- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03119870
Organization of the Cingulate Cortex (EEG-Feedback)
6. juli 2017 opdateret af: Hospices Civils de Lyon
Structure-function Relationships Within the Cingulate Cortex
Efficient evaluation and monitoring of actions and outcomes are a key feature of primates' efficient adaptive cognition.
Deficits in evaluating one's own actions and their consequences is a key feature of prominent disorders such as obsessive compulsive disorders (OCD), schizophrenia, and anxiety.
The Investigators know that these evaluative processes implicate medial structures of the brain that are related both to old limbic functions and to more recently evolved higher executive functions.
Brain potentials related to performance monitoring have attracted a lot of interest in cognitive neuroscience but also in the clinical domain because they appear to be altered in different neurological or psychiatric disorders, such as schizophrenia, OCD, or anxiety, and could become biomarkers of pathologies.
But the neural sources of these markers are not fully determined and are currently highly debated.
In addition, our work suggests that non pathological factors, such as normal morphological cortical variations, could affect those markers.
Understanding performance monitoring, acting directly on medial cortex, or using electrophysiological markers in clinic are thus currently problematic and challenging.
This is mostly because structure-function relationships in the medial wall are ill defined for historical, conceptual, and methodological reasons.
Importantly, although individual variability of brain morphology impedes precise assessment of structure function relationships, this variability is almost never taken into account.
EEG-Feedback aims to resolve these issues by evaluating the consequences of individual variability in cingulate cortex morphology on 1) surface EEG markers of feedback monitoring and 2) functional connectivity patterns thanks to resting-state fMRI.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
31
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Bron, Frankrig, 69677
- Hospices Civils de Lyon, Groupement Hospitalier Est
-
-
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
18 år til 40 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- being able to provide a writen consent form
- having a social insurance
- have a normal vision (with or without corrections)
- Right-handed
Exclusion Criteria:
- Subjects with MRI contraindications (e.g. pacemaker, claustrophobia, metal in the body, etc…).
- Subjects must be willing to be advise in case of discovery of brain abnormality.
- No history of known neurological or psychiatric illness
- Pregnant or nursing women
- Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights or liberty, as well as legal persons protected by law
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
Each subject will conduct 3 sessions, i.e. a training session, an anatomical MRI session and an EEG session.
The first session will be to train the subject to carry out the different behavioral tasks that he will then have to perform during the session of EEG.
|
Each subject will be trained to perform a trial-error learning task.
In this task, three visual stimuli will be presented to the subject.
The subject will have to find by trial-error, the one associated with positive feedback, the other stimuli being associated with negative feedback (search period).
Once the stimulus is associated with positive feedback, the subject will perform a period of repetition during which he will choose the stimulus associated with positive feedback.
Two variants of the task will be used: a variant in which feedback will be visual (ie positive feedback = green square, negative feedback = red square) and a variant in which feedback will be fruit juice (ie positive feedback = Fruit juice (but less than 2ml), negative feedback = no volume or small volume of fruit juice).
Once the tasks are learned, each subject will participate in an MRI session during which an anatomical scan will be obtained.
For each task, the time of presentation of the stimuli will be 2s.
During this time, the subject should indicate his choice of stimulus.
After a delay of 2s, feedback will be presented for 1s.
Each test shall be separated by an inter-test delay of 3s.
The presentation of the stimuli and the control of the answers will be managed by the E-prime or Presentation software.
Once the tasks are learned, each subject will participate in an MRI session during which an anatomical scan will be obtained and then an EEG session during which he will perform the task learned.For each task, the time of presentation of the stimuli will be 2s.
During this time, the subject should indicate his choice of stimulus.
After a delay of 2s, feedback will be presented for 1s.
Each test shall be separated by an inter-test delay of 3s.
The presentation of the stimuli and the control of the answers will be managed by the E-prime or Presentation software.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Resting state fMRI data
Tidsramme: 3 years
|
BOLD signal will be analyzed in the low frequency band (0.1-0.01Hz).
Images must be not too much distorted to allow data analysis.
As such, if a subject moved too much (translation>10mm; rotation>5°) the corresponding data will be excluded from the analysis.
|
3 years
|
|
EEG data
Tidsramme: 3 years
|
If recordings are too noisy (if only <30% of trials survive the denoising process), subject will be excluded from final analysis.
|
3 years
|
|
Behavioral data in the EEG experiment
Tidsramme: 3 years
|
Performance in the task will be assessed.
If performance in the task is <80%, subjects will be excluded in the final analysis.
|
3 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Christian SCHEIBER, MD, Hospices Civils de Lyon
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)
9. januar 2013
Primær færdiggørelse (Faktiske)
6. september 2013
Studieafslutning (Faktiske)
4. juli 2017
Datoer for studieregistrering
Først indsendt
9. marts 2017
Først indsendt, der opfyldte QC-kriterier
13. april 2017
Først opslået (Faktiske)
19. april 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. juli 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. juli 2017
Sidst verificeret
1. juli 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 69HCL16_0659
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Train
-
Oregon Health and Science UniversityAfsluttet
-
The Miriam HospitalBrown UniversityUkendtTræthed | KræftoverlevelseForenede Stater
-
National Cheng-Kung University HospitalAfsluttet
-
Air Force Military Medical University, ChinaAfsluttetPostoperative komplikationerKina
-
Children's Hospital of PhiladelphiaNational Institute of Mental Health (NIMH); University of PennsylvaniaAfsluttetAngstlidelserForenede Stater
-
Singapore General HospitalUkendt
-
Inonu UniversityAfsluttetLevertransplantation | Sarkopeni | Sarkopeni ved levercirrhoseTyrkiet (Türkiye)