NCT04174820

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
12 months until next milestone

Study Start

First participant enrolled

November 12, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

November 8, 2019

Last Update Submit

November 17, 2020

Conditions

Medulloblastoma, ChildhoodHealthy VolunteersFossa Posterior TumorLow-grade Glioma

Keywords

Functional Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Dexterity with Box and Blocks test

    One day

  • Dexterity with Nine Hole Peg test

    One day

  • The balance and the walk

    One day

  • Language functions

    One day

  • Social cognition functions and the cognitive function: recognition of the affects

    One day

  • +5 more secondary outcomes

Study Arms (4)

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)

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)

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)

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)

Interventions

Functional Magnetic Resonance Imaging (fMRI)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

Also known as: Speech Therapy Tests, Neuropsychological Tests, Balance and Dexterity Tests
Control patientsProspective patientsRetrospective Low-Grade GliomaRetrospective Medulloblastoma

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Angers

Angers, France

RECRUITING

Hôpital Necker

Paris, 75015, France

NOT YET RECRUITING

Institut Curie

Paris, 75231, France

NOT YET RECRUITING

Hôpitaux Saint-Maurice

Saint-Maurice, France

NOT YET RECRUITING

Gustave Roussy

Villejuif, 94805, France

NOT YET RECRUITING

MeSH Terms

Conditions

MedulloblastomaInfratentorial Neoplasms

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuroectodermal Tumors, PrimitiveNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Mickaël Dinomais, MD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Jolivot, MD

CONTACT

33-(0)2-41-35-58-08DeJolivot@chu-angers.fr

Sybille Lazareff, CRA

CONTACT

33-(0)2-41-35-33-42SyLazareff@chu-angers.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 22, 2019

Study Start

November 12, 2020

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)