Recruiting

Medication with Cueing

Sponsor:

Oregon Health and Science University

Code:

NCT05818189

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Personalized tactile cueing

Fixed tactile cueing

Study Details

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.

Conditions

Parkinson Disease

Study ID

NCT05818189

Start date

Jan 15, 2025

Status verified date

Dec, 2025

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

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 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.
  • Idiopathic Parkinson's Disease 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 Prefrontal cortical activity while walking).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

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.

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.

Primary outcome measure

  • Prefrontal cortex activity [ Time Frame: day 1 ]
  • Parietal cortex activity [ Time Frame: day 1 ]
  • Stride time variability [ Time Frame: day 1 ]
  • Local Dynamic Stability [ Time Frame: day 1 ]
  • Turn duration [ Time Frame: day 1 ]
  • Turn jerk [ Time Frame: day 1 ]

Central Contacts and Locations

Central contacts

Francesa Alcalá, B.S.

503-913-3691alcalaf@ohsu.edu

Graham Harker, MPH

503-418-2601harkerh@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Francesca Alcalá, B.S.

503-913-3691alcalaf@ohsu.edu

Graham Harker, MPH

503-418-2601harkerg@ohsu.edu

Principal Investigator:

Martina Mancini, PhD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • Tactile cueing
  • Gait
  • Turning
  • Cortical activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-12-17.