The Use of the CUE1/CUE1+ in People With Parkinson's Disease and Related Disorders
Recruiting · NCT06174948 · Interventional (participants receive a specific treatment) · Lead sponsor: Queen Mary University of London
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- Individuals with:
- other neurological disorders excluding idiopathic PD, related disorders such PSP, MSA, CBD, and VaP as well as atypical dystonias and tremor disorders, affecting movement, balance and gait
- metabolic or autoimmune disorders affecting movement, balance and gait
- acute orthopaedic disorders influencing balance control and gait
- audiovestibular disorders including severe hearing loss
- visual disturbances, poor eyesight
- not able to provide written consent form to participate
- clinical diagnosis of cognitive impairment including dementia or Alzheimer's.
- Mental impairments (illusions, hallucinations, impulse control disorders) (self-reported)
- Technical contraindications related to CUE1 device:
- implanted metallic or electronic devices usage
- hypersensitivity to vibrotactile stimulation
- skin conditions and/or open wound in the area of where the device will be positioned (e.g., sternum) if taking medicines for PD or related disorder, then on stable dose of treatment for the last three months.
Where it is running
1 location listed.
- Queen Mary University of London - London, United Kingdom