MEDIR Medulloblastome

NCT ID: NCT01197924

Last Updated: 2010-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The medulloblastome is a tumour of the child relatively frequent usually sitting in the cerebellum and treated by surgery, radiotherapy and chemotherapy. After the treatment, these children present cognitive disorders and in particular disorders of the working memory associated with a fall with the school performances. By studying a troop of 32 children, we could show that the disorders of the working memory prevail during the handling of information presented visually and with verbal contents. However, the specific engagement of the cerebellum in the tasks of working memory according to the sensory method of presentation (visual or auditive) and the nature (verbal or not verbal) of information to treat vague remainder. Moreover, the anatomical attacks associated with these disorders remain ignored in these children. The best comprehension of the bases anatomo-functional calculuses which underlie their cognitive deficits is essential to develop new strategies of treatment and rehabilitation.

Objectives:

* To describe in IRMf of the common and specific networks engaged during the execution of the tasks of working memory according to the sensory type and the nature of information to be memorized.
* To describe in IRMf the cortical reorganizations necessary to the execution of the mnemic tasks among patients.
* To describe in anatomical IRM and of the tensor of diffusion lesions cérébelleuses and cerebral, cortical and subcortical associated with these disorders.
* To study the correlations radio-private clinics between data IRM and the data neurological and neuropsychological of the children explored according to protocol ONCORAP

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The functional study should make it possible to show the specifically committed networks according to the cognitive tasks. Among patients, the relative difficulty to carry out the tasks of working memory should be accompanied by a recruitment of the dorso-side cortex préfrontal, lower and parietal frontal cortex but also of the median frontal areas such as the additional driving surface, the former cingulum. Moreover, one deterioration of the engagement of the cérébello-cerebral network (left lower parietal cortex and cérébelleux cortex lower right) facilitating the execution of these tasks should be observed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Child Cancer Brain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

healthy volonteer children

paired for the sex and the age

IRMf Bold

Intervention Type OTHER

IRMf BOLD of the working memory

older children followed for a médulloblastome cérébelleux

children followed for a médulloblastome treaty by surgery, radiotherapy and chemotherapy

IRMf Bold

Intervention Type OTHER

IRMf BOLD of the working memory

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IRMf Bold

IRMf BOLD of the working memory

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Old from 8 to 12 years
* Total IQ \> 70 for the participation in the study and/or age développemental 7 years minimum
* Treaties for a médulloblastome after the 6 years age in remission supplements with 6 months a minimum time compared to the end of all the treatments
* Followed within the framework of the protocol of evaluation of the mnemic and attentionnelles after-effects
* Sensory after-effects compatible with the realization of the tasks and good performances at the time of the preceding drive the IRM
* Absence of counter-indication to the IRM
* Absence of catch of méthylphénidate (Ritaline®) for the treatment of disorders attentionnels 48h before the IRM
* Enlightened assent signed by at least one of the two parents or holders of the parental authority and by the child (minor)

Exclusion Criteria

* Agitation or movements of the head at the time the IRM
* Artifacts of magnetic susceptibility in projection of the areas of interest (intracranial haemorrhage, cortical and/or metal remains post-operative) • Bad execution of the cognitive tasks
* Tumoral relapse in the course of protocol
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pédiatrie

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anne A PAGNIER, Doctor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University hospital

Bordeaux, Bordeaux, France

Site Status RECRUITING

Institut d'Hématologie et d'Oncologie Pédiatrique

Lyon, Lyon, France

Site Status RECRUITING

Hôpital Frédéric Joliot Orsay - Hôpital Necker

Paris, Paris, France

Site Status RECRUITING

Institut Curie

Paris, Paris, France

Site Status RECRUITING

University Hospital

Saint-Etienne, Saint Etienne, France

Site Status RECRUITING

Institut Gutave Roussy

Villejuif, Villejuif, France

Site Status RECRUITING

SMAEC

Villeurbanne, Villeurbanne, France

Site Status RECRUITING

UniversityHospitalGrenoble

Grenoble, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Isabelle I SCHIFF

Role: CONTACT

0476762635

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Isabelle I SCHIFF

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

07PHN01

Identifier Type: -

Identifier Source: org_study_id