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

June 30, 2016 updated by: Hospices Civils de Lyon

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Service de psychiatrie infantile, Hôpital Pierre Wertheimer, 59 Boulevard Pinel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laminar HP
Structural and functional MRI markers
Other: MRI
MRI and neuropsychological assessment planned for the study for patient and volunteers
Other: neuropsychological assessment
Experimental: Complex HP
Structural and functional MRI markers
Other: MRI
MRI and neuropsychological assessment planned for the study for patient and volunteers
Other: neuropsychological assessment
Experimental: ADHD
Structural and functional MRI markers
Other: MRI
MRI and neuropsychological assessment planned for the study for patient and volunteers
Other: neuropsychological assessment
Other: Control
Structural and functional MRI markers
Other: MRI
MRI and neuropsychological assessment planned for the study for patient and volunteers
Other: neuropsychological assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortical gray matter (GM) volumes
Time Frame: Day 1
using the software VBM (Voxel Based Morphometry)
Day 1
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),
Day 1
Functional MRI activity during cognitive tests
Time Frame: Day 1
using the software SPM (Statistical Parametric Mapping)
Day 1
Functional connectivity in resting-state fMRI
Time Frame: Day 1
using the CONN toolbox (functional connectivity toolbox) of SPM (Statistical Parametric Mapping)
Day 1
Subcortical gray matter (GM) volumes
Time Frame: Day 1
using the software VBM (Voxel Based Morphometry)
Day 1
Functional MRI activity during emotional tests
Time Frame: Day 1
using the software SPM (Statistical Parametric Mapping)
Day 1
Functional connectivity in resting-state fMRI
Time Frame: Day 1
using the graph-theory methods
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Olivier REVOL, MD, HCL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

June 9, 2016

First Submitted That Met QC Criteria

June 30, 2016

First Posted (Estimate)

July 6, 2016

Study Record Updates

Last Update Posted (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

June 30, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-805

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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