RecruitingNAINTERVENTIONAL

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

This study is investigating a new wearable device called CUE1, which is designed to help people with Parkinson's disease and related conditions. The CUE1 delivers gentle vibrations to help with symptoms such as slow movement, stiffness, and tremors, as well as non-movement issues like tiredness. Participants will wear the CUE1 device daily for nine weeks at home. The study will check if the device is safe, comfortable, and if it helps improve daily life. Researchers are also looking into how well the device works for different symptoms. This is an important step in finding new ways to support people living with these conditions.

At a glance

Status

Recruiting

Phase

Sponsor

Queen Mary University of London

Enrolment target

Start

25 Mar 2024

Estimated completion

31 Mar 2025

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

What is this study about?

Parkinson's disease and similar conditions can cause a wide range of symptoms, both affecting movement and other aspects of daily life. These might include slow movements, stiffness, tremors, and difficulties with balance. People can also experience tiredness, sleep problems, and changes in mood. While there are treatments available, healthcare professionals are always looking for new ways to help manage these symptoms and improve quality of life.

This study is focusing on a device called CUE1. It's a small, non-invasive device that you wear on your body, for example, on your chest or forearm. It works by delivering gentle, pulsed vibrations. The CUE1 is already approved for use in the UK and has shown promising results in smaller studies for helping people with Parkinson's symptoms. This larger study aims to properly check if the CUE1 device is safe, comfortable to use daily, and how much it can help with both movement and non-movement symptoms over a nine-week period.

The researchers want to understand how the CUE1 could fit into daily routines and make a positive difference. By gathering detailed information from participants, they hope to gain a clearer picture of the device's potential benefits and how it might support individuals living with these conditions in the future.

Key takeaways

The study explores a new wearable device (CUE1) for Parkinson's and similar conditions.
The CUE1 delivers gentle vibrations to help with movement and non-movement symptoms.
Participants will wear the device daily for nine weeks and attend study appointments.
The main goals are to check the device's safety, comfort, and effectiveness.
Your participation could help understand new non-drug ways to manage symptoms.
Existing medications should remain stable if you participate.

Who may be eligible?

To join this study, you need to be an adult over 18 years old. You must have received a formal diagnosis of Parkinson's disease or a related condition, such as Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration, or certain types of tremors or dystonia. It's also important that you are willing and able to give your informed consent in writing to participate in the study.

There are certain reasons why you might not be able to join. These include having other unrelated neurological, metabolic, or autoimmune conditions that affect your movement or balance. You also wouldn't be eligible if you have severe hearing or vision problems, or if you have a diagnosis of dementia or severe mental health conditions like hallucinations. If you have any metal or electronic medical implants, skin conditions where the device would be placed, or are highly sensitive to vibrations, you also wouldn't be able to take part. If you're on medication for Parkinson's or related disorders, your dose needs to have been stable for the last three months.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 18 years old?
Do you have a diagnosis of Parkinson's or a related movement disorder (e.g., PSP, MSA, tremor)?
Are you able to agree to take part in writing?
Do you have any metal implants or serious skin conditions where the device would be placed?
Has your medication dose for Parkinson's or similar conditions been stable for the last three months?

Answer every question to see your result.

What does participation involve?

If you join this study, you will wear the CUE1 device at home every day for nine weeks, as part of your usual daily activities. You will also need to attend a few face-to-face appointments, each lasting about half a day. During these visits, you'll discuss how you're getting on with the CUE1, complete questionnaires about your symptoms, and have some tests to check your walking, balance, and movements. You'll also be asked to keep a clinical diary to record your experiences with the device. Your current medications for Parkinson's or related disorders should remain stable throughout the study.

Potential risks and benefits

Participating in this study might offer you some personal benefits, such as a potential improvement in your movement and non-movement symptoms through the use of the CUE1 device. Even if you don't personally benefit, the information gathered from your participation will be very valuable in helping researchers understand if this device can help others living with similar conditions in the future. Potential risks are generally low, as the CUE1 is a low-risk, non-invasive device. There's a chance of minor skin irritation from the adhesive patch or discomfort from the vibrations, though the device has dermatologically tested patches. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Queen Mary University of London
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is the CUE1 device?

The CUE1 is a small, wearable device that delivers gentle vibrations to your body, designed to help improve symptoms for people with Parkinson's and similar conditions.

How long will I need to use the device?

If you join the study, you will wear the CUE1 device daily for a period of nine weeks.

Do I need to change my current medications if I join?

No, you don't need to change your medications. However, your dose of any Parkinson's-related medication must have been stable for three months before joining.

Will I have to travel for this study?

Yes, you will need to attend a few face-to-face appointments, each lasting about half a day, at the study site.

Is the CUE1 device safe?

The CUE1 is approved for sale in the UK as a low-risk medical device. The study will also carefully monitor its safety during the trial.

How to find out more

Cristina Simonet, PhD

c.simonet@qmul.ac.uk 020 7882 3543 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.