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

NCT02823782 | Completed

• 1 other identifier: 2013-805
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

Laminar HP; Complex HP

Outcome Measures

Primary Outcomes (7)

• Cortical gray matter (GM) volumes

  using the software VBM (Voxel Based Morphometry)

  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),

  Day 1

• Functional MRI activity during cognitive tests

  using the software SPM (Statistical Parametric Mapping)

  Day 1

• Functional connectivity in resting-state fMRI

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

  Day 1

• Subcortical gray matter (GM) volumes

  using the software VBM (Voxel Based Morphometry)

  Day 1

• Functional MRI activity during emotional tests

  using the software SPM (Statistical Parametric Mapping)

  Day 1

• Functional connectivity in resting-state fMRI

  using the graph-theory methods

  Day 1

Study Arms (4)

Laminar HP

EXPERIMENTAL

Structural and functional MRI markers

Other: MRI; Other: neuropsychological assessment

Complex HP

EXPERIMENTAL

Structural and functional MRI markers

Other: MRI; Other: neuropsychological assessment

ADHD

EXPERIMENTAL

Structural and functional MRI markers

Other: MRI; Other: neuropsychological assessment

Control

OTHER

Structural and functional MRI markers

Other: MRI; Other: neuropsychological assessment

Interventions

MRI OTHER

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

ADHD; Complex HP; Control; Laminar HP

neuropsychological assessment OTHER

ADHD; Complex HP; Control; Laminar HP

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69500, France

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Olivier REVOL, MD

  HCL

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: July 6, 2016
• Study Start: May 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 6, 2016

Record last verified: 2016-06

Locations

FR (1)