Useability and Acceptability of the CUE1 Device in Older People With Parkinson's Disease
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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alistair J Mackett, MBBS
- Phone Number: 01223 217483
- Email: alistair.mackett1@nhs.net
Study Locations
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-
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Cambridge, United Kingdom
- Recruiting
- Cambridge University Hospitals Foundation Trust
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Contact:
- Alistair J Mackett, MBBS
- Phone Number: 01223 217483
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- Co-existing significant neurological disorder (disabling stroke, multiple sclerosis, dementia, motor neurone disease),
- Atypical parkinsonian disorder diagnosis (e.g. multiple systems atrophy, progressive supranuclear palsy or cortical basal degeneration syndrome)
- co-existing physical impairment or disability causing significant mobility impairment (severe lower limb osteoarthritis)
- trauma or pain to the sternum
- use of other medical device e.g. pacemaker, deep brain stimulator, TENS machine etc
- lacking capacity to consent to the study
- Sensitivity to medical adhesives
- Existing participant in intervention research trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: CUE1 users
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Sternal worn focused vibrotactile stimulation and cueing device
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Useability and acceptability of the CUE1 device in older people with Parkinson's disease
Time Frame: 4 weeks
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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.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To undertake standardized, validated measurements of motor function with use of the CUE1 device
Time Frame: 4 weeks
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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.
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4 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A096551
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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