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

Healthy Volunteers Clinical Trial

— CervIRM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04174820
• Other study ID #: 49RC18_0010
• Status: Recruiting
• Start date: November 12, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2020
• Source: University Hospital, Angers
• Contact: Denise Jolivot, MD
• Phone: 33-(0)2-41-35-58-08
• Email: DeJolivot[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Fossa Posterior Tumor
• Healthy Volunteers
• Infratentorial Neoplasms
• Low-grade Glioma
• Medulloblastoma
• Medulloblastoma, Childhood

Intervention

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

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	Hôpital Necker	Paris
France	Institut Curie	Paris
France	Hôpitaux Saint-Maurice	Saint-Maurice
France	Gustave Roussy	Villejuif

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Angers	Assistance Publique - Hôpitaux de Paris, National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dexterity with Box and Blocks test	Evaluation of the dexterity with Box and Blocks test (number of displaced blocks with each hand).	One day
Secondary	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
Secondary	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
Secondary	Language functions	Evaluation of the language functions with the EXALang tests (lexicology, phonology, oral expression, oral understand, reading ...).	One day
Secondary	Social cognition functions and the cognitive function: recognition of the affects	Evaluation with the NEPSY II subtests (total score of 35).	One day
Secondary	Social cognition functions and the cognitive function: behavioural executive functions	Evaluation with the BRIEF test (86 items for parents).	One day
Secondary	Social cognition functions and the cognitive function: flexibility	Evaluation with the FEE test (completion time and number of errors).	One day
Secondary	Social cognition functions and the cognitive function: perceptual and verbal reasoning	Evaluation with the WISC V test (number of correct answers).	One day
Secondary	Patients characteristics	Age, sociodemographics, personal and cancer history.	One day
Secondary	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