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

NCT ID: NCT02823782

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-02-28

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Laminar HP

Structural and functional MRI markers

Group Type: EXPERIMENTAL

MRI

Intervention Type: OTHER

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

neuropsychological assessment

Intervention Type: OTHER

Complex HP

Structural and functional MRI markers

Group Type: EXPERIMENTAL

MRI

Intervention Type: OTHER

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

neuropsychological assessment

Intervention Type: OTHER

ADHD

Structural and functional MRI markers

Group Type: EXPERIMENTAL

MRI

Intervention Type: OTHER

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

neuropsychological assessment

Intervention Type: OTHER

Control

Structural and functional MRI markers

Group Type: OTHER

MRI

Intervention Type: OTHER

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

neuropsychological assessment

Intervention Type: OTHER

Interventions

MRI

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

Intervention Type: OTHER

neuropsychological assessment

Intervention Type: OTHER

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier REVOL, MD

Role: PRINCIPAL_INVESTIGATOR

HCL

Locations

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

Bron, , France

Countries

France

Other Identifiers

2013-805

Identifier Type: -

Identifier Source: org_study_id