Clinical trial NCT04174820: Child's Study of the Impact of PF Lesion on Motor Skills, Language, Cognitive Functioning and Social Cognition
Official title: Child's Study of the Distant Impact of Posterior Fossa Injury on Motor Skills, Language, Cognitive Functioning, and Social Cognition - a Combination of Clinical Assessments and Brain Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Medulloblastoma, Childhood
Healthy Volunteers
Fossa Posterior Tumor
Low-grade Glioma
Keywords: Functional Magnetic Resonance Imaging
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Assistance Publique - Hôpitaux de Paris
name: National Cancer Institute, France
First posted: 2019-11-22
Enrollment: 145
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Case-control study with prospective and retrospective, multicentric recruitment where patients will be included with a low grade glioma of the posterior fossa or a medulloblastoma compared to a healthy volunteers group.

Brief summary: One of the major complications of posterior fossa surgery is Posterior Fossa Syndrome (PFS). This syndrome is due to a possible complication of surgical excision of a tumor of the cerebellum (4th ventricle) and is characterized by transient postoperative mutism, dysarthria, behavioral, and affective disorders, as well as motor disorders. PFS is thought to be related to axonal lesions. The long-term consequences on the cognitive and psychosocial sphere of PFS have been widely documented. On the other hand, the literature concerning the consequences of this syndrome on language is much restricted. Beyond the language, the role of cerebellum would be central in cognition, some authors even comparing it to a great "conductor" who would underlie the learning of most motor and cognitive automatisms.

Detailed description: The physiopathology and the anatomo-functional correlates of motor, cognitive, and language functions after surgery of PF tumors are still rare and little known. The objective of this study is to analyze them via morphometric MRI analysis and functional and structural connectivity in children away from PF surgery, coupled with clinical data analysis.

Eligibility criteria: Inclusion Criteria:

* Patient with a low grade glioma of the posterior fossa or a medulloblastoma
* Healthy volunteers without any tumor in the posterior fossa (control case)
* At one year of the last treatment for the retrospective groups, or patient who have an indication to a surgery of a tumor of the posterior fossa
* Eligibility to a functional MRI
* Informed consent dated and signed by the holder of the parental authority (if minor) or by the patient (if major) to take part in the study
* Affiliated to a Social Security scheme

Exclusion Criteria:

* Antecedent of neurologic, metabolic or genetic disease
* Brainstem glioma
* Have a contraindication to a MRI

Primary outcomes:
measure: Structural and functional connectives in brain MRI
timeFrame: One day
Secondary outcomes:
measure: Dexterity with Box and Blocks test
timeFrame: One day
measure: Dexterity with Nine Hole Peg test
timeFrame: One day
measure: The balance and the walk
timeFrame: One day
measure: Language functions
timeFrame: One day
measure: Social cognition functions and the cognitive function: recognition of the affects
timeFrame: One day
measure: Social cognition functions and the cognitive function: behavioural executive functions
timeFrame: One day
measure: Social cognition functions and the cognitive function: flexibility
timeFrame: One day
measure: Social cognition functions and the cognitive function: perceptual and verbal reasoning
timeFrame: One day
measure: Patients characteristics
timeFrame: One day
measure: Quality of life of patients: PedsQL questionnaire
timeFrame: One day
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Paris
country: France
facility: Hôpital Necker
city: Paris
country: France
facility: Institut Curie
city: Saint-Maurice
country: France
facility: Hôpitaux Saint-Maurice
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: University Hospital, Angers
name: Mickaël Dinomais, MD
role: PRINCIPAL_INVESTIGATOR
References: