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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 145

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Recruiting
    • CHU Angers
    • Contact: Mickaël DINOMAIS; Phone Number: 02 41 35 18 04; Email: mdinomais@les-capucins-angers.fr
  • Paris, France, 75015
    • Not yet recruiting
    • Hopital Necker
    • Contact: Stéphanie Puget, MD; Phone Number: +33 1 44 49 40 25; Email: stephanie.puget@aphp.fr
  • Paris, France, 75231
    • Not yet recruiting
    • Institut Curie
    • Contact: François Doz, MD; Phone Number: +33 1 44 32 45 50; Email: francois.doz@curie.fr
  • Saint-Maurice, France
    • Not yet recruiting
    • Hopitaux Saint-Maurice
    • Contact: Mathilde Chevignard, MD; Phone Number: +33 1 43 96 63 40; Email: m.chevignard@hopital-saint-maurice.fr
  • Villejuif, France, 94805
    • Not yet recruiting
    • Gustave Roussy
    • Contact: Christelle Dufour, MD; Phone Number: +33 1 42 11 42 47; Email: christelle.dufour@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective Low-Grade Glioma; Inclusion of patients with Low-Grade Glioma treated one year ago, with functional Magnetic Resonance Imaging, speech therapy, neuropsychological, balance and dexterity tests	Other: Functional Magnetic Resonance Imaging (fMRI); list of the tests: Box and Blocks test, Nine Hole Peg test, walkway GAITRite, EXALang tests, NEPSY II subtests, BRIEF, FEE, WISC 5 tests; Other Names: Speech Therapy Tests; Neuropsychological Tests; Balance and Dexterity Tests
Retrospective Medulloblastoma; Inclusion of patients with Medulloblastoma treated one year ago, with functional Magnetic Resonance Imaging, speech therapy, neuropsychological, balance and dexterity tests	Other: Functional Magnetic Resonance Imaging (fMRI); list of the tests: Box and Blocks test, Nine Hole Peg test, walkway GAITRite, EXALang tests, NEPSY II subtests, BRIEF, FEE, WISC 5 tests; Other Names: Speech Therapy Tests; Neuropsychological Tests; Balance and Dexterity Tests
Prospective patients; 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	Other: Functional Magnetic Resonance Imaging (fMRI); list of the tests: Box and Blocks test, Nine Hole Peg test, walkway GAITRite, EXALang tests, NEPSY II subtests, BRIEF, FEE, WISC 5 tests; Other Names: Speech Therapy Tests; Neuropsychological Tests; Balance and Dexterity Tests
Control patients; Inclusion of patients without Posterior Fossa Tumor, with functional Magnetic Resonance Imaging, speech therapy, neuropsychological, balance and dexterity tests	Other: Functional Magnetic Resonance Imaging (fMRI); list of the tests: Box and Blocks test, Nine Hole Peg test, walkway GAITRite, EXALang tests, NEPSY II subtests, BRIEF, FEE, WISC 5 tests; Other Names: Speech Therapy Tests; Neuropsychological Tests; Balance and Dexterity Tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structural and functional connectives in brain MRI	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.	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dexterity with Box and Blocks test	Evaluation of the dexterity with Box and Blocks test (number of displaced blocks with each hand).	One day
Dexterity with Nine Hole Peg test	Evaluation of the dexterity with Nine Hole Peg test (sum of time of realization of the test in seconds and number of displaced pegs).	One day
The balance and the walk	Evaluation of the balance and the walk with the walkway (time in seconds for the completion of the walkway).	One day
Language functions	Evaluation of the language functions with the EXALang tests (lexicology, phonology, oral expression, oral understand, reading ...).	One day
Social cognition functions and the cognitive function: recognition of the affects	Evaluation with the NEPSY II subtests (total score of 35).	One day
Social cognition functions and the cognitive function: behavioural executive functions	Evaluation with the BRIEF test (86 items for parents).	One day
Social cognition functions and the cognitive function: flexibility	Evaluation with the FEE test (completion time and number of errors).	One day
Social cognition functions and the cognitive function: perceptual and verbal reasoning	Evaluation with the WISC V test (number of correct answers).	One day
Patients characteristics	Age, sociodemographics, personal and cancer history.	One day
Quality of life of patients: PedsQL questionnaire	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.	One day

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Collaborators: Assistance Publique - Hôpitaux de Paris; National Cancer Institute, France
• Investigators: Principal Investigator: Mickaël Dinomais, MD, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2020
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Functional Magnetic Resonance Imaging
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neuroectodermal Tumors, Primitive; Medulloblastoma; Infratentorial Neoplasms
• Other Study ID Numbers: 49RC18_0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No