Developmental DyslexiaFMRI-DCD-DDNCT02393729
Functional MRI Study in Children With a Developmental Coordination Disorder (DCD) and/or Developmental Dyslexia (DD)
A study testing Neuropsychological assessment and MRI Study in people with Developmental Dyslexia and Developmental Coordination Disorder, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Dyslexia, Developmental Coordination Disorder
- What is being tested?
- Neuropsychological assessment and MRI Study
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Being tested
- Neuropsychological assessment, MRI Study
- Medical subject headings
- Dyslexia, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessmentBehavioural
The neuropsychological assessment will include an assessment of:
- Intellectual ability
- Laterality
- Reading Skills
- Motor skills
- Oral Language
- Attention
- Child's behaviour
MRI StudyOther
Also called structural and functional MRI
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).
| Study group | Role | What they receive |
|---|---|---|
| children with DCD | Other | Children with Developmental Coordination Disorder (DCD) will have neuropsychological assessment and MRI study Receives: Behavioral: Neuropsychological assessment; Other: MRI Study |
| children with DD | Other | Children with Developmental Dyslexia (DD) will have neuropsychological assessment and MRI study Receives: Behavioral: Neuropsychological assessment; Other: MRI Study |
| children with DCD + DD | Other | Neuropsychological assessment and MRI study Receives: Behavioral: Neuropsychological assessment; Other: MRI Study |
| control children | Other | Neuropsychological assessment and MRI study Receives: Behavioral: Neuropsychological assessment; Other: MRI Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startJan 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Developmental DyslexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Chaix, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393729
- Sponsor's protocol ID
- 10 155 02
- Other IDs
- N°RCB : 2010-A00909-30
- Acronym
- FMRI-DCD-DD
- Status last verified
- May 2017
- First submitted
- 13 Mar 2015
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
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 27546352Biotteau 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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02393729
- Acronym / sponsor ID
- FMRI-DCD-DD / 10 155 02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| children with DCD | Other | Behavioral: Neuropsychological assessment, Other: MRI StudyChildren with Developmental Coordination Disorder (DCD) will have neuropsychological assessment and MRI study |
| children with DD | Other | Behavioral: Neuropsychological assessment, Other: MRI StudyChildren with Developmental Dyslexia (DD) will have neuropsychological assessment and MRI study |
| children with DCD + DD | Other | Behavioral: Neuropsychological assessment, Other: MRI StudyNeuropsychological assessment and MRI study |
| control children | Other | Behavioral: Neuropsychological assessment, Other: MRI StudyNeuropsychological assessment and MRI study |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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).
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological assessmentThe neuropsychological assessment will include an assessment of: * Intellectual ability * Laterality * Reading Skills * Motor skills * Oral Language * Attention * Child's behaviour | Behavioural | children with DCD, children with DCD + DD, children with DD, control children |
| MRI StudyAlso: structural and functional MRIIt 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 | children with DCD, children with DCD + DD, children with DD, control children |
Primary outcome
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.
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 secondary outcome
The performance of subjects
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Results publication: PubMed 27546352Biotteau 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 publication: PubMed 26729293Biotteau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Chaix, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological assessment and MRI Study in people with Developmental Dyslexia and Developmental Coordination Disorder, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in the level of brain activity (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02393729, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.