Tests a worn device for Parkinson's and related movement disorders
Tests a worn vibration device in adults with Parkinson's and related movement disorders.
Key facts
- Who runs it
- Queen Mary University of London
- Where
- London, United KingdomSee the site
- Trial code
- Registry title
- The Use of the CUE1/CUE1+ in People With Parkinson's Disease and Related Disorders
- Status
- Recruiting
- People taking part
- 70 people, planned
- Started
- 25 Mar 2024
- Planned end
- 31 Mar 2025
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- CUE1 non-invasive device
- CUE1+ device active vs sham CUE1+ device
- Record updated
- 21 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Parkinson's disease or a related movement disorder, to test a wearable device called CUE1 at home for 9 weeks.
- Age
- Over 18 years old.
- Sex
- All sexes can join.
- Disease stage
- A clinical diagnosis of idiopathic Parkinson's disease or a related disorder: progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration, vascular Parkinsonism, atypical dystonias, tremor disorders or orthostatic tremor.
- Earlier treatment
- If you take medicines for Parkinson's or a related disorder, the dose must have been stable for the last three months.
Main reasons for not taking part
- Other neurological, metabolic or autoimmune disorders that affect movement, balance and gait
- Dementia, Alzheimer's or other cognitive impairment
- Implanted metallic or electronic devices
- Severe hearing loss, poor eyesight or visual disturbances
- Skin conditions or an open wound where the device is worn
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Adults over 18 years old
- Clinical diagnosis of idiopathic PD and related disorders including progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD), and vascular Parkinsonism (VaP) as well as atypical dystonias and tremor disorders and Orthostatic Tremor (OT)
- willing to participate and written consent provided after read the participant information sheet
Who cannot take part
- other neurological disorders excluding idiopathic PD, related disorders such PSP, MSA, CBD, and VaP as well as atypical dystonias and tremor disorders, affecting movement, balance and gait
- metabolic or autoimmune disorders affecting movement, balance and gait
- acute orthopaedic disorders influencing balance control and gait
- audiovestibular disorders including severe hearing loss
- clinical diagnosis of cognitive impairment including dementia or Alzheimer's
- Mental impairments (illusions, hallucinations, impulse control disorders) (self-reported); Technical contraindications related to CUE1 device:
- hypersensitivity to vibrotactile stimulation
- skin conditions and/or open wound in the area of where the device will be positioned (e.g., sternum) if taking medicines for PD or related disorder, then on stable dose of treatment for the last three months
- Individuals with:
- visual disturbances, poor eyesight
- not able to provide written consent form to participate
- implanted metallic or electronic devices usage
Where in United Kingdom
- Queen Mary University of LondonLondon, United KingdomContact: Viktoria Azoidou, PhDTaking people
About the trial
What the trial wants to find out
People with Parkinson's disease (PD) commonly experience a range of both motor (e.g., bradykinesia, rigidity, tremor, and postural instability) and non-motor (e.g., fatigue, psychiatric and behavioural disturbances, autonomic dysfunction, cognitive impairment, sleep dysfunction and olfactory loss) features. Currently, it is challenging to alleviate these symptoms with first-line treatment, the medications such as levodopa. The CUE1 is a non-invasive device, which is approved for sale in the UK market as a Class I low risk device. It is worn on the sternum or other part of the body such as the forearm and attaches to the skin via an adhesive patch which has been dermatologically tested and approved.
Read full original descriptionShow less
The CUE1 delivers pulsing cueing and vibrotactile stimulation to help improve symptoms in people with PD and it has shown to be effective in doing so in previous small case studies. This 9-week feasibility study aims to investigate the feasibility, safety, tolerability and effect of using the CUE1 as an intervention to improve motor and non-motor symptoms in people with PD and related movement disorders. People with clinical diagnosis of idiopathic PD and related disorders including those with progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration, orthostatic tremor and vascular Parkinsonism as well as atypical dystonias and tremor disorders aged over 18 years old who have the capacity to provide a written consent form to take part in the study, will receive as intervention to wear the CUE1 device at home, on daily basis while carrying out their activities of daily living. Participants will also have to attend face-to-face appointments of approximately half a day, to discuss how they are getting on with using the CUE1 and complete questionnaires on their symptoms, walking, balance, and movement tests as well as a participant's clinical diary.
The 2 groups in the trial
- people with Parkinson's disease and related disordersTreatment being tested
Intervention All participants with Parkinson's related disorders and the first 10 participants with Parkinson's will use the CUE1 device as follows: * 1-2/9 weeks in the study: once a day for a continuous duration of 2 hours in the morning, 1 hour after taking the medication (if any) for PD or related disorder, every single day; * 4-5/9 weeks in the study: once a day for a continuous duration of 8 hours, starting from morning, 1 hour after taking the medication (if any) for PD or related disorder, every single day; * 7-8/9 weeks in the study: only at night, through all night, every single night and not during the day at all; 15-20 participants with Parkinson's disease will use the CUE1+ device at loud settings for 12 continuous weeks, as above the participants during weeks 4-5.
Treatment: CUE1 non-invasive device and CUE1+ device active vs sham CUE1+ device
- People with Parkinson's diseaseSham treatment, for comparison
15-20 participants with Parkinson's disease will use the CUE1+ device sat silent settings for 12 continuous weeks, as above the participants during weeks 4-5 and compared to the active CUE1+ intervention with people with Parkinson's disease only as above
Treatment: CUE1+ device active vs sham CUE1+ device
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Use of the CUE1/CUE1+ Device in People With Idiopathic Parkinson's Disease and Related Disorders: A Feasibility Study
- Plain-language title
- Tests a worn device for Parkinson's and related movement disordersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Publications
- Sternum-worn vibrotactile device in Parkinson's disease: a randomised, double-blind, placebo-controlled pilot trial.NPJ Parkinson's disease, 2026
- Record updated
- 21 November 2024