4. * Hoehn \& Yahr Levels II-III.
  1. * Severe dyskinesia that may affect quality of fNIRS.
  2. * 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.
  3. * Montreal cognitive assessment (MoCA) score \< 21 or dementia that precludes consent to participate or ability to follow testing procedures
  4. * Inability to stand or walk for 2 minutes without an assistive device.
  5. * Idiopathic Parkinson's Disease

Contacts and Locations

Study Contact

Francesa Alcalá, B.S.
CONTACT
503-913-3691
alcalaf@ohsu.edu
Graham Harker, MPH
CONTACT
503-418-2601
harkerh@ohsu.edu

Principal Investigator

Martina Mancini, PhD
PRINCIPAL_INVESTIGATOR
Oregon Health and Science University

Study Locations (Sites)

Oregon Health and Science University
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

  • Martina Mancini, PhD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-15
Study Completion Date2028-01-31

Study Record Updates

Study Start Date2025-01-15
Study Completion Date2028-01-31

Terms related to this study

Keywords Provided by Researchers

  • Tactile cueing
  • Gait
  • Turning
  • Cortical activity

Additional Relevant MeSH Terms

  • Parkinson Disease