MRI Investigations in Attention Deficit Hyperactivity Disorder (ADHD) and High Potential (HP) Children for a Better Therapeutic Approach (HP)
Primary Purpose
ADHD
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
neuropsychological assessment
Sponsored by
About this trial
This is an interventional basic science trial for ADHD focused on measuring Laminar HP, Complex HP
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Service de psychiatrie infantile, Hôpital Pierre Wertheimer, 59 Boulevard Pinel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Other
Arm Label
Laminar HP
Complex HP
ADHD
Control
Arm Description
Structural and functional MRI markers
Structural and functional MRI markers
Structural and functional MRI markers
Structural and functional MRI markers
Outcomes
Primary Outcome Measures
Cortical gray matter (GM) volumes
using the software VBM (Voxel Based Morphometry)
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),
Functional MRI activity during cognitive tests
using the software SPM (Statistical Parametric Mapping)
Functional connectivity in resting-state fMRI
using the CONN toolbox (functional connectivity toolbox) of SPM (Statistical Parametric Mapping)
Subcortical gray matter (GM) volumes
using the software VBM (Voxel Based Morphometry)
Functional MRI activity during emotional tests
using the software SPM (Statistical Parametric Mapping)
Functional connectivity in resting-state fMRI
using the graph-theory methods
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02823782
Brief Title
MRI Investigations in Attention Deficit Hyperactivity Disorder (ADHD) and High Potential (HP) Children for a Better Therapeutic Approach
Acronym
HP
Official Title
MRI Investigations in Attention Deficit Hyperactivity Disorder (ADHD) and High Potential (HP) Children for a Better Therapeutic Approach
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
Laminar HP, Complex HP
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laminar HP
Arm Type
Experimental
Arm Description
Structural and functional MRI markers
Arm Title
Complex HP
Arm Type
Experimental
Arm Description
Structural and functional MRI markers
Arm Title
ADHD
Arm Type
Experimental
Arm Description
Structural and functional MRI markers
Arm Title
Control
Arm Type
Other
Arm Description
Structural and functional MRI markers
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
MRI and neuropsychological assessment planned for the study for patient and volunteers
Intervention Type
Other
Intervention Name(s)
neuropsychological assessment
Primary Outcome Measure Information:
Title
Cortical gray matter (GM) volumes
Description
using the software VBM (Voxel Based Morphometry)
Time Frame
Day 1
Title
Microstructural connectivity of white matter (WM) fiber bundles
Description
measured by diffusion tensor imaging. Diffusion metrics maps are compared using the software TBSS (Track Based Spatial Statistics),
Time Frame
Day 1
Title
Functional MRI activity during cognitive tests
Description
using the software SPM (Statistical Parametric Mapping)
Time Frame
Day 1
Title
Functional connectivity in resting-state fMRI
Description
using the CONN toolbox (functional connectivity toolbox) of SPM (Statistical Parametric Mapping)
Time Frame
Day 1
Title
Subcortical gray matter (GM) volumes
Description
using the software VBM (Voxel Based Morphometry)
Time Frame
Day 1
Title
Functional MRI activity during emotional tests
Description
using the software SPM (Statistical Parametric Mapping)
Time Frame
Day 1
Title
Functional connectivity in resting-state fMRI
Description
using the graph-theory methods
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier REVOL, MD
Organizational Affiliation
HCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de psychiatrie infantile, Hôpital Pierre Wertheimer, 59 Boulevard Pinel
City
Bron
ZIP/Postal Code
69500
Country
France
12. IPD Sharing Statement
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MRI Investigations in Attention Deficit Hyperactivity Disorder (ADHD) and High Potential (HP) Children for a Better Therapeutic Approach
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