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

NCT ID: NCT04174820

Last Updated: 2020-11-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 145 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-12
• Study Completion Date: 2022-11-01

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.

Conditions

Medulloblastoma, Childhood; Healthy Volunteers; Fossa Posterior Tumor; Low-grade Glioma

Keywords

Functional Magnetic Resonance Imaging

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

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

Functional Magnetic Resonance Imaging (fMRI)

Intervention Type: OTHER

list of the tests: Box and Blocks test, Nine Hole Peg test, walkway GAITRite, EXALang tests, NEPSY II subtests, BRIEF, FEE, WISC 5 tests

Retrospective Medulloblastoma

Inclusion of patients with Medulloblastoma treated one year ago, with functional Magnetic Resonance Imaging, speech therapy, neuropsychological, balance and dexterity tests

Functional Magnetic Resonance Imaging (fMRI)

Intervention Type: OTHER

list of the tests: Box and Blocks test, Nine Hole Peg test, walkway GAITRite, EXALang tests, NEPSY II subtests, BRIEF, FEE, WISC 5 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

Functional Magnetic Resonance Imaging (fMRI)

Intervention Type: OTHER

list of the tests: Box and Blocks test, Nine Hole Peg test, walkway GAITRite, EXALang tests, NEPSY II subtests, BRIEF, FEE, WISC 5 tests

Control patients

Inclusion of patients without Posterior Fossa Tumor, with functional Magnetic Resonance Imaging, speech therapy, neuropsychological, balance and dexterity tests

Functional Magnetic Resonance Imaging (fMRI)

Intervention Type: OTHER

list of the tests: Box and Blocks test, Nine Hole Peg test, walkway GAITRite, EXALang tests, NEPSY II subtests, BRIEF, FEE, WISC 5 tests

Interventions

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

Intervention Type: OTHER

Other Intervention Names

Speech Therapy Tests; Neuropsychological Tests; Balance and Dexterity Tests

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mickaël Dinomais, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

CHU Angers

Angers, , France

Site Status: RECRUITING

Hôpital Necker

Paris, , France

Site Status: NOT_YET_RECRUITING

Institut Curie

Paris, , France

Site Status: NOT_YET_RECRUITING

Hôpitaux Saint-Maurice

Saint-Maurice, , France

Site Status: NOT_YET_RECRUITING

Gustave Roussy

Villejuif, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Denise Jolivot, MD

Role: CONTACT

Phone: 33-(0)2-41-35-58-08

Email: DeJolivot@chu-angers.fr

Sybille Lazareff, CRA

Role: CONTACT

Phone: 33-(0)2-41-35-33-42

Email: SyLazareff@chu-angers.fr

Facility Contacts

Mickaël DINOMAIS

Role: primary

Stéphanie Puget, MD

Role: primary

François Doz, MD

Role: primary

Mathilde Chevignard, MD

Role: primary

Christelle Dufour, MD

Role: primary

Other Identifiers

49RC18_0010

Identifier Type: -

Identifier Source: org_study_id