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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06430151
• Other study ID #: A096551
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2024
• Est. completion date: December 16, 2024

Study information

• Verified date: May 2024
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Alistair J Mackett, MBBS
• Phone: 01223 217483
• Email: alistair.mackett1[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 16, 2024
• Est. primary completion date: November 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• CUE1
Sternal worn focused vibrotactile stimulation and cueing device

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals Foundation Trust	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Dr Alistair Mackett

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Useability and acceptability of the CUE1 device in older people with Parkinson's disease	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.	4 weeks
Secondary	To undertake standardized, validated measurements of motor function with use of the CUE1 device	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.	4 weeks