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NCT03140475Completed

Explorations of the Normal Neural Behavioral and Pathological Bases of Metacognition

Source: ClinicalTrials.gov · Last updated 7 Mar 2025

Brief summary (registry, in English)

Metacognition is the ability to introspect and report one's own mental states, or in other words to know how much one knows. It allows us to form a sense of confidence about decisions one makes in daily life, so one can commit to one option if our confidence is high, or seek for more evidence before commitment if our confidence is low. Although this function is crucial to behave adequately in a complex environment, confidence judgments are not always optimal. Notably, individuals with schizophrenia are prone to overconfidence in errors and underconfidence in correct answers. In schizophrenia, confidence is less correlated with performance compared to controls. These aspects are held to be at the origin of delusions, disorganization, poor insight into illness and into cognitive deficit and poor social functioning. Our study aims at identifying the cognitive and neural processes involved in metacognitive deficits in schizophrenia. Participants will perform metacognitive judgments on a low-level perceptual task (visual motion discrimination). Participants will do the first-order perceptual task by clicking on the correct answer with a mouse. During the first order task completion, the investigators will record several behavioral, physiological and neural variables. Then, participants will perform the metacognitive task with a visual analog scale. The study will address four research questions: * Q1: is schizophrenia associated with a decrease in metacognitive efficiency? Is the metacognitive deficit due to under- or over-confidence? * Q2: is the metacognitive impairment reflected at a decisional level as measured by behavioral variables (mouse tracking and reaction times)? * Q3: which physiological markers (EEG, skin conductance, heart rate) are predictors of metacognitive efficiency in individuals with schizophrenia and healthy controls? * Q4: which clinical symptoms correlate with metacognitive deficits? The investigators make several hypotheses related to the previous research questions: * Q1: the investigators expect metacognitive deficits in schizophrenia, based on results from several studies using both qualitative and quantitative measures. The investigators will rule out that quantitative deficits are not confounded with impairments in type 1 performance, with a generalized cognitive deficit in schizophrenia (lower premorbid and current Intelligence Quotient (IQ), and deficits in executive functioning and particularly in planning and working memory abilities), with depression or with statistical flaws during analysis of confidence. * Q2: the investigators expect behavioral cues (mouse tracking and reaction times) to be less correlated with confidence in patients vs. controls. The investigators thus make the hypothesis that the metacognitive deficit in schizophrenia may stem from an inability to integrate pre-decisional cues while performing an explicit metacognitive judgment. * Q3: the investigators expect physiological cues (EEG with Error-Related Negativity, Lateralized Readiness Potential and alpha suppression, and arousal of the autonomic nervous system with skin conductance and heart rate ) to be less correlated with confidence in patients vs. controls. * Q4: based on previous findings, the investigators expect that several clinical dimensions of schizophrenia may correlate with metacognitive performance. The metacognitive deficit would be greater for patients with high levels of positive and disorganized symptoms, and greater for patients with low levels of clinical and cognitive insight, and low levels of social functioning.

Status (registry)
Completed
Study type
Observational
Enrollment
109 (actual)
First submitted
2 May 2017
Start date
27 Apr 2017
Primary completion date
5 Mar 2025
Lead sponsor
Versailles Hospital
NCT number
NCT03140475

What you commit to

  • Study type: Observational
  • Participants enrolled: 109
  • From 27 Apr 2017 to the primary completion date, 5 Mar 2025
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • current or prior history of untreated significant medical illness or of neurological illness
  • electroconvulsive therapy in the last three months

Other illness

  • a moderate or severe substance used disorder within the past 6 months (DSM-V criteria)

Other

  • dyschromatopsia

Who the study is looking for

  • DSM-V criteria for schizophrenia (Structured Clinical Interview for Disorders)
  • Normal or corrected-to-normal vision

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chu Grenoble
Coordinator of this site? Confirm its status
GrenobleFranceUnknown status
Centre Hospitalier de Versailles
Coordinator of this site? Confirm its status
Le ChesnayFranceUnknown status
CH Alpes-Isère
Coordinator of this site? Confirm its status
Saint-ÉgrèveFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.