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EUROPEAN STUDY OF THE CEREBELLAR MUTISM SYNDROME (CMS) IN CHILDREN WITH BRAIN TUMOURS OF THE POSTERIOR FOSSA

Recruiting
Conditions
Cerebellar Mutism Syndrome
unable to speak after brain surgery
10029211
10009720
Registration Number
NL-OMON53502
Lead Sponsor
niversity of Copenhagen - Rigshospitalet - Department of Clinical Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
140
Inclusion Criteria

- Age <18 years at the date of first imaging showing this tumour
- Tumour in the cerebellum/4th ventricle/brainstem with intention to treat with
surgical resection or open biopsy. Second and further surgeries are also
included.
- Signed Informed consent from custodial parent(s) and/or patient

Exclusion Criteria

No informed consent

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>To explore the relationship between different surgical methods for the removal<br /><br>of posterior fossa tumours, and relate these to<br /><br>the incidence and clinical course of the CMS (prospective observational study).<br /><br>Hypothesis: Methods that spare the dentate nuclei and their efferents and focus<br /><br>on minimally traumatic techniques lower the<br /><br>risk of developing the CMS by 50%, and lessen its severity and duration by 40%<br /><br>when compared to more invasive tumour<br /><br>removal methods. The risk of getting the CMS is greater after reoperation(<br /><br>s) when compared to primary surgery.</p><br>
Secondary Outcome Measures
NameTimeMethod
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