Child's Study of the Impact of PF Lesion on Motor Skills, Language, Cognitive Functioning and Social Cognition

• Conditions: Low-grade Glioma; Medulloblastoma, Childhood; Fossa Posterior Tumor; Healthy Volunteers
• Interventions: Other: Functional Magnetic Resonance Imaging (fMRI)

• Registration Number: NCT04174820
• Lead Sponsor: University Hospital, Angers

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.

Study Timeline

• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-22
• Status Verified: 2020-11
• Study Start: 2020-11-12
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-19
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 145

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective Low-Grade Glioma	Functional Magnetic Resonance Imaging (fMRI)	Inclusion of patients with Low-Grade Glioma treated one year ago, with functional Magnetic Resonance Imaging, speech therapy, neuropsychological, balance and dexterity tests
Retrospective Medulloblastoma	Functional Magnetic Resonance Imaging (fMRI)	Inclusion of patients with Medulloblastoma treated one year ago, with functional Magnetic Resonance Imaging, speech therapy, neuropsychological, balance and dexterity tests
Prospective patients	Functional Magnetic Resonance Imaging (fMRI)	Inclusion of prospective patients with an indication to surgery of a Posterior Fossa Tumor, with evaluation of post-operative mutism and then one year after the end of mutism, an evaluation with functional Magnetic Resonance Imaging, speech therapy, neuropsychological, balance and dexterity tests
Control patients	Functional Magnetic Resonance Imaging (fMRI)	Inclusion of patients without Posterior Fossa Tumor, with functional Magnetic Resonance Imaging, speech therapy, neuropsychological, balance and dexterity tests

Primary Outcome Measures

Name	Time	Method
Structural and functional connectives in brain MRI	One day	Review and compare, in MRI, the structural and functional cerebellar-hemispheric connectives. The primary endpoint the analysis of fMRI brain mapping in accordance to the relations with the motor functions (balance and dexterity), cognitive, behavioral/social cognition and language after treatment for a child's posterior fossa tumor (with or without posterior fossa syndrome) and, in comparison with matched control group on age, sex and level study. The MRI data will be the subject of a specific statistical treatment, via dedicated software, which will be implemented under the control of the investigators who have conducted such an fMRI analysis in previous studies. Various brain mapping can be established from the data collected. It may include statistical comparisons between different preselected regions, and different experimental conditions, or correlation studies between brain activation and clinical parameters.

Secondary Outcome Measures

Name	Time	Method
Social cognition functions and the cognitive function: recognition of the affects	One day	Evaluation with the NEPSY II subtests (total score of 35).
Social cognition functions and the cognitive function: flexibility	One day	Evaluation with the FEE test (completion time and number of errors).
Dexterity with Box and Blocks test	One day	Evaluation of the dexterity with Box and Blocks test (number of displaced blocks with each hand).
The balance and the walk	One day	Evaluation of the balance and the walk with the walkway (time in seconds for the completion of the walkway).
Language functions	One day	Evaluation of the language functions with the EXALang tests (lexicology, phonology, oral expression, oral understand, reading ...).
Social cognition functions and the cognitive function: behavioural executive functions	One day	Evaluation with the BRIEF test (86 items for parents).
Dexterity with Nine Hole Peg test	One day	Evaluation of the dexterity with Nine Hole Peg test (sum of time of realization of the test in seconds and number of displaced pegs).
Social cognition functions and the cognitive function: perceptual and verbal reasoning	One day	Evaluation with the WISC V test (number of correct answers).
Patients characteristics	One day	Age, sociodemographics, personal and cancer history.
Quality of life of patients: PedsQL questionnaire	One day	Comparison of score of Quality of Life questionnaire (PedsQL 4.0: Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) between the four groups of the study. The Quality of Life questionnaire PedsQL 4.0 is composed of 23 items comprising 4 dimensions. Items are reversed scored and linearly transformed to a 0-100 scale. In order to get a total score we must sum all the items scores over the number of items answered on all the scales. If more than 50% of the items in the scale are missing, the scale scores should not be computed.

Trial Locations

Locations (5)

Hôpital Necker; 🇫🇷 Paris, France

Institut Curie; 🇫🇷 Paris, France

Hôpitaux Saint-Maurice; 🇫🇷 Saint-Maurice, France

Gustave Roussy; 🇫🇷 Villejuif, France

CHU Angers; 🇫🇷 Angers, France