RecruitingOBSERVATIONAL

Cerebellar Mutism Syndrome Study

This study aims to understand why up to 25% of children develop a condition called Cerebellar Mutism Syndrome (CMS) after having surgery for a brain tumour. CMS causes sudden difficulty or inability to speak, along with muscle weakness and irritability. Brain tumours are a major health concern for children, and this syndrome is a significant problem afterwards. Researchers want to find out the exact reasons why CMS happens, what factors increase a child's risk, how the condition progresses over time, and the most effective treatments. They are collecting information from hundreds of children across several countries to help improve understanding and care for patients who undergo this type of surgery.

At a glance

Status

Recruiting

Sponsor

Rigshospitalet, Denmark

Enrolment target

1,000

Start

01 Oct 2014

Estimated completion

31 Dec 2028

Infratentorial Neoplasms Mutism

What is this study about?

When children have surgery for a brain tumour located at the back of the head (called the posterior fossa), sometimes they can develop a condition known as Cerebellar Mutism Syndrome (CMS). This can be very distressing, as children might suddenly have trouble speaking or become completely unable to speak, along with having weak muscles and feeling irritable. This study wants to understand why this happens in up to a quarter of these children. It's important because brain tumours are unfortunately one of the most common cancers in children, and CMS is a challenging side effect of the treatment.

The main goals of this research are to figure out what causes CMS, what might put a child at higher risk of developing it, how the condition changes over time, and what therapies work best. By gathering lots of information from many children, the researchers hope to build a clearer picture of CMS. This knowledge is crucial for doctors to better predict who might get the syndrome and to develop improved ways to treat or even prevent it.

Ultimately, the findings from this study could lead to better information for families before surgery, more effective support and care for children who develop CMS, and improved treatments that could help children recover more quickly and fully. This is about making sure children have the best possible outcome after such complex brain surgery.

Key takeaways

This study aims to understand a speech problem (CMS) after children's brain tumour surgery.
It's an 'observational' study, meaning no new treatments are given.
Researchers will collect medical information, speech samples, and a blood sample.
The study includes children aged 0-18 having specific brain tumour surgery.
Findings could improve future care for children with CMS.

Who may be eligible?

This study is looking for children who are under 18 years old. They must have been diagnosed with a brain tumour located in the cerebellum, fourth ventricle, or brainstem, which are areas at the back of the brain. The child must be planned to have surgery to remove or biopsy the tumour. This includes children having their first surgery, and also those needing further surgeries for the same type of tumour.

To join, a parent or legal guardian must give their permission for the child to take part in the study. All children meeting these criteria will be considered, as there are no specific reasons that would prevent a child from joining if they fit the main requirements.

The study welcomes both boys and girls of any age up to 18 years old who meet these conditions. The research team wants to include as many children as possible to get a broad understanding of the condition.

Quick self-check

Is your child under 18 years old?
Does your child have a brain tumour in the cerebellum, fourth ventricle, or brainstem?
Is your child planning to have surgery for this tumour (either first time or further surgery)?
Are you, as a parent or guardian, willing to give your permission for your child to join?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child takes part in this study, they won't receive any new medicines or treatments as part of the research – they will have the surgery and care planned by their own doctors. The study aims to collect information about their journey. This means researchers will gather details about your child's medical history before surgery, and then monitor their progress, particularly their speech and movement, at different times after the operation.

Data will be collected at five specific times: before surgery, and then at several points afterwards. This will involve reviewing your child's medical records and imaging scans, and potentially asking them to provide speech samples. A small blood sample will also be taken for genetic tests. All of this information will be stored in a special online database. The total duration of your child's participation will depend on how long the follow-up assessments continue after their surgery.

Potential risks and benefits

Taking part in this study could help us learn much more about Cerebellar Mutism Syndrome, which may lead to better care for children in the future, although your child may not directly benefit. The main risks are the time commitment required for extra checks or providing samples, and the potential for a small amount of discomfort from a blood draw. All identified data will be treated confidentially. Remember, you can withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (30)

Medical University of Vienna
Vienna, Austria· Recruiting
University Hospital Leuven
Leuven, Belgium· Recruiting
Motol University Hospital
Prague, Czechia· Recruiting
Aalborg University Hospital
Aalborg, Denmark· Recruiting
Aarhus University Hospital
Aarhus, Denmark· Recruiting
Rigshospitalet
Copenhagen, Denmark· Recruiting
Odense University Hospital
Odense, Denmark· Recruiting
Helsinki University Central Hospital
Helsinki, Finland· Recruiting
Kuopio University Hospital
Kuopio, Finland· Not yet recruiting
Oulu University Hospital
Oulu, Finland· Not yet recruiting
Tampere University Hospital
Tampere, Finland· Not yet recruiting
Turku University Hospital
Turku, Finland· Not yet recruiting

+18 more sites — see the official record for the full list.

Common questions

What is Cerebellar Mutism Syndrome (CMS)?

CMS is a condition that can happen to children after surgery for a brain tumour. It causes sudden difficulty or inability to speak, along with problems with muscle control and mood changes.

Will my child receive new treatment in this study?

No, your child will receive their standard medical care from their doctors. This study is about observing and collecting information, not giving new treatments.

What information will be collected from my child?

Researchers will gather details about your child's health before and after surgery, including how they speak and move, and take a blood sample for genetic tests.

How long will my child be part of the study?

The study involves collecting information at five different times: before surgery and at several points afterwards. The exact duration of follow-up will vary.

Can I take my child out of the study if we change our mind?

Yes, you have the right to withdraw your child from the study at any time. This will not affect the medical care they receive.

How to find out more

Aske F Laustsen, MD, PhD stud

aske.foldbjerg.laustsen@regionh.dk +45 40218998 Official trial record

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