High Intellectual PotentialMOHPINCT03128125
Study of Gesture and Executive Functions in Children With High Intellectual Potential
A study testing clinical examination in neurology, neuropsychological examination and anamnestic elements in people with High Intellectual Potential and Children, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- High Intellectual Potential, Children
- What is being tested?
- clinical examination in neurology, neuropsychological examination and anamnestic elements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2017to 22 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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).
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- High Intellectual Potential, Children
- Being tested
- clinical examination in neurology, neuropsychological examination, anamnestic elements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical examination in neurologyOther
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 examinationOther
This examination is based on the use of standardized psychometric tools and validated with children, usually used in clinical practice.
anamnestic elementsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High intellectual potential | Experimental | 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. Receives: Other: clinical examination in neurology; Other: neuropsychological examination; Other: anamnestic elements |
| Control | Other | 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. Receives: Other: clinical examination in neurology; Other: neuropsychological examination; Other: anamnestic elements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological assessment
Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children with WISC-V scale (Wechsler).
Measured: 1 day
Neurological assessments
Dysfunction (yes/no) for children with high intellectual potential compared to control children.
Measured: 1 day
Neuropsychological assessment
Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With Purdue Pegboard test.
Measured: 1 day
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)
Measured: 1 day
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)
Measured: 1 day
Neuropsychological assessment
Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With Rey test
Measured: 1 day
Neuropsychological assessment
Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With writing test (BHK)
Measured: 1 day
Neuropsychological assessment
Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With New card sorting test
Measured: 1 day
Neuropsychological assessment
Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With comportemental scale (BRIEF)
Measured: 1 day
Neuropsychological assessment
Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With M-ABC-II questionary
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start6 Apr 2017
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Intellectual PotentialStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Case-control study, monocentric.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylviane PEUDENIER, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128125
- Sponsor's protocol ID
- MOHPI (RB 16.145)
- Acronym
- MOHPI
- Status last verified
- Oct 2020
- First submitted
- 22 Mar 2017
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Gesture and Executive Functions in Children With High Intellectual Potential
- ClinicalTrials.gov ID
- NCT03128125
- Acronym / sponsor ID
- MOHPI / MOHPI (RB 16.145)
- Conditions
- High Intellectual Potential, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case-control study, monocentric.
| Arm | Type | Receives |
|---|---|---|
| High intellectual potential | Experimental | Other: clinical examination in neurology, Other: neuropsychological examination, Other: anamnestic elementsParticipation 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. |
| Control | Other | Other: clinical examination in neurology, Other: neuropsychological examination, Other: anamnestic elementsParticipation 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. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Informed consent of the child and both parents obtained
- Affiliated to Social Security
- Participants must be between 6 and 16 years of age.
- Score ≥ 130 on an intellectual efficiency scale administered by a psychologist
- 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:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical examination in neurologyThis 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 | Control, High intellectual potential |
| neuropsychological examinationThis examination is based on the use of standardized psychometric tools and validated with children, usually used in clinical practice. | Other | Control, High intellectual potential |
| anamnestic elementsSeveral 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, High intellectual potential |
Primary outcome
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).
Neurological assessments
Time frame: 1 day
Dysfunction (yes/no) for children with high intellectual potential compared to control children.
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.
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)
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)
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
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)
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
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
Related trials for High Intellectual Potential
RecruitingObservational study
Sensory Profile of People With High Intellectual Potential (HIP)
High Intellectual Potential
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylviane PEUDENIER principal investigator
CHRU BREST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical examination in neurology, neuropsychological examination and anamnestic elements in people with High Intellectual Potential and Children, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological assessment (time frame: 1 day). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.