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

NCT ID: NCT02393729

Last Updated: 2017-05-12

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Developmental Dyslexia Developmental Coordination Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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children with DCD

Children with Developmental Coordination Disorder (DCD) will have neuropsychological assessment and MRI study

Group Type OTHER

Neuropsychological assessment

Intervention Type BEHAVIORAL

The neuropsychological assessment will include an assessment of:

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

MRI Study

Intervention Type OTHER

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).

children with DD

Children with Developmental Dyslexia (DD) will have neuropsychological assessment and MRI study

Group Type OTHER

Neuropsychological assessment

Intervention Type BEHAVIORAL

The neuropsychological assessment will include an assessment of:

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

MRI Study

Intervention Type OTHER

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).

children with DCD + DD

Neuropsychological assessment and MRI study

Group Type OTHER

Neuropsychological assessment

Intervention Type BEHAVIORAL

The neuropsychological assessment will include an assessment of:

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

MRI Study

Intervention Type OTHER

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).

control children

Neuropsychological assessment and MRI study

Group Type OTHER

Neuropsychological assessment

Intervention Type BEHAVIORAL

The neuropsychological assessment will include an assessment of:

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

MRI Study

Intervention Type OTHER

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).

Interventions

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Neuropsychological assessment

The neuropsychological assessment will include an assessment of:

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

Intervention Type BEHAVIORAL

MRI Study

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).

Intervention Type OTHER

Other Intervention Names

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structural and functional MRI

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yves Chaix, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Hôpital des Enfants

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 27546352 (View on PubMed)

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.

Reference Type RESULT
PMID: 26729293 (View on PubMed)

Other Identifiers

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N°RCB : 2010-A00909-30

Identifier Type: REGISTRY

Identifier Source: secondary_id

10 155 02

Identifier Type: -

Identifier Source: org_study_id

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