HealthyAPEX-ADONCT03084848
Executive Training and Brain in Adolescent
A study testing Training in people with Healthy, run by Centre Hospitalier St Anne at 2 sites in France.
Trial summary
The purpose of this study is to investigate the cognitive and brain effects of inhibitory control (IC) training at adolescence. Read more about this study
- Who is it for?
- Ages 16 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 18 May 2016to Dec 2017
- 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 16 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 16-17 years old
- girl or boy ;
- French mother tongue;
- Handedness: Right;
- Schooled in a level corresponding to its age (2nd or 1st)
- Informed consent signed by the (s) holder (s) of parental authority, in agreement with the teenager
- Normal medical, neurological, neuroradiological examinations.
- Health insurance
Who cannot join
- classical exclusion criteria for MRI
- Has chronic use of alcohol or drugs;
- Abuse or substance dependence (excluding nicotine) or a toxic over 5 years or has led to comas (overdoses)
- Cognitive disorders of sudden onset that may reflect a stroke; history of head trauma with loss of consciousness for more than 1 hour, or encephalitis;
- A chronic neurological disorder, psychiatric, endocrine, hepatic and infectious disorder;
- Major disease history (diabetes, chronic lung disease, heart disorder, metabolic, hematologic, endocrine or immunological severe cancer);
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- A medication that may interfere with brain imaging measures (psychotropic drugs, hypnotics, anxiolytics, antipsychotics, anti-Parkinson, benzodiazepines, anti-inflammatory drugs, antiepileptics, antihistamines, analgesics and muscle relaxants central);
- dyschromatopsia
- Impossibility to submit itself to the study for geographical or psychiatric reasons;
- Pregnant and lactating women;
- Has pervasive developmental disorders and / or acquisitions identified by parents or legal guardian and (or) the teachers;
- Cerebral palsy;
- Fine motor disorder
- Unaccompanied by parent (s) (s) or at least a person with parental authority during the visit to the research platform;
- Tattoo on the head, neck or shoulders
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre de Recherche Clinique (CRC) - CHSA
Paris, 75014
Centre Hospitalier Sainte-Anne
Paris, 75014
About this study
Official title: Cerebral Bases of the Cognitive Learning in the Executive Control In the Adolescence
The purpose of this study is to investigate the cognitive and brain effects of inhibitory control (IC) training at adolescence.
Read the detailed description
Brain imaging now allows to study non-invasively cognitive learning processes. An area of strong scientific interest is the development of executive control, an essential cognitive domain for academic and professional success and for mental and physical health. These functions are essentially located within the prefrontal cortex, characterising by a late maturation until the end of adolescence and, while under genetic control, can likely be improved with targeted interventions. The objective of this project is simple and innovative: testing in adolescents with the most appropriate brain imaging technologies available today (the Magnetic Resonance Imaging, MRI), the effect of an executive training focused on the inhibitory control (IC). This project aims at precisely testing the effect at the cognitive and brain levels of IC training in adolescence. To do this, the investigators will recruit two groups of 30 teenagers aged 16 to 17 years old, each assigned to one of two learning situations: IC vs Active Control (AC). Each participant will participate in 25 training sessions of 15 minutes per day, 5 days a week for a month. Brain structural and functional differences in the brain and between the pre-test and post-test related to intense IC training will be correlated with cognitive progress.
- Conditions
- Healthy
- Being tested
- Training
- Keywords
- brain/cognitive measures, condition, inhibitor control, training at adolescence
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
25 training sessions of 15 minutes per day, 5 days a week for a month of crystallised intelligence
TrainingOther
25 training sessions of 15 minutes per day, 5 days a week for a month of inhibitory control
| Study group | Role | What they receive |
|---|---|---|
| Active control | Experimental | Not described Receives: Other: Training |
| Inhibitor control | Experimental | Not described Receives: Other: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain plasticity : Longitudinal cortical thickness change
Measured: Baseline
Brain plasticity : Longitudinal cortical thickness change
Measured: one month IC training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start18 May 2016
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
- Investigators
- Catherine OPPENHEIM, Principal investigator, Centre Hospitalier Sainte-AnneArnaud Cachia, PhD, Pr, Study director, University Paris Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084848
- Sponsor's protocol ID
- D15-P017
- Other IDs
- 2015-A00811-48
- Acronym
- APEX-ADO
- Status last verified
- Jun 2019
- First submitted
- 6 Apr 2016
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ahr E, Houde O, Borst G. Inhibition of the mirror generalization process in reading in school-aged children. J Exp Child Psychol. 2016 May;145:157-65. doi: 10.1016/j.jecp.2015.12.009. Epub 2016 Jan 27.
PubMed 26827098Cachia A, Borst G, Vidal J, Fischer C, Pineau A, Mangin JF, Houde O. The shape of the ACC contributes to cognitive control efficiency in preschoolers. J Cogn Neurosci. 2014 Jan;26(1):96-106. doi: 10.1162/jocn_a_00459. Epub 2013 Aug 5.
PubMed 23915057Borst G, Cachia A, Vidal J, Simon G, Fischer C, Pineau A, Poirel N, Mangin JF, Houde O. Folding of the anterior cingulate cortex partially explains inhibitory control during childhood: a longitudinal study. Dev Cogn Neurosci. 2014 Jul;9:126-35. doi: 10.1016/j.dcn.2014.02.006. Epub 2014 Feb 27.
PubMed 24642370
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Bases of the Cognitive Learning in the Executive Control In the Adolescence
- ClinicalTrials.gov ID
- NCT03084848
- Acronym / sponsor ID
- APEX-ADO / D15-P017
- Conditions
- Healthy
- Keywords
- brain/cognitive measures, condition, inhibitor control, training at adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 18 May 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Mar 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 purpose of this study is to investigate the cognitive and brain effects of inhibitory control (IC) training at adolescence.
Detailed description
Brain imaging now allows to study non-invasively cognitive learning processes. An area of strong scientific interest is the development of executive control, an essential cognitive domain for academic and professional success and for mental and physical health. These functions are essentially located within the prefrontal cortex, characterising by a late maturation until the end of adolescence and, while under genetic control, can likely be improved with targeted interventions. The objective of this project is simple and innovative: testing in adolescents with the most appropriate brain imaging technologies available today (the Magnetic Resonance Imaging, MRI), the effect of an executive training focused on the inhibitory control (IC). This project aims at precisely testing the effect at the cognitive and brain levels of IC training in adolescence. To do this, the investigators will recruit two groups of 30 teenagers aged 16 to 17 years old, each assigned to one of two learning situations: IC vs Active Control (AC). Each participant will participate in 25 training sessions of 15 minutes per day, 5 days a week for a month. Brain structural and functional differences in the brain and between the pre-test and post-test related to intense IC training will be correlated with cognitive progress.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active control | Experimental | Other: Training |
| Inhibitor control | Experimental | Other: Training |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 16-17 years old
- girl or boy ;
- French mother tongue;
- Handedness: Right;
- Schooled in a level corresponding to its age (2nd or 1st)
Key exclusion criteria (15 listed)
- classical exclusion criteria for MRI
- Has chronic use of alcohol or drugs;
- Abuse or substance dependence (excluding nicotine) or a toxic over 5 years or has led to comas (overdoses)
- Cognitive disorders of sudden onset that may reflect a stroke; history of head trauma with loss of consciousness for more than 1 hour, or encephalitis;
- A chronic neurological disorder, psychiatric, endocrine, hepatic and infectious disorder;
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 |
|---|---|---|
| Training25 training sessions of 15 minutes per day, 5 days a week for a month of crystallised intelligence | Other | Active control |
| Training25 training sessions of 15 minutes per day, 5 days a week for a month of inhibitory control | Other | Inhibitor control |
Primary outcome
Brain plasticity : Longitudinal cortical thickness change
Time frame: Baseline
Brain plasticity : Longitudinal cortical thickness change
Time frame: one month IC training
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 2 Jul 2019.
- Background: PubMed 26827098Ahr E, Houde O, Borst G. Inhibition of the mirror generalization process in reading in school-aged children. J Exp Child Psychol. 2016 May;145:157-65. doi: 10.1016/j.jecp.2015.12.009. Epub 2016 Jan 27.
- Background: PubMed 23915057Cachia A, Borst G, Vidal J, Fischer C, Pineau A, Mangin JF, Houde O. The shape of the ACC contributes to cognitive control efficiency in preschoolers. J Cogn Neurosci. 2014 Jan;26(1):96-106. doi: 10.1162/jocn_a_00459. Epub 2013 Aug 5.
- Background: PubMed 24642370Borst G, Cachia A, Vidal J, Simon G, Fischer C, Pineau A, Poirel N, Mangin JF, Houde O. Folding of the anterior cingulate cortex partially explains inhibitory control during childhood: a longitudinal study. Dev Cogn Neurosci. 2014 Jul;9:126-35. doi: 10.1016/j.dcn.2014.02.006. Epub 2014 Feb 27.
- Individual participant dataSharing planned: No
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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.
Catherine OPPENHEIM principal investigator
Centre Hospitalier Sainte-Anne
Arnaud Cachia, PhD, Pr study director
University Paris Descartes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Healthy, run by Centre Hospitalier St Anne at 2 sites 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 8 inclusion and 15 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 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Brain plasticity : Longitudinal cortical thickness change (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03084848, which also lists 3 linked publications.
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 2 Jul 2019.