NCT06174948

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

Recruiting now NA Last updated 21 November 2024

What this trial tests

NA trial testing CUE1 non-invasive device in Parkinson's Disease and Parkinsonism in 70 participants. Currently enrolling.

Timeline

25 March 2024

Primary endpoint
31 March 2025

31 March 2025

Quick facts

Lead sponsor	Queen Mary University of London
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	70
Start date	25 March 2024
Primary completion	31 March 2025
Estimated completion	31 March 2025
Sites	1 location across United Kingdom

Drugs / interventions tested

• CUE1 non-invasive device
• CUE1+ device active vs sham CUE1+ device

Conditions studied

• Parkinson's Disease and Parkinsonism — all drugs for Parkinson's Disease and Parkinsonism →
• Progressive Supranuclear Palsy — all drugs for Progressive Supranuclear Palsy →
• Different Types of Tremor Including Essential Tremor — all drugs for Different Types of Tremor Including Essential Tremor →
• Dystonia — all drugs for Dystonia →

Sponsor

Queen Mary University of London

Who can join

18 and older, any sex, with Parkinson's Disease and Parkinsonism or Progressive Supranuclear Palsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Non-invasive device to alleviate symptoms in people living with Parkinson's: study protocol for a multicentre phase II double-blind randomised controlled trial.
   Azoidou V, Bhadra E, Rowsell K, Camboe E, et al · · 2025 · cited 1× · PMID 40288787 · DOI 10.1136/bmjopen-2024-096051
2. Usability, safety and tolerability of CUE1 vibrotactile device as promising therapeutic approach in orthostatic tremor.
   Azoidou V, Zirra A, Boyle T, Gallagher D, et al · · 2025 · PMID 40809990 · DOI 10.1016/j.prdoa.2025.100379