The Use of the CUE1/CUE1+ in People With Parkinson's Disease and Related Disorders

Sponsor
Queen Mary University of London
Study ID
NCT06174948
Status
Recruiting
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Conditions

  • Corticobasal Degeneration
  • Different Types of Tremor Including Essential Tremor
  • Dystonia
  • Multiple System Atrophy
  • Orthostatic Tremor
  • Parkinson's Disease and Parkinsonism
  • Progressive Supranuclear Palsy
  • Vascular Parkinsonism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CUE1 non-invasive device — DEVICE
    This is a 9-week feasibility study which will involve wearing the CUE1 device on a daily basis at participants' homes while they continue their usual activities of daily living (ADL). The CUE1 is a non-invasive medical device which delivers low frequency metronomes like tactile cueing and high frequency focused vibrotactile stimulation. All participants will be using the same pre-programmed settings for the CUE1 device which are: vibration strength delivered at 80%, pulse length 800 milliseconds (ms), and rest length 800ms as set at baseline and will not change. The CUE1 device is attached to the skin via an adhesive patch which has been dermatologically tested and approved. Participants will be provided with the adhesive patches and shown how to use them and the CUE1 device by the research team.
  • CUE1+ device active vs sham CUE1+ device — DEVICE
    30-40 participants with idiopathic Parkinson's disease only will be randomly allocated to one of two interventions groups: one group will use the active CUE1+ device while the other group will use the CUE1+ at silent settings (e.g., sham device). All participants will use their device in the same way which is starting the usage from the morning, within an hour once they took their medications for Parkinson's (if any) and continue using the device for 8 hours, once a day, every day for 12 weeks

Study Details

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. 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.

Key Dates

First listed
Dec 18, 2023
Start date
Mar 25, 2024
Status verified
Nov 2024
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: people with Parkinson's disease and related disorders
    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.
  • Sham Comparator: People with Parkinson's disease
    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

Primary Outcome Measure

Recruitment rate [ Time Frame: 1 minute ]

Central Contacts

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