CClinicalTrials.gg
CompletedNCT02393729FMRI-DCD-DDUpdated May 12, 2017

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

An interventional study of Neuropsychological assessment and MRI Study in Developmental Dyslexia and Developmental Coordination Disorder, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-12.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Non-randomized
Ages
8 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Developmental Dyslexia
  • Developmental Coordination Disorder
03

In context

Dyslexia

124 studies on the registry are indexed under Dyslexia; 27 are open to participants now.

This study's enrollment of 65 is below the median of 76 across 106 interventional studies indexed under Dyslexia.

Browse Dyslexia studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
65 participants (actual)

Study arms

  • Other
    children with DCD

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

    Behavioral: Neuropsychological assessment · Other: MRI Study

  • Other
    children with DD

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

    Behavioral: Neuropsychological assessment · Other: MRI Study

  • Other
    children with DCD + DD

    Neuropsychological assessment and MRI study

    Behavioral: Neuropsychological assessment · Other: MRI Study

  • Other
    control children

    Neuropsychological assessment and MRI study

    Behavioral: Neuropsychological assessment · Other: MRI Study

Interventions

  • BehavioralNeuropsychological assessment

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

  • OtherMRI 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).

    Also known as: structural and functional MRI

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

  2. 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.

    Time frame: 1 day

Secondary outcomes

  1. 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.

    Time frame: 1 day

07

Study locations

1 site
  • Hôpital des Enfants
    Toulouse, 31073, France
08

References and documents

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. PubMed 27546352 ↗
  • 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. PubMed 26729293 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02393729
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Mar 19, 2015
Start date
Jan 2011
Primary completion
Sep 2013
Completion
Sep 2013
Last update
May 12, 2017

Study contacts

Yves Chaix, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion