The Use of the CUE1/CUE1+ in People With Parkinson's Disease and Related Disorders

NCT06174948 | Recruiting

• 1 other identifier: 333484
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

People with Parkinson's disease (PD) commonly experience a range of both motor (e.g., bradykinesia, rigidity, tremor, and postural instability) and non-motor (e.g., fatigue, psychiatric and behavioural disturbances, autonomic dysfunction, cognitive impairment, sleep dysfunction and olfactory loss) features. Currently, it is challenging to alleviate these symptoms with first-line treatment, the medications such as levodopa. The CUE1 is a non-invasive device, which is approved for sale in the UK market as a Class I low risk device. It is worn on the sternum or other part of the body such as the forearm and attaches to the skin via an adhesive patch which has been dermatologically tested and approved. The CUE1 delivers pulsing cueing and vibrotactile stimulation to help improve symptoms in people with PD and it has shown to be effective in doing so in previous small case studies. This 9-week feasibility study aims to investigate the feasibility, safety, tolerability and effect of using the CUE1 as an intervention to improve motor and non-motor symptoms in people with PD and related movement disorders. People with clinical diagnosis of idiopathic PD and related disorders including those with progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration, orthostatic tremor and vascular Parkinsonism as well as atypical dystonias and tremor disorders aged over 18 years old who have the capacity to provide a written consent form to take part in the study, will receive as intervention to wear the CUE1 device at home, on daily basis while carrying out their activities of daily living. Participants will also have to attend face-to-face appointments of approximately half a day, to discuss how they are getting on with using the CUE1 and complete questionnaires on their symptoms, walking, balance, and movement tests as well as a participant's clinical diary.

Conditions

Parkinson's Disease and Parkinsonism; Progressive Supranuclear Palsy; Different Types of Tremor Including Essential Tremor; Dystonia; Multiple System Atrophy; Corticobasal Degeneration; Vascular Parkinsonism; Orthostatic Tremor

Keywords

CUE1, Parkinson's disease, movement disorders

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  This is a feasibility outcome, the recruitment rate which will be calculated as the percentage of eligible participants enrolled in the study. This will be reported at each follow up appointment at weeks -3, -6 and -9.

  1 minute

• Compliance with interventions

  This is a feasibility outcome, compliance with interventions, which will be reported as the percentage of days completed using the CUE1 device and duration of using the CUE1 device. These will be reported at each follow up appointment at weeks -3, -6 and -9.

  1 minute

• Dropout rate

  This is a feasibility outcome which will report the dropout rate at each follow up appointment at weeks -3, -6 and -9.

  1 minute

• Physical observation

  This is a safety and tolerability outcome which will be assessed by carrying out a physical observation by research team during the face to face appointments of any adverse event occurring as a result of using the adhesive patches. The adverse events in relation to the CUE1 device will be reported in the participants' clinical diary and discussed during the appointments with the research team.

  1 minute

Secondary Outcomes (13)

• Patient's Global Impression of Change (PGI-C) questionnaire

  5 minutes

• Participant's clinical diary

  15 minutes

• Functional Gait Assessment (FGA)

  10 minutes

• Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Motor Part III

  10 minutes

• Timed Up and Go test (TUG)

  5 minutes

Other Outcomes (10)

• Age

  within 1 minute

• Gender

  within 1 minute

• Disease duration

  within 1 minute

Study Arms (2)

people with Parkinson's disease and related disorders

EXPERIMENTAL

Intervention All participants with Parkinson's related disorders and the first 10 participants with Parkinson's will use the CUE1 device as follows: * 1-2/9 weeks in the study: once a day for a continuous duration of 2 hours in the morning, 1 hour after taking the medication (if any) for PD or related disorder, every single day; * 4-5/9 weeks in the study: once a day for a continuous duration of 8 hours, starting from morning, 1 hour after taking the medication (if any) for PD or related disorder, every single day; * 7-8/9 weeks in the study: only at night, through all night, every single night and not during the day at all; 15-20 participants with Parkinson's disease will use the CUE1+ device at loud settings for 12 continuous weeks, as above the participants during weeks 4-5.

Device: CUE1 non-invasive device; Device: CUE1+ device active vs sham CUE1+ device

People with Parkinson's disease

SHAM COMPARATOR

15-20 participants with Parkinson's disease will use the CUE1+ device sat silent settings for 12 continuous weeks, as above the participants during weeks 4-5 and compared to the active CUE1+ intervention with people with Parkinson's disease only as above

Device: CUE1+ device active vs sham CUE1+ device

Interventions

CUE1 non-invasive device DEVICE

This is a 9-week feasibility study which will involve wearing the CUE1 device on a daily basis at participants' homes while they continue their usual activities of daily living (ADL). The CUE1 is a non-invasive medical device which delivers low frequency metronomes like tactile cueing and high frequency focused vibrotactile stimulation. All participants will be using the same pre-programmed settings for the CUE1 device which are: vibration strength delivered at 80%, pulse length 800 milliseconds (ms), and rest length 800ms as set at baseline and will not change. The CUE1 device is attached to the skin via an adhesive patch which has been dermatologically tested and approved. Participants will be provided with the adhesive patches and shown how to use them and the CUE1 device by the research team.

people with Parkinson's disease and related disorders

CUE1+ device active vs sham CUE1+ device DEVICE

30-40 participants with idiopathic Parkinson's disease only will be randomly allocated to one of two interventions groups: one group will use the active CUE1+ device while the other group will use the CUE1+ at silent settings (e.g., sham device). All participants will use their device in the same way which is starting the usage from the morning, within an hour once they took their medications for Parkinson's (if any) and continue using the device for 8 hours, once a day, every day for 12 weeks

Also known as: CUE1+ device sham

People with Parkinson's disease; people with Parkinson's disease and related disorders

Eligibility Criteria

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

You may qualify if:

• Adults over 18 years old
• Clinical diagnosis of idiopathic PD and related disorders including progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD), and vascular Parkinsonism (VaP) as well as atypical dystonias and tremor disorders and Orthostatic Tremor (OT)
• willing to participate and written consent provided after read the participant information sheet.

You may not qualify if:

• Individuals with:
• other neurological disorders excluding idiopathic PD, related disorders such PSP, MSA, CBD, and VaP as well as atypical dystonias and tremor disorders, affecting movement, balance and gait
• metabolic or autoimmune disorders affecting movement, balance and gait
• acute orthopaedic disorders influencing balance control and gait
• audiovestibular disorders including severe hearing loss
• visual disturbances, poor eyesight
• not able to provide written consent form to participate
• clinical diagnosis of cognitive impairment including dementia or Alzheimer's.
• Mental impairments (illusions, hallucinations, impulse control disorders) (self-reported)
• Technical contraindications related to CUE1 device:
• implanted metallic or electronic devices usage
• hypersensitivity to vibrotactile stimulation
• skin conditions and/or open wound in the area of where the device will be positioned (e.g., sternum) if taking medicines for PD or related disorder, then on stable dose of treatment for the last three months.

Sponsors & Collaborators

• Queen Mary University of London: lead
• Barts & The London NHS Trust: collaborator
• Homerton University Hospital: collaborator

Study Sites (1)

Queen Mary University of London

London, EC1M 6BQ, United Kingdom

RECRUITING

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Related Links

• A Pilot Interventional Study on Feasibility and Effectiveness of the CUE1 device in Parkinson's disease-first results in manuscript

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Supranuclear Palsy, Progressive; Dystonia; Multiple System Atrophy; Corticobasal Degeneration; Movement Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias; Primary Dysautonomias; Autonomic Nervous System Diseases

Study Officials

• Alastair Noyce, PhD

  Queen Mary University of London

  STUDY DIRECTOR

Central Study Contacts

Cristina Simonet, PhD

CONTACT

020 7882 3543; c.simonet@qmul.ac.uk

Viktoria Azoidou, PhD

CONTACT

020 7882 3850; v.azoidou@qmul.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The masking only applies to investigation for a subgroup of people with Parkinson's disease (e.g., 30-40 participants) There is no masking for the single group intervention of people with Parkinson's related disorders and the first 10 participants with Parkinson's disease
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Initially, 10 people with idiopathic Parkinson's disease and 10-20 people with related movement disorders are firstly assigned into a single group study to investigate the feasibility, safety and tolerability of the CUE1 device. Then a subgroup of participants (e.g., 30-40 new participants) with idiopathic Parkinson's disease only will be randomly allocated to one of the two intervention Groups; one group will receive the CUE1+ intervention at loud settings while the other at silent settings. The outcome assessor and statistician the group of the participants. Participants will know in which group they are but they do not know which is the active and which the passive intervention. This intervention is the main of this study and is double blind.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 18, 2023
• Study Start: March 25, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

GB (1)