Using a non-invasive device to help manage symptoms in people with Parkinson's disease
The Use of the CUE1/CUE1+ Device in People With Idiopathic Parkinson's Disease and Related Disorders: A Feasibility Study
NA · Queen Mary University of London · NCT06174948
This study is testing a new device that uses gentle vibrations to see if it can help people with Parkinson's disease feel better and manage their symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen Mary University of London (other) |
| Locations | 1 site (London) |
| Trial ID | NCT06174948 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of the CUE1 device, which delivers pulsing cueing and vibrotactile stimulation, to alleviate both motor and non-motor symptoms in individuals with Parkinson's disease and related disorders. Participants will wear the device on their sternum or forearm for a duration of 9 weeks to assess its feasibility, safety, tolerability, and effectiveness. The study aims to provide insights into how this non-invasive approach can improve the quality of life for those affected by Parkinson's disease. Previous small case studies have indicated potential benefits of this device.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with a clinical diagnosis of idiopathic Parkinson's disease or related disorders.
Not a fit: Patients with other neurological disorders or significant cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve symptom management for patients with Parkinson's disease and related disorders.
How similar studies have performed: Previous small case studies have shown effectiveness with similar approaches, suggesting potential for success in this larger feasibility study.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
London
- Queen Mary University of London — London, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Cristina Simonet, PhD
- Email: c.simonet@qmul.ac.uk
- Phone: 020 7882 3543
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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