The Use of the CUE1/CUE1+ Device in People With Idiopathic Parkinson's Disease and Related Disorders: A Feasibility Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults over 18 years old

• Clinical diagnosis of idiopathic PD and related disorders including progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD), and vascular Parkinsonism (VaP) as well as atypical dystonias and tremor disorders and Orthostatic Tremor (OT)

• willing to participate and written consent provided after read the participant information sheet.

Locations
Other Locations
United Kingdom
Queen Mary University of London
RECRUITING
London
Contact Information
Primary
Cristina Simonet, PhD
c.simonet@qmul.ac.uk
020 7882 3543
Backup
Viktoria Azoidou, PhD
v.azoidou@qmul.ac.uk
020 7882 3850
Time Frame
Start Date: 2024-03-25
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 70
Treatments
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
Sponsors
Leads: Queen Mary University of London
Collaborators: Barts & The London NHS Trust, Homerton University Hospital

This content was sourced from clinicaltrials.gov

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