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

NCT06430151 | Recruiting

• 1 other identifier: A096551
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To undertake standardized, validated measurements of motor function with use of the CUE1 device

  4 weeks

Study Arms (1)

CUE1 users

EXPERIMENTAL

Device: CUE1

Interventions

CUE1 DEVICE

Sternal worn focused vibrotactile stimulation and cueing device

CUE1 users

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Alistair Mackett: lead

Study Sites (1)

Cambridge University Hospitals Foundation Trust

Cambridge, United Kingdom

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Alistair J Mackett, MBBS

CONTACT

01223 217483; alistair.mackett1@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Geriatrician

Model Details: Useability and acceptability study of a vibrotactile stimulation device

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 28, 2024
• Study Start: May 16, 2024
• Primary Completion: November 16, 2024
• Study Completion: December 16, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)