Study of Gesture and Executive Functions in Children With High Intellectual Potential (MOHPI)

October 1, 2020 updated by: University Hospital, Brest
The main objective of this study is to determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Brest, France, 29200
        • University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

All participants :

  • Informed consent of the child and both parents obtained
  • Affiliated to Social Security
  • Participants must be between 6 and 16 years of age.

Child with high intellectual potential :

  • Score ≥ 130 on an intellectual efficiency scale administered by a psychologist

Control child :

  • They will have to be intellectually efficient in the standard. To ensure this, the two sub-tests of the Intellectual Efficiency Scale (WISC-V) most closely correlated with intelligence (Vocabulary and Matrices) will be administered to them. Thus, the child must meet one of the following criteria in order to be included:
  • Have two standard notes between -1 and +1 DS (between 7 and 13);
  • Have one of its two notes between -1 and + 1DS (between 7 and 13) and the other between -2DS and <+ 2DS (between 5 and 15).

Exclusion Criteria:

All participants :

  • Neurological history (epilepsy, cranial trauma, prematurity ...)
  • Psychiatric history (Autistic Spectrum Disorder ...),
  • Known genetic disease,
  • Motor deficiency (eg hemiplegia),
  • Elementary sensory disorder (auditory and visual) or insufficient command of French, limiting the understanding and participation in the study likely to impact the results to the protocol.
  • Gnosic visual or linguistic deficiency.
  • Sensory disorder
  • Psychotropic Intake

Control child :

  • High intellectual potential
  • Known or suspected learning disability (no dyslexia-dysorthography, dysphasia, dyspraxia, dyscalculia).

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High intellectual potential
Participation in the study involves the conduct of a clinical examination in neurology, the collection of anamnestic elements and a neuropsychological examination in children with high intellectual potential.
Other: clinical examination in neurology
This examination is based on the movement of the child in a standing position (forward and backward on a straight line, jumping on a foot ...), seated (visual continuation ...) and elongated (tone, patellar and achillian reflexes, superficial sensitivity ...) . This makes it possible to evaluate all the neurological systems.
Other: neuropsychological examination
This examination is based on the use of standardized psychometric tools and validated with children, usually used in clinical practice.
Other: anamnestic elements
Several elements will be collected during the clinical interview to inform the history of the child's development, such as neonatal data (term of pregnancy, APGAR score ...), age of appearance of the first words , seating, walking, possible care, level of education ans level of education of the parents.
Other: Control
Participation in the study involves the conduct of a clinical examination in neurology, the collection of anamnestic elements and a neuropsychological examination in control children with no particularities.
Other: clinical examination in neurology
This examination is based on the movement of the child in a standing position (forward and backward on a straight line, jumping on a foot ...), seated (visual continuation ...) and elongated (tone, patellar and achillian reflexes, superficial sensitivity ...) . This makes it possible to evaluate all the neurological systems.
Other: neuropsychological examination
This examination is based on the use of standardized psychometric tools and validated with children, usually used in clinical practice.
Other: anamnestic elements
Several elements will be collected during the clinical interview to inform the history of the child's development, such as neonatal data (term of pregnancy, APGAR score ...), age of appearance of the first words , seating, walking, possible care, level of education ans level of education of the parents.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neuropsychological assessment
Time Frame: 1 day
Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children with WISC-V scale (Wechsler).
1 day
Neurological assessments
Time Frame: 1 day
Dysfunction (yes/no) for children with high intellectual potential compared to control children.
1 day
Neuropsychological assessment
Time Frame: 1 day
Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With Purdue Pegboard test.
1 day
Neuropsychological assessment
Time Frame: 1 day
Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With subtest Fluence Verbale (NEPSY-II)
1 day
Neuropsychological assessment
Time Frame: 1 day
Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With subtest of motricity (NEPSY-II)
1 day
Neuropsychological assessment
Time Frame: 1 day
Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With Rey test
1 day
Neuropsychological assessment
Time Frame: 1 day
Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With writing test (BHK)
1 day
Neuropsychological assessment
Time Frame: 1 day
Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With New card sorting test
1 day
Neuropsychological assessment
Time Frame: 1 day
Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With comportemental scale (BRIEF)
1 day
Neuropsychological assessment
Time Frame: 1 day
Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With M-ABC-II questionary
1 day

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Brest

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sylviane PEUDENIER, CHRU Brest

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 22, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MOHPI (RB 16.145)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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