Functional MRI Study in Children With a Developmental Coordination Disorder (DCD) and/or Developmental Dyslexia (DD) (FMRI-DCD-DD)

May 10, 2017 updated by: University Hospital, Toulouse

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)

All the studies underlined the high frequency of co-morbid associations in specific learning disorders. Understanding the reasons for these associations could enable us to determine the cerebral bases that underlie each disorder. Their frequent association suggests the etiological bases are partly common, it seems logical to turn to explanatory models of various common specific disorders. The model recently proposed by Nicholson & Fawcett (2007) suggests a specific disorder of procedural learning. But the brain networks involved in this learning could be achieved separately. We intend therefore to study the neural networks involved in learning procedural and compare networks recruited among children with specific learning disorder alone or in combination (co-morbidity). The children included in the study have either a Developmental Dyslexia or a Developmental Coordination Disorder, or both. The procedure includes a neuropsychological evaluation and a brain MRI study with a morphological and a functional part. During fMRI the child realizes a automated motor task contrasting with a task involving learning procedural.

Study Overview

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Toulouse, France, 31073
        • Hôpital des Enfants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • Intellectual ability
  • Laterality
  • Reading Skills
  • Motor skills
  • Oral Language
  • Attention
  • Child's behaviour

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

  • Morphological time: this time include the initial acquisition of a sequence of anatomical 3D T1-weighted high-resolution contiguous axial slices and the imaging of diffusion tensor.
  • Functional time: The experimental paradigm is a paradigm as a block with alternating phase of motor and rest conditions. The two motor tasks are: a Learning motor sequence or motor sequence task and Automated motor sequence or AT (automated task).
Other Names:
  • structural and functional MRI
Other: children with DD
Children with Developmental Dyslexia (DD) will have neuropsychological assessment and MRI study

The neuropsychological assessment will include an assessment of:

  • Intellectual ability
  • Laterality
  • Reading Skills
  • Motor skills
  • Oral Language
  • Attention
  • Child's behaviour

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

  • Morphological time: this time include the initial acquisition of a sequence of anatomical 3D T1-weighted high-resolution contiguous axial slices and the imaging of diffusion tensor.
  • Functional time: The experimental paradigm is a paradigm as a block with alternating phase of motor and rest conditions. The two motor tasks are: a Learning motor sequence or motor sequence task and Automated motor sequence or AT (automated task).
Other Names:
  • structural and functional MRI
Other: children with DCD + DD
Neuropsychological assessment and MRI study

The neuropsychological assessment will include an assessment of:

  • Intellectual ability
  • Laterality
  • Reading Skills
  • Motor skills
  • Oral Language
  • Attention
  • Child's behaviour

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

  • Morphological time: this time include the initial acquisition of a sequence of anatomical 3D T1-weighted high-resolution contiguous axial slices and the imaging of diffusion tensor.
  • Functional time: The experimental paradigm is a paradigm as a block with alternating phase of motor and rest conditions. The two motor tasks are: a Learning motor sequence or motor sequence task and Automated motor sequence or AT (automated task).
Other Names:
  • structural and functional MRI
Other: control children
Neuropsychological assessment and MRI study

The neuropsychological assessment will include an assessment of:

  • Intellectual ability
  • Laterality
  • Reading Skills
  • Motor skills
  • Oral Language
  • Attention
  • Child's behaviour

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

  • Morphological time: this time include the initial acquisition of a sequence of anatomical 3D T1-weighted high-resolution contiguous axial slices and the imaging of diffusion tensor.
  • Functional time: The experimental paradigm is a paradigm as a block with alternating phase of motor and rest conditions. The two motor tasks are: a Learning motor sequence or motor sequence task and Automated motor sequence or AT (automated task).
Other Names:
  • structural and functional MRI

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

March 13, 2015

First Submitted That Met QC Criteria

March 13, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

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.

Clinical Trials on Developmental Dyslexia

Clinical Trials on Neuropsychological assessment

Subscribe