ClinicalTrials.gg
Sign In
Status unknownNCT06430151Updated May 28, 2024

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

An interventional study of CUE1 in Parkinson Disease, sponsored by Dr Alistair Mackett. Status unknown at 1 site in United Kingdom. Open to participants aged 60 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-05-28.

Sponsored by Dr Alistair Mackett · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
60 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson Disease

Browse trials for

03

In context

Parkinson Disease

4,585 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

This is the only study on the registry with Dr Alistair Mackett as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    CUE1 users

    Device: CUE1

Interventions

  • DeviceCUE1

    Sternal worn focused vibrotactile stimulation and cueing device

06

What researchers measure

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.

    Time frame: 4 weeks

Secondary outcomes

  1. 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.

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Cambridge University Hospitals Foundation Trust
    Cambridge, United Kingdom
    • Alistair J Mackett, MBBS · Contact · 01223 217483
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — No plans to make IPD available to other researchers

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Nov 2024, 6 months after the start.

Of 1,296 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 6 months is below that.

Counting every sponsor, half of 1,369 studies reached it within 24 months; a quarter within 11 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2024
First posted
May 28, 2024
StartActual
May 16, 2024
Primary completionEst.
Nov 16, 2024
CompletionEst.
Dec 16, 2024
Last update
May 28, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06430151
Lead sponsor
Dr Alistair Mackett
Responsible party
Dr Alistair Mackett (Consultant Geriatrician, Cambridge University Hospitals NHS Foundation Trust) — Sponsor-investigator
First posted
May 28, 2024
Start date
May 16, 2024
Primary completion
Nov 16, 2024 (estimated)
Completion
Dec 16, 2024 (estimated)
Last update
May 28, 2024

Study contacts

Alistair J Mackett, MBBS
Contact
alistair.mackett1@nhs.net
01223 217483

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Parkinson Disease →

Start the discussion