- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03128125
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
This examination is based on the use of standardized psychometric tools and validated with children, usually used in clinical practice.
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.
|
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.
This examination is based on the use of standardized psychometric tools and validated with children, usually used in clinical practice.
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
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
Investigators
- 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)
April 6, 2017
Primary Completion (Actual)
August 22, 2018
Study Completion (Actual)
August 22, 2018
Study Registration Dates
First Submitted
March 22, 2017
First Submitted That Met QC Criteria
April 24, 2017
First Posted (Actual)
April 25, 2017
Study Record Updates
Last Update Posted (Actual)
October 5, 2020
Last Update Submitted That Met QC Criteria
October 1, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID 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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