NCT03140475: METASENS

Explorations of the Normal Neural Behavioral and Pathological Bases of Metacognition

Completed Last updated 7 March 2025

What this trial tests

trial in Schizophrenia in 109 participants. Completed in 5 March 2025.

Timeline

27 April 2017

Primary endpoint
5 March 2025

5 March 2025

Quick facts

Lead sponsor	Versailles Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	109
Start date	27 April 2017
Primary completion	5 March 2025
Estimated completion	5 March 2025
Sites	3 locations across France

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Insight Impaired — all drugs for Insight Impaired →
• Social Skills — all drugs for Social Skills →
• Behavior — all drugs for Behavior →

Sponsor

Versailles Hospital

Who can join

Adults 18 to 65, any sex, with Schizophrenia or Insight Impaired. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Confidence in visual motion discrimination is preserved in individuals with schizophrenia.
   Faivre N, Roger M, Pereira M, de Gardelle V, et al · · 2021 · cited 17× · PMID 33009905 · DOI 10.1503/jpn.200022
2. Preserved electrophysiological markers of confidence in schizophrenia spectrum disorder.
   Rouy M, Roger M, Goueytes D, Pereira M, et al · · 2023 · cited 1× · PMID 36823178 · DOI 10.1038/s41537-023-00333-4
3. Preserved electrophysiological markers of confidence in schizophrenia spectrum disorder
   Rouy M, Roger M, Goueytes D, Pereira M, et al · · 2022 · DOI 10.1101/2022.10.19.22281249