Useability and Acceptability of the CUE1 Device in Older... | NCT06430151

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

NCT06430151

Sponsor

Dr Alistair Mackett

Status

Unknown status

Last Update Posted

May 28, 2024Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Parkinson Disease

Interventions

CUE1

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 16, 2024Actual

Primary Completion Date

Nov 16, 2024Estimated

Completion Date

Dec 16, 2024Estimated

First Submitted Date

May 16, 2024

First Submission Date that Met QC Criteria

May 21, 2024

First Posted Date

May 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2024

Last Update Posted Date

May 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CUE1 users	Experimental		Device: CUE1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CUE1	Device	Sternal worn focused vibrotactile stimulation and cueing device	CUE1 users

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alistair J Mackett, MBBS	Contact	01223 217483		alistair.mackett1@nhs.net

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cambridge University Hospitals Foundation Trust	Recruiting	Cambridge			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

No plans to make IPD available to other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 24, 2026

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided