Clinical trial · Observational
Cerebellar Mutism Syndrome Study
Nordic Study of the Cerebellar Mutism Syndrome in Children With Brain Tumours of the Posterior Fossa
NCT02300766CI-TRIAL-00121704recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infratentorial Neoplasms | Infratentorial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Mutism | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Posterior fossa tumor patients
- description
- Children (0-18 years) with a tumour in the posterior fossa (cerebellum/4th ventricle/brainstem ) requiring surgery or open biopsy at one of the participating centres.
Primary outcomes (1)
- measure
- Development and progress of Cerebellar Mutism Syndrome
- timeFrame
- 1 year after surgery
- description
- 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.
Secondary outcomes (1)
- measure
- Development and progress of reduced speech output
- timeFrame
- 1 year after surgery
- description
- Speech production that is severely reduced and limited to single words or short sentences which can only be elicited after vigorous stimulation
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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. * Informed consent from custodial parent(s) Exclusion Criteria: * None
References
Publications (5)
- DERIVEDLaustsen AF, Fric R, Gronbaek JK, Benes V, Lopez VS, Nestler U, Carai A, Solanki G, Avula S, Malluci C, Nilsson P, Nyman P, Hjort MA, Brandsma R, Hoving E, Bua A, Taborska J, Mudra K, Balazs M, Rutkaiskiene G, Rocka S, Lemiere J, Wilhelmy F, Dorfer C, Sehested A, Juhler M, Mathiasen R. Preoperative hydrocephalus and the risk of postoperative speech impairment following posterior fossa tumour surgery in children: results from a prospective, multinational cohort study. Childs Nerv Syst. 2026 Feb 4;42(1):60. doi: 10.1007/s00381-026-07132-z. PMID 41639295
- DERIVEDLaustsen AF, Gronbaek JK, Fric R, Avula S, Mallucci C, Nilsson P, Nyman P, Hauser P, Mudra K, Kiudeliene R, Rocka S, Hjort MA, Brandsma R, Hoving E, Carai A, Benes V, Taborska J, Dorfer C, Jacobs S, Pavon-Mengual M, Skjoth-Rasmussen J, Schmiegelow K, Sehested A, Mathiasen R, Juhler M. Postoperative speech impairment and cranial nerve deficits in children undergoing posterior fossa tumor surgery with intraoperative MRI - a prospective multinational study. Acta Neurochir (Wien). 2025 Sep 22;167(1):252. doi: 10.1007/s00701-025-06669-3. PMID 40982141
- DERIVEDSarup R, Laustsen AF, Sorensen MK, Mallucci C, Pizer B, Aquilina K, Molinari E, Hjort MA, Fric R, Nyman P, Sabel M, Nilsson P, Matukevicius A, Hauser P, Mudra K, Carai A, Zipfel J, Hoving E, van Baarsen K, IIIrd VB, Peyrl A, Nysom K, Sehested AM, Schmiegelow K, Juhler M, Gronbaek JK, Mathiesen R. Glucocorticoid use in paediatric posterior fossa tumour surgery and the occurrence of postoperative speech impairment. Childs Nerv Syst. 2025 Jul 11;41(1):231. doi: 10.1007/s00381-025-06850-0. PMID 40643729
- DERIVEDLaustsen AF, Avula S, Gronbaek J, Pizer B, Nyman P, Nilsson P, Fric R, Hjort MA, Benes V, Hauser P, Palmafy B, Rutkauskiene G, Wilhelmy F, Brandsma R, Sehested A, Mathiasen R, Juhler M. Tumour volume as a predictor of postoperative speech impairment in children undergoing resection of posterior fossa tumours: a prospective, multicentre study. Acta Neurochir (Wien). 2025 Apr 3;167(1):97. doi: 10.1007/s00701-025-06459-x. PMID 40178678
- DERIVEDWibroe M, Cappelen J, Castor C, Clausen N, Grillner P, Gudrunardottir T, Gupta R, Gustavsson B, Heyman M, Holm S, Karppinen A, Klausen C, Lonnqvist T, Mathiasen R, Nilsson P, Nysom K, Persson K, Rask O, Schmiegelow K, Sehested A, Thomassen H, Tonning-Olsson I, Zetterqvist B, Juhler M. Cerebellar mutism syndrome in children with brain tumours of the posterior fossa. BMC Cancer. 2017 Jun 21;17(1):439. doi: 10.1186/s12885-017-3416-0.