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Completed

NCT Number: NCT02823782

MRI Investigations in Attention Deficit Hyperactivity Disorder (ADHD) and High Potential (HP) Children for a Better Therapeutic Approach

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de psychiatrie infantile, Hôpital Pierre Wertheimer, 59 Boulevard Pinel

Bron, 69500, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Other

MRI and neuropsychological assessment planned for the study for patient and volunteers

Neuropsychological assessment

Other

Primary outcomes

  1. Cortical gray matter (GM) volumes

    Time frame: Day 1

    using the software VBM (Voxel Based Morphometry)

  2. 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),

  3. Functional MRI activity during cognitive tests

    Time frame: Day 1

    using the software SPM (Statistical Parametric Mapping)

  4. Functional connectivity in resting-state fMRI

    Time frame: Day 1

    using the CONN toolbox (functional connectivity toolbox) of SPM (Statistical Parametric Mapping)

  5. Subcortical gray matter (GM) volumes

    Time frame: Day 1

    using the software VBM (Voxel Based Morphometry)

  6. Functional MRI activity during emotional tests

    Time frame: Day 1

    using the software SPM (Statistical Parametric Mapping)

  7. Functional connectivity in resting-state fMRI

    Time frame: Day 1

    using the graph-theory methods

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: HP

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 6, 2016
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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