ADHDHPNCT02823782
MRI Investigations in Attention Deficit Hyperactivity Disorder (ADHD) and High Potential (HP) Children for a Better Therapeutic Approach
A study testing MRI and neuropsychological assessment in people with ADHD, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Impulsivity and/or hyperactivity in children has become one of the main clinical symptom for consultation, among the most frequent, in general or pediatric medicine. Among the different clinical forms of instability, ADHD appears to be an especially disabling condition for the development of the child, both in… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- MRI and neuropsychological assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Feb 2015
- 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
- Right-hand 4 groups :
- Laminar HP : IQ > 130 and difference between Verbal Comprehension Index (VCI) and Perceptual Reasoning Index (PRI) < 9
- Complex HP : IQ > 130 and difference between VCI and PRI >15
- ADHD : 90 < IQ <110
- Controls : 90 < IQ <110
Who cannot join
- Subjects with any psychiatric disorders except ADHD,
- Subjects with known learning deficits (dyslexia, dysphasia…), attention deficits except for ADHD group
- Subjects with claustrophobia or magnetic devices
- Children with out both parental agreements
Trial locations and contacts
1 site in 1 country.
France1 site
Service de psychiatrie infantile, Hôpital Pierre Wertheimer, 59 Boulevard Pinel
Bron, 69500
About this study
Impulsivity and/or hyperactivity in children has become one of the main clinical symptom for consultation, among the most frequent, in general or pediatric medicine. Among the different clinical forms of instability, ADHD appears to be an especially disabling condition for the development of the child, both in psychomotor, cognitive, emotional and relational aspects. Further, a significant link between ADHD children and some children with High Potential (HP) is observed. HP children show overall ahead cognitive developments compared to children with the same age. In these children, as well as in children with ADHD, an attention vulnerability, psychomotor deficits are noted, as well as emotional and relational deficits that significantly contrasted with some of their cognitive skills. Regarding the HP, the hypothesis is that children with significantly heterogeneous results (Complex) to the Wechsler IV scales are affected by this shift, and hence, by the difficulty of a differential diagnosis with ADHD, unlike those whose intelligence quotient (IQ) results that are more homogeneous (Laminar).
The goal of this work was to study a population of 80 children aged from 8 to 12 years (20 subjects per group) to evaluate the functional and structural brain development by:
- Functional magnetic resonance imaging (fMRI) acquisitions with cognitive stimulations, involving attention, working memory and semantic processing, and emotional stimulations,
- fMRI acquisitions at rest (without activation),
- diffusion tensor magnetic resonance imaging (DTI) acquisitions,
- 3D anatomic acquisitions. Identification of developmental differences in certain cortical brain areas (eg, prefrontal vs parietal), white matter fiber bundles or functional networks preferentially used by one or other of these groups, will help to better understand this disease, and to improve the differential diagnosis in order to implement a more appropriate and personalized management of the patients via new therapeutic strategies.
- Conditions
- ADHD
- Being tested
- MRI, neuropsychological assessment
- Keywords
- Laminar HP, Complex HP
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
MRI and neuropsychological assessment planned for the study for patient and volunteers
neuropsychological assessmentOther
| Study group | Role | What they receive |
|---|---|---|
| Laminar HP | Experimental | Structural and functional MRI markers Receives: Other: MRI; Other: neuropsychological assessment |
| Complex HP | Experimental | Structural and functional MRI markers Receives: Other: MRI; Other: neuropsychological assessment |
| ADHD | Experimental | Structural and functional MRI markers Receives: Other: MRI; Other: neuropsychological assessment |
| Control | Other | Structural and functional MRI markers Receives: Other: MRI; Other: neuropsychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical gray matter (GM) volumes
using the software VBM (Voxel Based Morphometry)
Measured: Day 1
Microstructural connectivity of white matter (WM) fiber bundles
measured by diffusion tensor imaging. Diffusion metrics maps are compared using the software TBSS (Track Based Spatial Statistics),
Measured: Day 1
Functional MRI activity during cognitive tests
using the software SPM (Statistical Parametric Mapping)
Measured: Day 1
Functional connectivity in resting-state fMRI
using the CONN toolbox (functional connectivity toolbox) of SPM (Statistical Parametric Mapping)
Measured: Day 1
Subcortical gray matter (GM) volumes
using the software VBM (Voxel Based Morphometry)
Measured: Day 1
Functional MRI activity during emotional tests
using the software SPM (Statistical Parametric Mapping)
Measured: Day 1
Functional connectivity in resting-state fMRI
using the graph-theory methods
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startMay 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier REVOL, MD, Principal investigator, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823782
- Sponsor's protocol ID
- 2013-805
- Acronym
- HP
- Status last verified
- Jun 2016
- First submitted
- 9 Jun 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Investigations in Attention Deficit Hyperactivity Disorder (ADHD) and High Potential (HP) Children for a Better Therapeutic Approach
- ClinicalTrials.gov ID
- NCT02823782
- Acronym / sponsor ID
- HP / 2013-805
- Conditions
- ADHD
- Keywords
- Laminar HP, Complex HP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 Jul 2016 (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.
Impulsivity and/or hyperactivity in children has become one of the main clinical symptom for consultation, among the most frequent, in general or pediatric medicine. Among the different clinical forms of instability, ADHD appears to be an especially disabling condition for the development of the child, both in psychomotor, cognitive, emotional and relational aspects. Further, a significant link between ADHD children and some children with High Potential (HP) is observed. HP children show overall ahead cognitive developments compared to children with the same age. In these children, as well as in children with ADHD, an attention vulnerability, psychomotor deficits are noted, as well as emotional and relational deficits that significantly contrasted with some of their cognitive skills. Regarding the HP, the hypothesis is that children with significantly heterogeneous results (Complex) to the Wechsler IV scales are affected by this shift, and hence, by the difficulty of a differential diagnosis with ADHD, unlike those whose intelligence quotient (IQ) results that are more homogeneous (Laminar).
The goal of this work was to study a population of 80 children aged from 8 to 12 years (20 subjects per group) to evaluate the functional and structural brain development by:
- Functional magnetic resonance imaging (fMRI) acquisitions with cognitive stimulations, involving attention, working memory and semantic processing, and emotional stimulations,
- fMRI acquisitions at rest (without activation),
- diffusion tensor magnetic resonance imaging (DTI) acquisitions,
- 3D anatomic acquisitions. Identification of developmental differences in certain cortical brain areas (eg, prefrontal vs parietal), white matter fiber bundles or functional networks preferentially used by one or other of these groups, will help to better understand this disease, and to improve the differential diagnosis in order to implement a more appropriate and personalized management of the patients via new therapeutic strategies.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Laminar HP | Experimental | Other: MRI, Other: neuropsychological assessmentStructural and functional MRI markers |
| Complex HP | Experimental | Other: MRI, Other: neuropsychological assessmentStructural and functional MRI markers |
| ADHD | Experimental | Other: MRI, Other: neuropsychological assessmentStructural and functional MRI markers |
| Control | Other | Other: MRI, Other: neuropsychological assessmentStructural and functional MRI markers |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Right-hand 4 groups :
- Laminar HP : IQ > 130 and difference between Verbal Comprehension Index (VCI) and Perceptual Reasoning Index (PRI) < 9
- Complex HP : IQ > 130 and difference between VCI and PRI >15
- ADHD : 90 < IQ <110
- Controls : 90 < IQ <110
Key exclusion criteria (4 listed)
- Subjects with any psychiatric disorders except ADHD,
- Subjects with known learning deficits (dyslexia, dysphasia…), attention deficits except for ADHD group
- Subjects with claustrophobia or magnetic devices
- Children with out both parental agreements
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 |
|---|---|---|
| MRIMRI and neuropsychological assessment planned for the study for patient and volunteers | Other | ADHD, Complex HP, Control, Laminar HP |
| neuropsychological assessment | Other | ADHD, Complex HP, Control, Laminar HP |
Primary outcome
Cortical gray matter (GM) volumes
Time frame: Day 1
using the software VBM (Voxel Based Morphometry)
Microstructural connectivity of white matter (WM) fiber bundles
Time frame: Day 1
measured by diffusion tensor imaging. Diffusion metrics maps are compared using the software TBSS (Track Based Spatial Statistics),
Functional MRI activity during cognitive tests
Time frame: Day 1
using the software SPM (Statistical Parametric Mapping)
Functional connectivity in resting-state fMRI
Time frame: Day 1
using the CONN toolbox (functional connectivity toolbox) of SPM (Statistical Parametric Mapping)
Subcortical gray matter (GM) volumes
Time frame: Day 1
using the software VBM (Voxel Based Morphometry)
Functional MRI activity during emotional tests
Time frame: Day 1
using the software SPM (Statistical Parametric Mapping)
Functional connectivity in resting-state fMRI
Time frame: Day 1
using the graph-theory methods
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 6 Jul 2016.
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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.
Olivier REVOL, MD principal investigator
HCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and neuropsychological assessment in people with ADHD, run by Hospices Civils de Lyon 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 4 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 6 Jul 2016. 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?
Cortical gray matter (GM) volumes (time frame: Day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2016; AzTrials last refreshed its copy on 6 Nov 2026.