Executive Training and Brain in Adolescent (APEX-ADO)
28. juni 2019 opdateret af: Centre Hospitalier St Anne
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Paris, Frankrig, 75014
- Centre Hospitalier Sainte-Anne
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Paris, Frankrig, 75014
- Centre de Recherche Clinique (CRC) - CHSA
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år til 17 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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);
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Active control
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25 training sessions of 15 minutes per day, 5 days a week for a month of crystallised intelligence
25 training sessions of 15 minutes per day, 5 days a week for a month of inhibitory control
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Eksperimentel: Inhibitor control
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25 training sessions of 15 minutes per day, 5 days a week for a month of crystallised intelligence
25 training sessions of 15 minutes per day, 5 days a week for a month of inhibitory control
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Brain plasticity : Longitudinal cortical thickness change
Tidsramme: Baseline
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Baseline
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Brain plasticity : Longitudinal cortical thickness change
Tidsramme: one month IC training
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one month IC training
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Catherine OPPENHEIM, Centre Hospitalier Sainte-Anne
- Studieleder: Arnaud Cachia, PhD, Pr, University Paris Descartes
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- Cachia 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.
- Borst 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
18. maj 2016
Primær færdiggørelse (Faktiske)
1. november 2017
Studieafslutning (Faktiske)
1. december 2017
Datoer for studieregistrering
Først indsendt
6. april 2016
Først indsendt, der opfyldte QC-kriterier
14. marts 2017
Først opslået (Faktiske)
21. marts 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juli 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juni 2019
Sidst verificeret
1. juni 2019
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- D15-P017
- 2015-A00811-48 (Anden identifikator: ANSM)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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