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

Sponsor

Oregon Health and Science University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05818189

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Gait Disorders, Neurologic Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Movement Disorders	Device: Personalized tactile cueing Device: Fixed tactile cueing	N/A

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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

The kind of cueing will be blind for the research participant and the researchers.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Oct 1, 2027

Anticipated Study Completion Date :

Jan 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
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	Device: Personalized tactile cueing 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. Other Names: personalized
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	Device: Fixed tactile cueing 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. Other Names: fixed

Arm

Intervention/Treatment

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

Device: Personalized tactile cueing

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.

Other Names:

personalized

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

Device: Fixed tactile cueing

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.

Other Names:

fixed

Outcome Measures

Primary Outcome Measures

Prefrontal cortex activity [1 day]
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 [1 day]
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 [1 week]
Using 6 Opals of the system mobility lab, we will compute the stride time variability
Gait speed [1 week]
Using 6 Opals of the system mobility lab, we will compute the gait speed
Turning duration [1 week]
Using 6 Opals of the system mobility lab, we will compute the turning duration
Turning jerkiness [1 week]
Using 6 Opals of the system mobility lab, we will compute the turning jerkiness as a metrics of smoothness of motion.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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).