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

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ClinicalTrials.gov Identifier: NCT04174820
Recruitment Status : Not yet recruiting
First Posted : November 22, 2019
Last Update Posted : November 22, 2019
Sponsor:
Collaborators:
Assistance Publique - Hôpitaux de Paris
National Cancer Institute, France
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Medulloblastoma, Childhood Healthy Volunteers Fossa Posterior Tumor Low-grade Glioma 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.

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Study Type : Observational
Estimated Enrollment : 145 participants
Observational Model: Case-Control
Time Perspective: Other
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
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022


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




Primary Outcome Measures :
  1. Structural and functional connectives in brain MRI [ Time Frame: 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 :
  1. Dexterity with Box and Blocks test [ Time Frame: One day ]
    Evaluation of the dexterity with Box and Blocks test (number of displaced blocks with each hand).

  2. Dexterity with Nine Hole Peg test [ Time Frame: 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).

  3. The balance and the walk [ Time Frame: One day ]
    Evaluation of the balance and the walk with the walkway (time in seconds for the completion of the walkway).

  4. Language functions [ Time Frame: One day ]
    Evaluation of the language functions with the EXALang tests (lexicology, phonology, oral expression, oral understand, reading ...).

  5. Social cognition functions and the cognitive function: recognition of the affects [ Time Frame: One day ]
    Evaluation with the NEPSY II subtests (total score of 35).

  6. Social cognition functions and the cognitive function: behavioural executive functions [ Time Frame: One day ]
    Evaluation with the BRIEF test (86 items for parents).

  7. Social cognition functions and the cognitive function: flexibility [ Time Frame: One day ]
    Evaluation with the FEE test (completion time and number of errors).

  8. Social cognition functions and the cognitive function: perceptual and verbal reasoning [ Time Frame: One day ]
    Evaluation with the WISC V test (number of correct answers).

  9. Patients characteristics [ Time Frame: One day ]
    Age, sociodemographics, personal and cancer history.

  10. Quality of life of patients: PedsQL questionnaire [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04174820


Contacts
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Contact: Denise Jolivot, MD 33-(0)2-41-35-58-08 DeJolivot@chu-angers.fr
Contact: Sybille Lazareff, CRA 33-(0)2-41-35-33-42 SyLazareff@chu-angers.fr

Locations
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France
Hôpital Necker
Paris, France, 75015
Contact: Stéphanie Puget, MD    +33 1 44 49 40 25    stephanie.puget@aphp.fr   
Institut Curie
Paris, France, 75231
Contact: François Doz, MD    +33 1 44 32 45 50    francois.doz@curie.fr   
Hôpitaux Saint-Maurice
Saint-Maurice, France
Contact: Mathilde Chevignard, MD    +33 1 43 96 63 40    m.chevignard@hopital-saint-maurice.fr   
Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
University Hospital, Angers
Assistance Publique - Hôpitaux de Paris
National Cancer Institute, France
Investigators
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Principal Investigator: Mickaël Dinomais, MD University Hospital, Angers

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT04174820    
Other Study ID Numbers: 49RC18_0010
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Angers:
Functional Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Infratentorial Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Medulloblastoma
Glioma
Central Nervous System Diseases
Nervous System Diseases