FASTigial: Finding Anatomical SubsTrates of neuropsychological outcome in children with posterior fossa tumors (add-on project on the European CMS study)

Recruiting

Conditions: Cerebellar Mutism Syndrome
unable to speak after brain surgery
10029211
10009720

Registration Number: NL-OMON56713

Lead Sponsor: Prinses Máxima Centrum voor Kinderoncologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

- Eligible for European CMS study
- Age 2-18 years at the date of first imaging showing this tumour
- Understanding and speaking of Dutch language by patient and/or parents

Inclusion criteria European CMS study:
- 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.
- Signed Informed consent from custodial parent(s) and/or patient

Exclusion Criteria

- Patients who have had previous surgery of the posterior fossa
- No informed consent

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary aim is to investigate early clinical and neuroradiological<br /><br>predictors of neuropsychological outcome in children with posterior fossa<br /><br>tumors.<br /><br><br /><br>Hypothesis: clinical criteria, CMS symptom severity, and changes<br /><br>inneuroradiological findings over time will predict neuropsychological outcome<br /><br>at 12 months after surgery. For example, youngerage, greater CMS symptom<br /><br>severity, and larger changes in white matter metrics (DTI) and cerebral<br /><br>perfusion (ASL) over time will be associated with poorer neuropsychological<br /><br>outcomes.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary objectives are to identify group differences and changes over time in<br /><br>neuroradiological and neuropsychological measures for children who have higher<br /><br>versus lower CMS symptom severity.<br /><br><br /><br>Hypothesis: patients with higher versus lower CMS symptom severity will have<br /><br>greater pre- and post-surgery damage to the efferent cerebellar pathways (DTI),<br /><br>leading to cerebello-cerebral diaschisis and supratentorial hypoperfusion<br /><br>(ASL). We expect that some neuroradiological deficits will be shown at the<br /><br>pre-surgery phase, but impairments will become more apparent post-surgery. Some<br /><br>children will show recovery over time; however, those with greater CMS symptoms<br /><br>will have slower recovery.</p><br>