NCT02393729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

2.7 years

First QC Date

March 13, 2015

Last Update Submit

May 10, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    1 day

  • 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.

    1 day

Secondary Outcomes (1)

  • The performance of subjects

    1 day

Study Arms (4)

children with DCD

OTHER

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

Behavioral: Neuropsychological assessmentOther: MRI Study

children with DD

OTHER

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

Behavioral: Neuropsychological assessmentOther: MRI Study

children with DCD + DD

OTHER

Neuropsychological assessment and MRI study

Behavioral: Neuropsychological assessmentOther: MRI Study

control children

OTHER

Neuropsychological assessment and MRI study

Behavioral: Neuropsychological assessmentOther: MRI Study

Interventions

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

children with DCDchildren with DCD + DDchildren with DDcontrol children

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
children with DCDchildren with DCD + DDchildren with DDcontrol children

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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 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.

You may not qualify if:

  • Mental retardation as defined by DSM IV criteria by an estimated IQ from the Wechsler scales less than 70.
  • 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.
  • The presence of a cons-indication for a MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital des Enfants

Toulouse, 31073, France

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

DyslexiaMotor Skills Disorders

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Yves Chaix, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2015

First Posted

March 19, 2015

Study Start

January 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

May 12, 2017

Record last verified: 2017-05

Locations