CUE1 in PD
Research type
Research Study
Full title
Useability and acceptability of the CUE1 device in older people with Parkinson's Disease
IRAS ID
322408
Contact name
Alistair J Mackett
Contact email
Sponsor organisation
Cambridge University Hospitals Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 27 days
Research summary
Research summary
Rationale: The CUE1 device is a non-invasive wearable device for people with Parkinson's Disease (PD) approved for sale in the UK. The CUE1 device utilises two established methods to improve motor symptoms in PD, namely pulsed cueing and vibrotactile stimulation. Many people with PD wish to explore non-pharmacological interventions as an adjunct to manage their motor symptom.
Study design and eligibility: This feasibility study is to establish whether the CUE1 device is a useable and acceptable device for older people with PD. 20-25 participants aged >60 years with PD will be recruited from a movement disorder service to the study. Methodology: Participants will undertake baseline assessments of motor symptoms and quality of life with a PD nurse assessor in their own home. Following this the CUE1 device will be fitted and repeat assessments of motor symptoms will take place after 20 minutes. The participants will complete a daily diary of useability and acceptability for 4 weeks. A second visit will occur at 4 weeks with the same PD nurse assessor where the final set of motor symptom and quality of life assessments will be completed.Lay summary of study results: Study title Useability and acceptability of the CUE1 device in older people with Parkinson's Disease
Who carried out the research?
The research was conducted at Cambridge University Hospitals NHS Foundation Trust (CUH). CUH was the sponsor of the research. Funding was provided by Charco Neurotech, the manufacturers of the CUE1 device.Public involvement
There was a public participation group consisting of people with Parkinson’s. Some in the group had used the CUE1 device, others had no experience of the device. The participants helped shape the design of the study and the patient information leaflet.Where and when the study took place
The study was conducted in people with Parkinson’s disease who were under the care of a CUH movement disorder clinic. The study ran from 2024 to 2025.Why was the research needed?
Older adults with advanced Parkinson’s Disease (PD) have limited options for the management of motor (mobility) symptoms. Although drug therapy remains the foundation of PD management, older adults are more susceptible to adverse drug reactions. In addition, if the efficacy of medications begins to diminish, older adults are less likely to be eligible for ‘advanced therapies’ including deep brain stimulation. Non-invasive devices potentially offer a lower risk intervention for this unmet need but there is a lack of evidence in older adults.
What were the main questions studied?
To evaluate the usability, and acceptability of a non-invasive, wearable vibrotactile device worn on the chest in older adults with PDWho participated in the study?
Older people with PD (aged over 70 years). 20 participants were recruited to the study. 16 completed the full study.What treatments or interventions did the participants take/receive?
All participants continued on their usual medications for their PD. In addition, they were supplied with a CUE1 device. The CUE1 device is a small, disc shaped device that is applied to the breastbone using a medical adhesive tape and worn during waking hours. The CUE1 vibrates in a regular pattern providing both vibratory stimulation and cueing. Cueing is a timed stimulus (e.g. a noise or a sensation) which may help improve gait in Parkinson’s.What medical problems (adverse reactions) did the participants have?
There were no significant adverse events recorded during the study period. 2 participants reported minor skin irritation on a total of 3 days out of 477 days of data.What happened during the study?
Participants were followed up for 4 weeks. At the start of the 4-week period they were given full training on how to use the CUE1 device and were advised to wear the CUE1 every day during waking hours. Each day, participants were requested to complete a diary regarding the useability and acceptability of the CUE1 device. Before attaching the CUE1 device patients had a number of standardised mobility measurements taken and after 4 weeks these measurements were repeated. The study was primarily aimed at understanding the use of the device and was not designed to understand whether the device improved PD symptoms.What were the results of the study?
Useability: Median daily device use was 7–9 hours with a median charge duration of 10 hours. A five-point scale was used to collect data on the ease of use and comfort of the device. The mean comfort score was 4.8/5, mean ease of use of the device was 4.8/5 and mean ease of adhesive use was 4.7/5 suggesting the device was provided acceptable comfort to the participants and the device was straightforward to use. Only 54% could independently apply the adhesive patch, often requiring caregiver assistance. 0 devices detached during the study period. Minimal skin irritation was recorded. Recorded device malfunction occurred in 18.75% of cases, but the supplied devices for the study pre-commercial prototypes.
Acceptability: 75% of participants reported they would continue to use the device long term. Participants also completed the patient global impression of change scale at the end of the 4-week period. A score of 1 corresponded to very much worse, 4 equalled no change through to 7 equating to very much improved. The mean score for the PGI-C scale was 4.66 and median score 5.5 (range 3-7) suggesting a potential small motor benefit noted by patients during the 4 week follow up period.How has this study helped patients and researchers?
This is the first study conducted in older adults with PD. The results correlate with earlier work in younger people using the CUE1. The data shows the device appears to be safe, acceptable and well tolerated over a short follow up period.Details of any further research planned
A larger randomised controlled trial in multiple centres is planned to evaluate any efficacy of the device in mobility symptoms for people with PD.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
23/EE/0247
Date of REC Opinion
22 Dec 2023
REC opinion
Further Information Favourable Opinion