Improve walking rhythm and balance
- Trial ID
- NCT06174948
- Official Title
- The Use of the CUE1/CUE1+ Device in People With Idiopathic Parkinson's Disease and Related Disorders: A Feasibility Study
- Goal
- Improve walking rhythm and balance
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Queen Mary University of London
- Study Type
- INTERVENTIONAL
- Enrollment
- 70 participants
- Conditions
- Parkinson's Disease and Parkinsonism, Progressive Supranuclear Palsy, Different Types of Tremor Including Essential Tremor, Dystonia, Multiple System Atrophy, Corticobasal Degeneration, Vascular Parkinsonism, Orthostatic Tremor
- Interventions
- CUE1 non-invasive device, CUE1+ device active vs sham CUE1+ device
Summary For Families
The goal is to test whether a wearable tactile cueing device can be used safely and practically, and whether its vibration cues might help the timing of movement, gait and balance in people with Parkinson's and related movement disorders. Participants wear the non-invasive CUE1 or CUE1+ device, usually on the sternum, which delivers short vibrotactile pulses to provide an external rhythm for steps and posture; the trial compares active versus sham CUE1+ and the device is non-drug so it is used alongside stable Parkinson's medications rather than replacing them. The study is looking for adults 18 and older with idiopathic Parkinson's or related conditions such as PSP, MSA, CBD, vascular parkinsonism, atypical dystonias, various tremor disorders and orthostatic tremor, who can give informed consent and have been on a stable dose of Parkinson's medicines for the past three months. People with cognitive impairment or dementia, severe hearing or visual problems, implanted metal or electronic devices, skin issues where the device would sit, or hypersensitivity to vibrotactile stimulation are excluded.
Locations
- Queen Mary University of London, London, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying CUE1 non-invasive device. The goal is to test whether a wearable tactile cueing device can be used safely and practically, and whether its vibration cues might help the timing of movement, gait and balance in people with Parkinson's and related movement disorders. Participants wear the non-invasive CUE1 or CUE1+ device, usually on the sternum, which delivers short vibrotactile pulses to provide an external rhythm for steps and posture; the trial compares active versus sham CUE1+ and the device is non-drug so it is used alongside stable Parkinson's medications rather than replacing them. The study is looking for adults 18 and older with idiopathic Parkinson's or related conditions such as PSP, MSA, CBD, vascular parkinsonism, atypical dystonias, various tremor disorders and orthostatic tremor, who can give informed consent and have been on a stable dose of Parkinson's medicines for the past three months. People with cognitive impairment or dementia, severe hearing or visual problems, implanted metal or electronic devices, skin issues where the device would sit, or hypersensitivity to vibrotactile stimulation are excluded.
- Who can participate?
- Participants must be at least 18 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 1 year.
- 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.