The use of the CUE1 in Parkinson's disease and related disorders.
Research type
Research Study
Full title
The use of the CUE1 device in people with idiopathic Parkinson's disease and related disorders. A feasibility study.
IRAS ID
333484
Contact name
Alastair Noyce
Contact email
Sponsor organisation
Queen Mary University of London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 29 days
Research summary
Summary or Research
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, 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 four face-to-face appointments of approximately half a day, at weeks -0, -3, -6 and -9 of the study 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.
Summary of Report
Here's the text to copy and paste. It opens with a one-paragraph summary of the two published feasibility studies (with their references from the annex), then presents the Stage 2 pilot RCT results exactly as they appear in your attachment.
Before reporting this study, we note that our team carried out two earlier feasibility studies of the CUE1 device under the same ethics approval (London – Dulwich Research Ethics Committee, reference 23/PR/1526), both of which have already been published. The first was a single-arm, open-label, 9-week pilot in ten people with Parkinson's disease, which assessed feasibility, usability and preliminary effects on motor and non-motor symptoms (Azoidou V, et al. A pilot interventional study on feasibility and effectiveness of the CUE1 device in Parkinson's disease. Parkinsonism Relat Disord. 2025;133:107349). The second was an unblinded, 9-week interventional pilot in ten people with primary orthostatic tremor (a rare condition causing shakiness when standing), which assessed usability, safety, tolerability and effects on balance, mobility and fatigue (Azoidou V, et al. Usability, safety and tolerability of CUE1 vibrotactile device as promising therapeutic approach in orthostatic tremor. Clin Park Relat Disord. 2025;13:100379). Both studies found the device feasible, safe and well tolerated, and are reported in full in those publications. The results presented below relate to the Stage 2 pilot randomised controlled trial.
The last study is a pilot randomised double-blind controlled trial. Parkinson’s disease is a long-term condition that affects movement. People living with Parkinson’s often have problems with walking, balance and stiffness, and many also experience tiredness, poor sleep and low mood. Current medicines help but do not control every symptom, and they can cause side effects. This study tested a small, non-invasive wearable device called CUE1+ (made by Charco Neurotech). The device is worn on the breastbone with a skin-friendly sticky patch and gives gentle, rhythmic vibrations (“vibrotactile cueing”) intended to help movement. Importantly, this device is worn on the body and does not involve any surgery or medication.
This was a pilot randomised controlled trial. “Pilot” means it was a smaller, early study designed mainly to check whether a larger trial would be practical, rather than to prove the device works. “Randomised” means people were placed into one of two groups by chance, like tossing a coin. “Double-blind” and “placebo-controlled” mean that neither the participants nor the researchers assessing them knew who was in which group, and that one group used a dummy (“sham”) device that looked identical but gave no vibration. Fifty adults with Parkinson’s disease took part. Twenty-five were given the active CUE1+ device and twenty-five were given the sham device. Everyone was asked to wear their device for about eight hours a day for twelve weeks, starting about an hour after their morning Parkinson’s medication, and to carry on with their usual treatment. Participants were assessed at the start of the study and again after twelve weeks. The assessments included a standard doctor-rated movement scale (the MDS-UPDRS), walking and balance tests, and questionnaires about quality of life, sleep, mood, fatigue and the person’s own impression of any change. Participants were recruited through Barts Health NHS Trust and Homerton Healthcare NHS Foundation Trust, and all assessments took place at Queen Mary University of London.
The main aim was to see whether the device could be used safely and comfortably at home. It could. Recruitment, compliance (how reliably people used the device) and retention (how many people finished the study) were all good. Forty-six of the fifty participants completed the study; four did not finish (three in the sham group and one in the active group). The device was well tolerated. Two participants (about four in every hundred), one in each group, had mild, short-lived skin irritation from the sticky patch, which settled on its own. There were no serious side effects and no deaths related to the device.
Alongside the main usability aims, we looked at exploratory measures of symptoms and quality of life. “Exploratory” means these results are early signals only and cannot, on their own, prove that the device works. People using the active CUE1+ device tended to do better than those using the sham device on the doctor-rated movement score (the MDS-UPDRS Part III) and on a Parkinson’s quality-of-life questionnaire (the PDQ-39). The difference in the movement score favoured the active device by about 11 points, and the quality-of-life score also favoured the active device. The clearest improvements were in slowness of movement rather than tremor or stiffness. Most of the other measures did not show a clear difference between the two groups.
The CUE1+ device was practical to use at home, safe and well tolerated over twelve weeks. The early signs that it may help movement and quality of life are encouraging, but this was a small pilot study and the dummy device did not vibrate, so we cannot yet say for certain that the device works. A larger, carefully designed trial, ideally using a dummy device that also vibrates, so that the comparison is fairer, is needed to confirm whether CUE1+ genuinely helps people with Parkinson’s.
The study is registered at ClinicalTrials.gov under the identifier NCT06174948 (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06174948&data=05%7C02%7Cdulwich.rec%40hra.nhs.uk%7C505c2b69bfe744f9830a08ded2fb2ee7%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639180173461787026%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=FasYaGADTsSMShv3nmaoTz03czG4d3nrFuEO2NOTY7E%3D&reserved=0), where the results are posted. The study protocol is freely available at https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fdoi.org%252F10.1136%252Fbmjopen-2024-096051.%2FNBTI%2FIUjGAQ%2FAQ%2F36c05f9b-34d2-4929-aa99-a4b1f87f9903%2F1%2FqLMxBqhVme&data=05%7C02%7Cdulwich.rec%40hra.nhs.uk%7C505c2b69bfe744f9830a08ded2fb2ee7%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639180173461805973%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=iC94%2BO3IW%2BbbTnhsaDCLpF2kWX0Cb%2BLkdTD3mQz6n2M%3D&reserved=0REC name
London - Dulwich Research Ethics Committee
REC reference
23/PR/1526
Date of REC Opinion
22 Feb 2024
REC opinion
Further Information Favourable Opinion