- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03483233
Neural Bases of the Check Process (Check)
Effective exploration of the environment, check for information to improve one's own performance, are fundamental abilities of human cognition. These abilities are dependent on the process of cognitive control.
However, they are clearly impaired and uncontrollable in certain behavioral disorders such as obsessive-compulsive disorder (OCD). Compulsive checks of these patients, spontaneously associated with a feeling of intense uncertainty, suggest disturbances of evaluative and metacognitive functions. However, no biological observations have yet been able to feed these hypotheses.
The evaluation of decisions and actions involves the middle cingulate cortex (MCC) (which belongs to a cortico-subcortical network structurally and functionally altered in OCD patients). Cingulotomy has long been used as a therapy in severe OCD, with However, the precise part of the cingulate cortex that contributes to check (and its pathological forms) remains to be discovered.
The purpose of this research campaign is to determine, through functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) in healthy human subjects:
- the location and role of the MCC region involved in normal check decision processes,
- determine the identity of the entire network involved
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Bron, Frankrig
- Inserm U1208
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- adults age range 20-45 years
- being able to provide a written 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…).
- Pregnant subjects
- Subjects with neurological history
- Subjects must be willing to be advise in case of discovery of brain abnormality.
Studieplan
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: fMRI and EEG study
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fMRI and EEG study
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Measuring changes in brain activity in regions of interest when performing cognitive tasks.
Tidsramme: through study completion, an average of 3 years
|
Behavior: Measurement of reaction times of correct answer during cognitive task. fMRI and EEG: Brain activity signal, |
through study completion, an average of 3 years
|
Measuring changes in brain activity in regions of interest when performing cognitive tasks.
Tidsramme: through study completion, an average of 3 years
|
Behavior: Measurement of % of correct answer during cognitive task.
|
through study completion, an average of 3 years
|
Measuring changes in brain activity in regions of interest when performing cognitive tasks.
Tidsramme: through study completion, an average of 3 years
|
- Measurement of the amplitude of the BOLD signal change in MRI according to the different cognitive tasks in the different regions of interest. Measurement of resting GABA and Glutamate concentrations in the different regions of interest. Measurement of the amplitude of the change of the electrical signal in EEG according to the different cognitive tasks in the different regions of interest. |
through study completion, an average of 3 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Calculation of the correlations in the regions of interest of the individual values of the Blood Oxygen Level Dependent (BOLD) signal with the data of the concentration of Acide γ-aminobutyrique (GABA)
Tidsramme: through study completion, an average of 3 years
|
calculate with the bold signal (spectroscopy)
|
through study completion, an average of 3 years
|
Calculation of the correlations in the regions of interest of the individual values of the Blood Oxygen Level Dependent (BOLD) signal with the data of the amplitude of the electrical signal (EEG)
Tidsramme: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Emmanuel Procyk, Inserm U1208
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 69HCL17_0143
- 2018-A00405-50 (Anden identifikator: ID-RCB)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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