Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05818189 |
| Other study ID # |
R01HD110389 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2024 |
| Est. completion date |
January 31, 2028 |
Study information
| Verified date |
June 2024 |
| Source |
Oregon Health and Science University |
| Contact |
Martina Mancini, PhD |
| Phone |
5034182600 |
| Email |
mancinim[@]ohsu.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 Parkinson's Disease, 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 Parkinson's
Disease 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 Parkinson's Disease. 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 Parkinson's Disease.
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. We will explore feasibility and efficacy of cueing in
daily life comparing data of gait and turning from a week of continuous monitoring without
and with using the tactile cueing. In addition, we will test whether any retention on gait
and turning is present by adding a third week of continuous monitoring.
