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

ADHD Clinical Trial

— HP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823782
• Other study ID #: 2013-805
• Status: Completed
• Phase: N/A
• First received: June 9, 2016
• Last updated: June 30, 2016
• Start date: May 2013
• Est. completion date: February 2015

Study information

• Verified date: June 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Other:
• MRI
MRI and neuropsychological assessment planned for the study for patient and volunteers
• neuropsychological assessment

Locations

Country	Name	City	State
France	Service de psychiatrie infantile, Hôpital Pierre Wertheimer, 59 Boulevard Pinel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortical gray matter (GM) volumes	using the software VBM (Voxel Based Morphometry)	Day 1	No
Primary	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	No
Primary	Functional MRI activity during cognitive tests	using the software SPM (Statistical Parametric Mapping)	Day 1	No
Primary	Functional connectivity in resting-state fMRI	using the CONN toolbox (functional connectivity toolbox) of SPM (Statistical Parametric Mapping)	Day 1	No
Primary	Subcortical gray matter (GM) volumes	using the software VBM (Voxel Based Morphometry)	Day 1	No
Primary	Functional MRI activity during emotional tests	using the software SPM (Statistical Parametric Mapping)	Day 1	No
Primary	Functional connectivity in resting-state fMRI	using the graph-theory methods	Day 1	No