All studies
RecruitingOBSERVATIONAL

Evaluation of the MuSICCA for Measuring Awareness

This study aims to make sure a new music-based tool, called MuSICCA, is accurate and helpful for assessing children (aged 2-18) who have serious brain injuries, leading to what doctors call 'disorders of consciousness.' These conditions mean a child is awake but has very limited awareness, or is in a coma. Currently, there isn't a good, proven way to measure awareness in children like there is for adults. Getting an accurate idea of a child's awareness is really important. It helps doctors plan the best care, understand if the child is trying to communicate, and make difficult decisions. This research will help create a reliable way to make these important assessments for children.

At a glance

Status
Recruiting
Sponsor
The Children's Trust, United Kingdom
Enrolment target
80
Start
01 Apr 2022
Estimated completion
01 Dec 2027

What is this study about?

This study is about helping children and young people (aged 2 to 18) who have serious brain injuries that affect their awareness. Doctors call these 'disorders of consciousness.' This can include conditions where someone is awake but has very limited awareness (like a minimally conscious state) or a prolonged vegetative state, which means they are awake but show no signs of awareness.

Currently, there isn't a widely accepted and rigorously tested tool to measure awareness in children with these conditions. For adults, doctors use a musical assessment called MATADOC, which has been proven to be accurate and useful. This study wants to see if a similar tool for children, called MuSICCA (Music therapy Sensory Instrument for Cognition, Consciousness and Awareness), works just as well. MuSICCA uses music and different senses (like sight, sound, and touch) to see how children respond.

Finding out a child's true level of awareness is incredibly important. If doctors don't have an accurate way to assess this, it can lead to problems like not getting the right care, missing signs that a child is trying to communicate, or making difficult decisions about their treatment without enough information. This study will help ensure that children with disorders of consciousness get the most accurate assessments possible, leading to better care and understanding of their condition.

Key takeaways

  • The study tests a new music-based tool (MuSICCA) for children with brain injuries.
  • It helps doctors better understand a child's level of awareness.
  • Participation involves up to 7 assessment sessions over a few months.
  • It's for children aged 2-18 with disorders of consciousness.
  • There are no direct medical benefits, but it helps improve future care for children.
  • You can withdraw your child at any time without affecting their care.

Who may be eligible?

This study is looking for children and young people aged between 2 and 18 years old. To be considered, their medical team must suspect they have a disorder of consciousness, and they should be in the process of being evaluated for this diagnosis.

There are some reasons why a child might not be able to participate. These include if they have known hearing or severe vision problems, because the study uses sounds and sights. Also, children with certain seizure conditions, especially those caused by music, or frequent/long seizures, cannot take part. Finally, if English isn't their first language, they would not be eligible for this study.

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.

  1. Is your child between 2 and 18 years old?
  2. Does their medical team suspect a disorder of consciousness?
  3. Is your child currently being investigated for this diagnosis?
  4. Does your child have good enough hearing and vision to respond to cues?
  5. Do they not have frequent or music-triggered seizures?
  6. Is English their primary language?
Answer every question to see your result.

What does participation involve?

If your child takes part, it will involve being observed during special assessment sessions. Over about three years, your child will attend a maximum of seven sessions. Four of these sessions will use the MuSICCA tool, which involves listening to music, seeing things, and feeling touches. Your child will be asked to respond to these things and simple commands. The other three sessions will use other standard assessment tools (CRS-R, CNC, and NCS-R) to measure their responses. Each session will be recorded with audio and video, and any physical responses will be carefully noted.

Before taking part, a researcher will meet with you to explain everything in detail and answer all your questions. You'll receive a detailed information sheet to help you make your decision. Your child's care will not be affected whether you decide to take part or not.

Potential risks and benefits

There are no direct medical benefits to your child from taking part in this study. However, the information gathered will be very important in helping to develop a more accurate way to assess children with disorders of consciousness, which could lead to better care for many children in the future. There are no known physical risks from participating, as the assessments are non-invasive and involve watching your child's responses. You are free to withdraw your child from the study at any time without giving a reason, and this will not affect their medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Children's Healthcare of Atlanta
    Verified postcode
    Atlanta, United States· Recruiting
  • Bethany Children's Health Centre
    Verified postcode
    Bethany, United States· Recruiting
  • The Children's Trust
    Verified postcode
    Tadworth, United Kingdom· Recruiting

Common questions

What is a 'disorder of consciousness'?

It's a serious brain injury where someone is awake but has very limited or no awareness of their surroundings, like being in a coma or a minimally conscious state.

What is the MuSICCA tool?

It's a special assessment that uses music, sounds, visual cues, and touch to see how a child with a brain injury responds and to understand their level of awareness.

Will my child get any special treatment in the study?

No, this study is about assessing awareness, not providing treatment. However, the information gained may help guide future diagnosis and care decisions.

How long will my child be in the study?

Your child will participate in a maximum of seven assessment sessions over perhaps a few weeks or months. The overall data collection for the study is spread over three years.

Do I have to say yes to my child being in the study?

No, you don't have to. It's completely your choice, and saying no will not affect your child's medical care in any way.

How to find out more

Jonathan W Pool, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Evaluation of the MuSICCA for Measuring Awareness…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.