Clinical Trial: Cerebellar Mutism Syndrome Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Nordic Study of the Cerebellar Mutism Syndrome in Children With Brain Tumours of the Posterior Fossa

Brief Summary: The purpose of this study is to determine why up to 25% of the pediatric patients who have surgery for a tumor in the posterior fossa develops the Cerebellar Mutism Syndrome (CMS). Furthermore the purpose is to explore the clinical course and the best treatment of the syndrome.

Detailed Summary:

Background:

Cancer accounts for 22 % of all deaths among children in Europe and is thus the leading non-traumatic pediatric cause of death. Central nervous system (CNS) tumours constitute 25% of all childhood cancers, and the majority of these are located in the posterior fossa. One of the most troublesome late effects after neurosurgery for such a tumour is the cerebellar mutism syndrome which is seen in up to 25% of the patients. It is characterized by mutism, hypotonia, ataxia and irritability. The exact aetiology, risk factors, clinical course and treatment have yet to be identified. The aim of this study is to accomplish that.

Method:

This is an observational prospective multicentre study that will include a minimum of 500 paediatric patients with posterior fossa CNS tumours from the Nordic countries. Additional countries might be added later once the study is running. The study has started in fall 2014 in 20 centres from 5 Nordic countries. Prior to this a pilot study was performed on 43 Danish adult patients to validate and fine-tune registration procedure. All patients will be treated according to local standards, but clinical data will be collected and imaging will be reviewed centrally.

To calculate the participation rate the annual number of included patients from each country will be compared to the number of registered patients in the cancer registers of the respective country and year.

A blood sample for genetic analysis will be collected from all patients. The patients' neurology and speech functions will be examined both pre-operatively and repeatedly post-operatively, including recording of standardised speech samples. All data will be collected trough a, for
Sponsor: Rigshospitalet, Denmark

Current Primary Outcome: Development and progress of Cerebellar Mutism Syndrome [ Time Frame: 1 year after surgery ]

The development of CMS is determined by a survey developed Robertson et al. The correlation between the risk of developing CMS and different neurosurgical techniques, genomic variants, treatments, tumor types, comorbidities, neuroradiologic findings, handedness and preoperative language status will be explored.


Original Primary Outcome: Same as current

Current Secondary Outcome: Development and progress of reduced speech output [ Time Frame: 1 year after surgery ]

Speech production that is severely reduced and limited to single words or short sentences which can only be elicited after vigorous stimulation


Original Secondary Outcome: Same as current

Information By: Rigshospitalet, Denmark

Dates:
Date Received: November 21, 2014
Date Started: October 2014
Date Completion: October 2018
Last Updated: October 3, 2016
Last Verified: October 2016