Improve walking with tactile cueing
- Trial ID
- NCT05818189
- Official Title
- Cortical Correlates of Gait in Parkinson's Disease: Impact of Medication and Cueing
- Goal
- Improve walking with tactile cueing
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Oregon Health and Science University
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson Disease
- Interventions
- Personalized tactile cueing, Fixed tactile cueing
Summary For Families
Goal: To understand how Parkinson's medications and rhythmic touch cues change brain activity and walking, so researchers can identify cueing patterns that make gait steadier and less mentally demanding. Approach: Participants wear a small device that gives rhythmic tactile taps to guide step timing, with one mode providing a fixed rhythm and the other adapting the taps to each person’s natural step pattern, while brain activity over the prefrontal cortex is recorded with fNIRS and walking is compared on versus off Parkinson's medication (for example levodopa). Eligibility: Adults 45,85 with mid-stage Parkinson's (Hoehn and Yahr II,III), able to stand and walk two minutes without an aid, MoCA 21 or higher, no deep brain stimulators, severe dyskinesia, or other major neurological or musculoskeletal problems.
Locations
- Oregon Health and Science University, Portland, Oregon, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Personalized tactile cueing. Goal: To understand how Parkinson's medications and rhythmic touch cues change brain activity and walking, so researchers can identify cueing patterns that make gait steadier and less mentally demanding. Approach: Participants wear a small device that gives rhythmic tactile taps to guide step timing, with one mode providing a fixed rhythm and the other adapting the taps to each person’s natural step pattern, while brain activity over the prefrontal cortex is recorded with fNIRS and walking is compared on versus off Parkinson's medication (for example levodopa). Eligibility: Adults 45,85 with mid-stage Parkinson's (Hoehn and Yahr II,III), able to stand and walk two minutes without an aid, MoCA 21 or higher, no deep brain stimulators, severe dyskinesia, or other major neurological or musculoskeletal problems.
- Who can participate?
- Participants must be between 45 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 8 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.