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Cortical Correlates of Gait Automaticity and Daily Life Mobility in Parkinson's Disease (cueing)

Primary Purpose

Parkinson Disease, Gait Disorders, Neurologic, Parkinsonian Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Personalized tactile cueing
Fixed tactile cueing
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Fixed vibrotactile cueing, Personalized vibrotactile cueing, Balance

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of idiopathic PD 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 Criteria: Severe dyskinesia that may affect quality of fNIRS. Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD, significantly affecting gait and turning i.e., peripheral neuropathy with proprioceptive deficits (detected as lack of toe proprioception assed during the neurological exam at Day 1), musculoskeletal disorders, vestibular problem, head injury, stroke. Montreal cognitive assessment (MoCA) <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. Idiopathic PD exclusion criteria: Parkinson plus syndromes such as progressive supranuclear palsy, multiple system atrophy, or corticobasal syndrome or implanted electrodes for deep brain stimulation (DBS), possible vascular parkinsonism, current use of dopamine-blocking agents or cholinesterase inhibitor (as may affect PFC activity while walking).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Personalized cueing

    Fixed cueing

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Prefrontal cortex activity
    The automaticity of the gait will be measured by the mean of the Prefrontal Cortex activity recorded by an fNIRS system (Artinis Octamon)

    Secondary Outcome Measures

    Sensory, motor and occipital cortex activity
    By mean a full cap fnirs device we will estimate the activities of the cortex in the motor, sensorial and parietal regions during 2 minutes of recording during gait, and during turning.
    Gait Variability
    Using 6 Opals of the system mobility lab, we will compute the stride time variability
    Gait speed
    Using 6 Opals of the system mobility lab, we will compute the gait speed
    Turning duration
    Using 6 Opals of the system mobility lab, we will compute the turning duration
    Turning jerkiness
    Using 6 Opals of the system mobility lab, we will compute the turning jerkiness as a metrics of smoothness of motion.

    Full Information

    First Posted
    April 5, 2023
    Last Updated
    April 17, 2023
    Sponsor
    Oregon Health and Science University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05818189
    Brief Title
    Cortical Correlates of Gait Automaticity and Daily Life Mobility in Parkinson's Disease
    Acronym
    cueing
    Official Title
    Cortical Correlates of Gait Automaticity and Daily Life Mobility in Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    October 1, 2027 (Anticipated)
    Study Completion Date
    January 31, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Oregon Health and Science University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 PD, 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 PD.
    Detailed Description
    Cortical correlates of gait automaticity in Parkinson's disease: impact of cueing A well-recognized hallmark of healthy walking is automaticity, defined as the ability of the nervous system to successfully coordinate movement with minimal use of attention-demanding, executive resources. It has been proposed that many walking abnormalities in people with Parkinson's disease (PD) are characterized by a shift in locomotor control from healthy automaticity to compensatory, executive control. This shift to less automaticity is potentially detrimental to walking performance as executive control strategies are not optimized for locomotor control, place excessive demands on a limited cognitive reserve, and continuously require attention. It has been hypothesized that as gait becomes more variable, as in people with PD, control of gait is less automatic, i.e., requires more prefrontal cortex involvement. However, as gait variability is not a direct measure of automaticity, it is controversial whether it truly reflects impaired gait automaticity or impaired gait stability (i.e., dynamic balance). The recent development of wireless, functional, near-infrared spectroscopy (fNIRS) of the brain provides more direct, physiological measures of automaticity, such as reduced prefrontal cortex activity. However, the contribution of other cortical areas to the concept of gait automaticity is largely unknown. Here, for the first time, the researchers will use a full cap fNIRS system to monitor cortical activity in multiple brain areas and wearable, inertial sensors to determine how cognitive abilities, levodopa, and cueing influence gait automaticity. The effects of cognitive dysfunction and interventions on gait in people with PD are complex. Impaired executive function has been associated with impaired gait and balance in PD, but it is not known if this relationship is due to the inability to compensate for poor basal ganglia control of gait automaticity with increased prefrontal cortex activity while walking. Sensory cueing may increase gait speed and reduce prefrontal activity but unlike levodopa, it may result in reduced gait variability due to enhanced automaticity. The researchers recently developed a novel type of personalized (triggered by the subject's own walking pattern), step-synchronized tactile stimulation on the wrists to improve the quality of gait and turning in people with PD. The researchers will now compare the effects of cognitive dysfunction, dopaminergic medication, and tactile cueing on the quality of gait and turning and investigate whether improvements reflect changes in prefrontal activity. This project will characterize the cortical correlates of gait automaticity, the changes in gait automaticity with cueing in people with PD, 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 PD. 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). We 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. A secondary analysis will explore whether the effect of cueing on gait automaticity is influenced by cognitive dysfunction. In addition, we will explore the feasibility and potential benefits of independent use of tactile cueing during a week in daily life for a future clinical trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease, Gait Disorders, Neurologic, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Movement Disorders
    Keywords
    Fixed vibrotactile cueing, Personalized vibrotactile cueing, Balance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    60 participants with PD from Aim I, 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. We will analyze the immediate effects of the cueing intervention on gait automaticity. In addition, we will explore the feasibility and potential benefits of independent use of tactile cueing during a week in daily life for a future clinical trial.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    The kind of cueing will be blind for the research participant and the researchers.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Personalized cueing
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Fixed cueing
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    Personalized tactile cueing
    Other Intervention Name(s)
    personalized
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Fixed tactile cueing
    Other Intervention Name(s)
    fixed
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Prefrontal cortex activity
    Description
    The automaticity of the gait will be measured by the mean of the Prefrontal Cortex activity recorded by an fNIRS system (Artinis Octamon)
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Sensory, motor and occipital cortex activity
    Description
    By mean a full cap fnirs device we will estimate the activities of the cortex in the motor, sensorial and parietal regions during 2 minutes of recording during gait, and during turning.
    Time Frame
    1 day
    Title
    Gait Variability
    Description
    Using 6 Opals of the system mobility lab, we will compute the stride time variability
    Time Frame
    1 week
    Title
    Gait speed
    Description
    Using 6 Opals of the system mobility lab, we will compute the gait speed
    Time Frame
    1 week
    Title
    Turning duration
    Description
    Using 6 Opals of the system mobility lab, we will compute the turning duration
    Time Frame
    1 week
    Title
    Turning jerkiness
    Description
    Using 6 Opals of the system mobility lab, we will compute the turning jerkiness as a metrics of smoothness of motion.
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of idiopathic PD 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 Criteria: Severe dyskinesia that may affect quality of fNIRS. Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD, significantly affecting gait and turning i.e., peripheral neuropathy with proprioceptive deficits (detected as lack of toe proprioception assed during the neurological exam at Day 1), musculoskeletal disorders, vestibular problem, head injury, stroke. Montreal cognitive assessment (MoCA) <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. Idiopathic PD exclusion criteria: Parkinson plus syndromes such as progressive supranuclear palsy, multiple system atrophy, or corticobasal syndrome or implanted electrodes for deep brain stimulation (DBS), possible vascular parkinsonism, current use of dopamine-blocking agents or cholinesterase inhibitor (as may affect PFC activity while walking).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Martina Mancini, PhD
    Phone
    5034182600
    Email
    mancinim@ohsu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pablo Burgos, PhD
    Phone
    9713314101
    Email
    burgosp@ohsu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patty Carlson-Kuhta, PhD
    Organizational Affiliation
    Oregon Health and Science University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Upon reasonable request, we can share de-identified data related to study outcomes measures.
    IPD Sharing 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.
    IPD Sharing 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.

    Learn more about this trial

    Cortical Correlates of Gait Automaticity and Daily Life Mobility in Parkinson's Disease

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