- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02393729
Functional MRI Study in Children With a Developmental Coordination Disorder (DCD) and/or Developmental Dyslexia (DD) (FMRI-DCD-DD)
Functional MRI Study of the Involvement of Cortico-cerebellar and Cortico-striatal Networks in Children With a Developmental Coordination Disorder (DCD) and/or Developmental Dyslexia (DD)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Toulouse, France, 31073
- Hôpital des Enfants
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
These children presenting either a specific disorder in learning to read (developmental dyslexia or DD) type phonological or mixed as defined by World Health Organisation or a Developmental Coordination Disorder (DCD) as defined by Diagnostic and Statistical Manual IV criteria or the association of both disorders (DCD + DD).
Or in the control group:
Children having no neurological or psychiatric disorder, mental retardation with IQ (Intelligence quotient) > 70 and DCD (score> 15 percentile on the Movement ABC) and Dyslexia (reading delay should not exceed 12 months) The age of children included in the study is between 8 and 12 years. The inclusion of subjects from 8 years is justified to have an optimal level of cooperation of the child in the MRI, in order to determine the status of children for reading and the fact that most of validated neuropsychological tests for reading are for the age 8 to 12 years.
Children and their parents must have given their free and informed consent signed. The representative of the child shall be affiliated to a social security scheme.
The children included in the study will be all right handed.
Exclusion criteria:
Mental retardation as defined by DSM IV criteria by an estimated IQ from the Wechsler scales less than 70.
The presence of a Specific Language Impairment (or dysphasia): a score below -2 SD (standard deviation) in at least one of three tests for language assessment is a criterion for exclusion.
The presence of a dyslexia-type surface defined by a specific disorder in learning to read without difficulty for metaphonological tests and/or an exclusive impairment of the addressing reading route (reading irregular words).
Children regularly practicing a musical instrument conferring a high manual dexterity such as piano or guitar.
Children with neurological or psychiatric disorders as epilepsy for example. Children under psychotropic medication such as anticonvulsant. Treatment with methylphenidate is not an exclusion criterion but treatment should be discontinued at least 48 hours before performing MRI. Children with ADHD according to DSM IV criteria.
The presence of a cons-indication for a MRI.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: children with DCD
Children with Developmental Coordination Disorder (DCD) will have neuropsychological assessment and MRI study
|
The neuropsychological assessment will include an assessment of:
It will include a first session of about an hour outside MRI for familiarization with the environment of the MRI. The MRI will then be made after a break of 15 minutes
Other Names:
|
|
Other: children with DD
Children with Developmental Dyslexia (DD) will have neuropsychological assessment and MRI study
|
The neuropsychological assessment will include an assessment of:
It will include a first session of about an hour outside MRI for familiarization with the environment of the MRI. The MRI will then be made after a break of 15 minutes
Other Names:
|
|
Other: children with DCD + DD
Neuropsychological assessment and MRI study
|
The neuropsychological assessment will include an assessment of:
It will include a first session of about an hour outside MRI for familiarization with the environment of the MRI. The MRI will then be made after a break of 15 minutes
Other Names:
|
|
Other: control children
Neuropsychological assessment and MRI study
|
The neuropsychological assessment will include an assessment of:
It will include a first session of about an hour outside MRI for familiarization with the environment of the MRI. The MRI will then be made after a break of 15 minutes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
difference in the level of brain activity
Time Frame: 1 day
|
The difference in the level of brain activity obtained by contrasting the result of the automated task and that task with learning in the same patient-adjusted performance.
|
1 day
|
|
The level of brain activity obtained by fMRI
Time Frame: 1 day
|
The level of brain activity obtained by fMRI will be estimated by the blood flow in milliliters per minute using a standardized procedure and validated specific MRI used and managed entirely by dedicated software (SPM8 - Welcome Department of Cognitive Neurology, London, UK).
The performance adjustment is made in the analysis of the estimated difference in blood flow using a mixed model.
Regions of interest are the primary motor cortex, the supplementary motor area, the pre motor cortex, the striatum and the cerebellum.
These regions will be studied in both hemispheres.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The performance of subjects
Time Frame: 1 day
|
The performance of subjects evaluated in terms of frequency of movements in Hz and the number of erroneous restraints.
The average frequency of movements for each block will be used as a covariate in the statistical analysis.
|
1 day
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Biotteau M, Peran P, Vayssiere N, Tallet J, Albaret JM, Chaix Y. Neural changes associated to procedural learning and automatization process in Developmental Coordination Disorder and/or Developmental Dyslexia. Eur J Paediatr Neurol. 2017 Mar;21(2):286-299. doi: 10.1016/j.ejpn.2016.07.025. Epub 2016 Aug 12.
- Biotteau M, Albaret JM, Lelong S, Chaix Y. Neuropsychological status of French children with developmental dyslexia and/or developmental coordination disorder: Are both necessarily worse than one? Child Neuropsychol. 2017 May;23(4):422-441. doi: 10.1080/09297049.2015.1127339. Epub 2016 Jan 4.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10 155 02
- N°RCB : 2010-A00909-30 (Registry Identifier: ANSM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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