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

NCT ID: NCT06430151

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-16
• Study Completion Date: 2024-12-16

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CUE1 users

Group Type: EXPERIMENTAL

CUE1

Intervention Type: DEVICE

Sternal worn focused vibrotactile stimulation and cueing device

Interventions

CUE1

Sternal worn focused vibrotactile stimulation and cueing device

Intervention Type: DEVICE

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr Alistair Mackett

OTHER

Sponsor Role: lead

Responsible Party

Dr Alistair Mackett

Consultant Geriatrician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Cambridge University Hospitals Foundation Trust

Cambridge, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Alistair J Mackett, MBBS

Role: CONTACT

alistair.mackett1@nhs.net

01223 217483

Facility Contacts

Alistair J Mackett, MBBS

Role: primary

01223 217483

Other Identifiers

A096551

Identifier Type: -

Identifier Source: org_study_id