MEDIR Medulloblastome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University Hospital, Grenoble.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01197924
First received: September 7, 2010
Last updated: September 8, 2010
Last verified: September 2010
  Purpose

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

Condition Intervention
Child Cancer Brain
Other: IRMf Bold

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Médulloblastome of the Child and After-effects Cognitive: Study Anatomo-functional by IRM of the Working Memory

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Estimated Enrollment: 80
Study Start Date: October 2007
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
healthy volonteer children
paired for the sex and the age
Other: IRMf Bold
IRMf BOLD of the working memory
older children followed for a médulloblastome cérébelleux
children followed for a médulloblastome treaty by surgery, radiotherapy and chemotherapy
Other: IRMf Bold
IRMf BOLD of the working memory

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

child Treaties for a médulloblastome after the 6 years age

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197924

Contacts
Contact: Isabelle I SCHIFF 0476762635 ISchiff@chu-grenoble.fr

Locations
France
University hospital Recruiting
Bordeaux, France, 33076
Sub-Investigator: Michèle M ALLARD         
Sub-Investigator: Céline C BOUCHN ICHER         
Sub-Investigator: Muriel M BRUN         
Sub-Investigator: Anne A NOTZ CARRERE         
Sub-Investigator: Yves y PEREL         
UniversityHospitalGrenoble Recruiting
Grenoble, France, 38043
Contact: Isabelle I SCHIFF       ISchiff@chu-grenoble.fr   
Sub-Investigator: Alexandre A KRAINIK         
Sub-Investigator: Dominique D PLANTAZ         
Sub-Investigator: Corinne C ARAMARI ALLA         
Sub-Investigator: FANNY F DUBOIS         
Sub-Investigator: CHANTAL C DURAND         
Institut d'Hématologie et d'Oncologie Pédiatrique Recruiting
Lyon, France, 69008
Sub-Investigator: Cécile c CONTER         
Sub-Investigator: DIDIER D FRAPPAZ         
Institut Curie Recruiting
Paris, France, 75231
Sub-Investigator: Isabelle i AERTS         
Sub-Investigator: François F DOZ         
Sub-Investigator: Sylvie S FASOLA         
Sub-Investigator: Jean J MICHON         
Sub-Investigator: Daniel D ORBACH         
Sub-Investigator: Hélène H PACQUEMENT         
Sub-Investigator: GILLES G PALENZUELA         
Sub-Investigator: GUDRUN G SCHLEIERMACHER         
Hôpital Frédéric Joliot Orsay - Hôpital Necker Recruiting
Paris, France, 75015
Sub-Investigator: Lucie L HERTZ PANNIER         
Sub-Investigator: Rodrigo R SEBASTIAN         
University Hospital Recruiting
Saint Etienne, France, 42055
Sub-Investigator: CLAIRE C BERGER         
Sub-Investigator: FABRICE F BARRAL         
Sub-Investigator: CATHERINE C MASSOUBRE         
Sub-Investigator: JEAN LOUIS JL STEPHAN         
Institut Gutave Roussy Recruiting
Villejuif, France, 94805
Sub-Investigator: jacques j Grill         
SMAEC Recruiting
Villeurbanne, France, 69100
Sub-Investigator: Sybille S GONZALEZ         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Anne A PAGNIER, Doctor University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: PAGNIER Anne, Professor, Pédiatrie
ClinicalTrials.gov Identifier: NCT01197924     History of Changes
Other Study ID Numbers: 07PHN01
Study First Received: September 7, 2010
Last Updated: September 8, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
child cancer brain

ClinicalTrials.gov processed this record on April 17, 2014