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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03128125
Other study ID # MOHPI (RB 16.145)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 6, 2017
Est. completion date August 22, 2018

Study information

Verified date October 2020
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date August 22, 2018
Est. primary completion date August 22, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
neuropsychological examination
This examination is based on the use of standardized psychometric tools and validated with children, usually used in clinical practice.
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.

Locations

Country Name City State
France University Hospital Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neuropsychological assessment Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children with WISC-V scale (Wechsler). 1 day
Primary Neurological assessments Dysfunction (yes/no) for children with high intellectual potential compared to control children. 1 day
Primary Neuropsychological assessment Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With Purdue Pegboard test. 1 day
Primary Neuropsychological assessment 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
Primary Neuropsychological assessment 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
Primary Neuropsychological assessment Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With Rey test 1 day
Primary Neuropsychological assessment Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With writing test (BHK) 1 day
Primary Neuropsychological assessment Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With New card sorting test 1 day
Primary Neuropsychological assessment Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With comportemental scale (BRIEF) 1 day
Primary Neuropsychological assessment Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With M-ABC-II questionary 1 day
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