Useability and Acceptability of the CUE1 Device in Older People With Parkinson's Disease

Not Applicable

Recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT06430151
• Lead Sponsor: Dr Alistair Mackett

Brief Summary

The CUE1 device is a non-invasive wearable device for people with Parkinson's Disease (PD) approved for sale in the UK. The CUE1 device utilises two established methods to improve motor symptoms in PD, namely pulsed cueing and vibrotactile stimulation. Many people with PD wish to explore non-pharmacological interventions as an adjunct to manage their motor symptom.

Study design and eligibility: This feasibility study is to establish whether the CUE1 device is a useable and acceptable device for older people with PD. 20-25 participants aged \>60 years with PD will be recruited from a movement disorder service to the study.

Methodology: Participants will undertake baseline assessments of motor symptoms and quality of life with a PD nurse assessor in their own home. Following this the CUE1 device will be fitted and repeat assessments of motor symptoms will take place after 20 minutes. The participants will complete a daily diary of useability and acceptability for 4 weeks. A second visit will occur at 4 weeks with the same PD nurse assessor where the final set of motor symptom and quality of life assessments will be completed.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-16
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28
• Primary Completion: 2024-11-16
• Study Completion: 2024-12-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Individuals under the care of a Cambridge University Hospitals Foundation Trust movement disorder service with an established clinical diagnosis of Parkinson's disease based on the UK Brain bank criteria

Exclusion Criteria

1. Co-existing significant neurological disorder (disabling stroke, multiple sclerosis, dementia, motor neurone disease),
2. Atypical parkinsonian disorder diagnosis (e.g. multiple systems atrophy, progressive supranuclear palsy or cortical basal degeneration syndrome)
3. co-existing physical impairment or disability causing significant mobility impairment (severe lower limb osteoarthritis)
4. trauma or pain to the sternum
5. use of other medical device e.g. pacemaker, deep brain stimulator, TENS machine etc
6. lacking capacity to consent to the study
7. Sensitivity to medical adhesives
8. Existing participant in intervention research trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Useability and acceptability of the CUE1 device in older people with Parkinson's disease	4 weeks	Participants' completion of a patient diary which will collect safety, tolerability, useability, and efficacy reports of the device over the study period. Participants will also complete a Patient Global Impression of Change (PGI-C) questionnaire at the end of the study.

Secondary Outcome Measures

Name	Time	Method
To undertake standardized, validated measurements of motor function with use of the CUE1 device	4 weeks	Completion of validated motor scores during the study period to evaluate feasibility of the data collection method for motor symptom change. Any signals of improvement in motor scores would potentially justify larger randomised controlled studies to evaluate this systematically.

Trial Locations

Locations (1)

Cambridge University Hospitals Foundation Trust; 🇬🇧 Cambridge, United Kingdom