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

Primary Purpose

Developmental Dyslexia, Developmental Coordination Disorder

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Neuropsychological assessment

MRI Study

About this trial

This is an interventional other trial for Developmental Dyslexia

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Hôpital des Enfants

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Arm Label

children with DCD

children with DD

children with DCD + DD

control children

Arm Description

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

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

Neuropsychological assessment and MRI study

Outcomes

Primary Outcome Measures

difference in the level of brain activity

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.

The level of brain activity obtained by fMRI

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.

Secondary Outcome Measures

The performance of subjects

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.

Full Information

NCT ID

NCT02393729

First Posted

March 13, 2015

Last Updated

May 10, 2017

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT02393729

Brief Title

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

Acronym

FMRI-DCD-DD

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Developmental Dyslexia, Developmental Coordination Disorder

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

children with DCD

Arm Type

Other

Arm Description

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

Arm Title

children with DD

Arm Type

Other

Arm Description

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

Arm Title

children with DCD + DD

Arm Type

Other

Arm Description

Neuropsychological assessment and MRI study

Arm Title

control children

Arm Type

Other

Arm Description

Neuropsychological assessment and MRI study

Intervention Type

Behavioral

Intervention Name(s)

Neuropsychological assessment

Intervention Description

The neuropsychological assessment will include an assessment of: Intellectual ability Laterality Reading Skills Motor skills Oral Language Attention Child's behaviour

Intervention Type

Other

Intervention Name(s)

MRI Study

Other Intervention Name(s)

structural and functional MRI

Intervention Description

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).

Primary Outcome Measure Information:

Title

difference in the level of brain activity

Description

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.

Time Frame

1 day

Title

The level of brain activity obtained by fMRI

Description

Time Frame

1 day

Secondary Outcome Measure Information:

Title

The performance of subjects

Description

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yves Chaix, MD

Organizational Affiliation

University Hospital, Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital des Enfants

City

Toulouse

ZIP/Postal Code

31073

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

27546352

Citation

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.

Results Reference

result

PubMed Identifier

26729293

Citation

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.

Results Reference

result

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

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