Clinical trial NCT06430151: Useability and Acceptability of the CUE1 Device in Older People With Parkinson's Disease
Official title: Useability and Acceptability of the CUE1 Device in Older People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Useability and acceptability study of a vibrotactile stimulation device
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Useability and acceptability of the CUE1 device in older people with Parkinson's disease
timeFrame: 4 weeks
Secondary outcomes:
measure: To undertake standardized, validated measurements of motor function with use of the CUE1 device
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals Foundation Trust
Study officials:
References: