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

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.

NCT Number	NCT06174948
Lead Sponsor	Queen Mary University of London Collaborators: Barts & The London NHS Trust, Homerton University Hospital
Conditions	Parkinson's Disease and Parkinsonism, Progressive Supranuclear Palsy, Different Types of Tremor Including Essential Tremor, Dystonia, Multiple System Atrophy, Corticobasal Degeneration, Vascular Parkinsonism, Orthostatic Tremor
Enrollment	70 participants
Start Date	2024-03-25
Primary Completion	2025-03-31 (estimated)
Study Completion	2025-03-31 (estimated)
Updated on ClinicalTrials.gov	2024-11-21