CUE1 non-invasive device for Parkinson's (NCT06174948)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- Participants must attend face-to-face appointments of approximately half a day during this 9-week feasibility study.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive); Wearable / at-home monitoring (non-invasive); Walking & movement tests (non-invasive). Confirm the full schedule with the study coordinator.