Medulloblastoma, ChildhoodCervIRMNCT04174820
Child's Study of the Impact of PF Lesion on Motor Skills, Language, Cognitive Functioning and Social Cognition
An observational study of Medulloblastoma, Childhood and Healthy Volunteers, run by University Hospital, Angers at 5 sites in France.
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… Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Medulloblastoma, Childhood, Healthy Volunteers, Fossa Posterior Tumor
- What is being tested?
- Functional Magnetic Resonance Imaging (fMRI)
- How many people
- 145 participants
- Where
- 5 sitesFrance
- Study dates
- 12 Nov 2020to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- Antecedent of neurologic, metabolic or genetic disease
- Brainstem glioma
- Have a contraindication to a MRI
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU Angers
Angers
Mickaël DINOMAIS, 02 41 35 18 04, mdinomais@les-capucins-angers.fr
- Not yet recruiting
Hôpital Necker
Paris, 75015
Stéphanie Puget, MD, +33 1 44 49 40 25, stephanie.puget@aphp.fr
- Not yet recruiting
Institut Curie
Paris, 75231
François Doz, MD, +33 1 44 32 45 50, francois.doz@curie.fr
- Not yet recruiting
Hôpitaux Saint-Maurice
Saint-Maurice
Mathilde Chevignard, MD, +33 1 43 96 63 40, m.chevignard@hopital-saint-maurice.fr
- Not yet recruiting
Gustave Roussy
Villejuif, 94805
Christelle Dufour, MD, +33 1 42 11 42 47, christelle.dufour@gustaveroussy.fr
About this study
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
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.
Read the 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.
- Being tested
- Functional Magnetic Resonance Imaging (fMRI)
- Keywords
- Functional Magnetic Resonance Imaging
- Medical subject headings
- Medulloblastoma, Infratentorial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Magnetic Resonance Imaging (fMRI)Other
Also called Speech Therapy Tests, Neuropsychological Tests, Balance and Dexterity Tests
list of the tests: Box and Blocks test, Nine Hole Peg test, walkway GAITRite, EXALang tests, NEPSY II subtests, BRIEF, FEE, WISC 5 tests
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Functional Magnetic Resonance Imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
Secondary outcomes (10)
Dexterity with Box and Blocks test
Evaluation of the dexterity with Box and Blocks test (number of displaced blocks with each hand).
Measured: 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).
Measured: 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).
Measured: One day
Language functions
Evaluation of the language functions with the EXALang tests (lexicology, phonology, oral expression, oral understand, reading ...).
Measured: One day
Social cognition functions and the cognitive function: recognition of the affects
Evaluation with the NEPSY II subtests (total score of 35).
Measured: One day
Social cognition functions and the cognitive function: behavioural executive functions
Evaluation with the BRIEF test (86 items for parents).
Measured: One day
Social cognition functions and the cognitive function: flexibility
Evaluation with the FEE test (completion time and number of errors).
Measured: One day
Social cognition functions and the cognitive function: perceptual and verbal reasoning
Evaluation with the WISC V test (number of correct answers).
Measured: One day
Patients characteristics
Age, sociodemographics, personal and cancer history.
Measured: 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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start12 Nov 2020
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medulloblastoma, ChildhoodStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Assistance Publique - Hôpitaux de Paris, National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Mickaël Dinomais, MD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174820
- Sponsor's protocol ID
- 49RC18_0010
- Acronym
- CervIRM
- Status last verified
- Nov 2020
- First submitted
- 8 Nov 2019
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04174820
- Acronym / sponsor ID
- CervIRM / 49RC18_0010
- Keywords
- Functional Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Assistance Publique - Hôpitaux de Paris, National Cancer Institute, France
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Retrospective Low-Grade Glioma | – | Other: Functional Magnetic Resonance Imaging (fMRI)Inclusion of patients with Low-Grade Glioma treated one year ago, with functional Magnetic Resonance Imaging, speech therapy, neuropsychological, balance and dexterity tests |
| Retrospective Medulloblastoma | – | Other: Functional Magnetic Resonance Imaging (fMRI)Inclusion of patients with Medulloblastoma treated one year ago, with functional Magnetic Resonance Imaging, speech therapy, neuropsychological, balance and dexterity tests |
| Prospective patients | – | Other: Functional Magnetic Resonance Imaging (fMRI)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 |
| Control patients | – | Other: Functional Magnetic Resonance Imaging (fMRI)Inclusion of patients without Posterior Fossa Tumor, with functional Magnetic Resonance Imaging, speech therapy, neuropsychological, balance and dexterity tests |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Antecedent of neurologic, metabolic or genetic disease
- Brainstem glioma
- Have a contraindication to a MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Magnetic Resonance Imaging (fMRI)Also: Speech Therapy Tests, Neuropsychological Tests, Balance and Dexterity Testslist of the tests: Box and Blocks test, Nine Hole Peg test, walkway GAITRite, EXALang tests, NEPSY II subtests, BRIEF, FEE, WISC 5 tests | Other | Control patients, Prospective patients, Retrospective Low-Grade Glioma, Retrospective Medulloblastoma |
Primary outcome
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.
10 secondary outcomes
Dexterity with Box and Blocks test
Time frame: One day
Dexterity with Nine Hole Peg test
Time frame: One day
The balance and the walk
Time frame: One day
Language functions
Time frame: One day
Social cognition functions and the cognitive function: recognition of the affects
Time frame: One day
Social cognition functions and the cognitive function: behavioural executive functions
Time frame: One day
Social cognition functions and the cognitive function: flexibility
Time frame: One day
Social cognition functions and the cognitive function: perceptual and verbal reasoning
Time frame: One day
Patients characteristics
Time frame: One day
Quality of life of patients: PedsQL questionnaire
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mickaël Dinomais, MD principal investigator
University Hospital, Angers
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medulloblastoma, Childhood and Healthy Volunteers, run by University Hospital, Angers at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denise Jolivot, MD (33-(0)2-41-35-58-08, DeJolivot@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural and functional connectives in brain MRI (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.