NCT06174948 The Use of the CUE1/CUE1+ in People With Parkinson's Disease and Related Disorders
| NCT ID | NCT06174948 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Queen Mary University of London |
| Condition | Parkinson's Disease and Parkinsonism |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-03-25 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2024-03-25 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Alastair Noyce, PhD
STUDY DIRECTOR
Queen Mary University of London
Frequently Asked Questions
Who can join the NCT06174948 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson's Disease and Parkinsonism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06174948 currently recruiting?
Yes, NCT06174948 is actively recruiting participants. Contact the research team at c.simonet@qmul.ac.uk for enrollment information.
Where is the NCT06174948 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06174948 clinical trial?
NCT06174948 is sponsored by Queen Mary University of London. The principal investigator is Alastair Noyce, PhD at Queen Mary University of London. The trial plans to enroll 70 participants.
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