Brain Networks Involved in Inner World Control (INNERWORLD)

March 10, 2026 updated by: Hospices Civils de Lyon

Brain Networks Involved in the Cognitive Control of Inner Langage and Self Representation.

Inner speech (the "little voice" in our heads) plays a central role in our ability to perform complex cognitive tasks such as problem solving, reading, writing, thinking, and self awareness. It is estimated that at least a quarter of our lives is accompanied by inner speech, whether deliberate (mentally making a list) or more spontaneous (mind wandering). Although central to human life, its neural bases remain poorly understood. It has been recently discovered a single region in the human prefrontal cortex absent in nonhuman primates, the prefrontal operculum (PFO), which shows a pattern of functional connectivity with the rest of the brain that could give it a role in controlling inner speech. The aim of this research is to understand how the brain generates and controls inner speech using functional magnetic resonance imaging (fMRI). Dysfunctions of inner speech, especially when spontaneous and wandering, can lead to severe mental disorders (anxiety disorders, depression, verbal auditory hallucinations). It is therefore crucial to identify the role of the PFO and the networks that involve it, particularly the precuneus, in controlling inner speech across its different manifestations. The first hypothesis is that the PFO and the networks that include it play a key role in the cognitive control of inner speech in participants who experience inner speech. The second hypothesis is that the PFO is hyperactive in participants who lack inner speech (so called aphantasics), preventing the production of inner speech. To test these hypotheses, participants will complete a battery of well established questionnaires to determine whether they can produce inner speech (control participants with typical inner speech) or not (aphantasic participants). These participants will take part in an fMRI study contrasting tasks that recruit inner speech that do or do not require cognitive control. The third hypothesis is that the extent of inner speech depends on the capacity for self representation, and thus on the interaction between the PFO and the precuneus. The investigator hypothesize a positive correlation between inner speech ability and self representation capacity, associated with stronger functional connectivity between the PFO and the precuneus. The investigator predict reduced self representation in aphantasic participants. To test this, participants will complete a battery of well established questionnaires. The investigator will compute correlations between 1) behavioral performance on inner speech tasks and questionnaire scores, and 2) the network measures identified in fMRI (task activation and connectivity) and questionnaire scores.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Bron, France
        • CRNL, IMPACT team, INSERM U1028
        • Contact:
        • Principal Investigator:
          • Fadila Hadj-Bouziane
      • Bron, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Registered with the national Social Security system.
  • Right handed.
  • Native French speakers.
  • Visual acuity sufficient to read stimuli (contact lenses permitted).
  • Willing to follow MRI instructions and recommendations.
  • Able to provide written informed consent to participate in the study.

Exclusion Criteria:

  • History of known neurological or psychiatric disorder.

    • Respiratory pathologies (in particular persistent asthma) or cardiovascular diseases.
    • Speech or language disorders (aphasia, dysphasia, dysarthria, stuttering, etc.).
    • Hearing impairments.
    • Memory disorders.
    • Cognitive impairments limiting understanding of instructions.

    • Recent use of psychotropic medications. Major treatments not permitted in this research include psychotropic drugs that can alter perception, sensations, mood, consciousness, or behavior, for example:

      • Antipsychotics (valproic acid, amisulpride, aripiprazole, clozapine, cyamemazine, haloperidol, loxapine, olanzapine, risperidone).
      • Antidepressants (amitriptyline, citalopram, clomipramine, duloxetine, escitalopram, fluoxetine, mianserin, mirtazapine, nortriptyline, paroxetine, sertraline, venlafaxine).
      • Anxiolytics.
    • Pregnant or breastfeeding women. No pregnancy test will be performed at inclusion; pregnancy must be reported by self declaration.
    • Minors.
    • Persons deprived of liberty by judicial or administrative decision.
    • Persons admitted to a health or social institution for reasons other than research.
    • Adults under legal protection measures (guardianship, conservatorship).
    • Persons not affiliated with a social security scheme or with a similar scheme only.
    • Participants refusing to be informed in case of an incidental finding on MRI.

    • Contraindications to fMRI, including:

      • Pacemaker, neurosensory stimulator, or implantable defibrillator: risk of transient or permanent device damage or heating of metal parts. In patients with such devices, scanning should be performed only if absolutely necessary, with the patient's informed agreement after clear explanation of risks, and in the presence of a physician from the referring service.
      • Metallic prostheses: potential for significant artifacts depending on size and ferromagnetic properties; certain neurosurgical clips or cardiac valves may pose problems and require verification of the exact implanted model.
      • Ferromagnetic ocular or intracranial foreign bodies near nervous structures: risk of displacement and ocular or cerebral injury.
      • Cochlear implants: risk of demagnetization, electrode heating, and artifacts.
      • Neurosurgical shunt valves.
      • Claustrophobic participants.
      • Dental appliances.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Neurotypical subjects
The study population will consist of healthy adult human participants, male and female, with inner speech, whose native language is French
Behavioral: Neuropsychological evaluation, questionnaires, and training on the tasks that will be performed in the MRI.
The neuropsychological/questionnaires evaluation is a 3 hour visit during which participants will complete a battery of neuropsychological tests and respond to questionnaires assessing their capacity for inner speech and self representation. In a second 30 minute visit, they will be trained on the tasks (inner speech tasks and control tasks) that they will perform in the MRI.
Other: MRI visits
There will be two 2 hour MRI visits. During the first visit, participants will perform the learned task conditions designed to test the control of inner speech; during the second visit, they will perform the control conditions and an anatomical MRI will be acquired, as well as a resting state fMRI scan to study functional connectivity and a DTI scan to study structural connectivity
Experimental: Aphantasic subjects
The study population will consist of healthy adult human participants, male and female, without inner speech, whose native language is French
Behavioral: Neuropsychological evaluation, questionnaires, and training on the tasks that will be performed in the MRI.
The neuropsychological/questionnaires evaluation is a 3 hour visit during which participants will complete a battery of neuropsychological tests and respond to questionnaires assessing their capacity for inner speech and self representation. In a second 30 minute visit, they will be trained on the tasks (inner speech tasks and control tasks) that they will perform in the MRI.
Other: MRI visits
There will be two 2 hour MRI visits. During the first visit, participants will perform the learned task conditions designed to test the control of inner speech; during the second visit, they will perform the control conditions and an anatomical MRI will be acquired, as well as a resting state fMRI scan to study functional connectivity and a DTI scan to study structural connectivity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To assess the role of the prefrontal operculum (PFO) (and the brain network to which it belongs)
Time Frame: at 60 days
MRI measurement (without contrast injection) according to the conditions of inner speech used
at 60 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess the relation between MRI and behavioral measures - behavioral performance
Time Frame: during 60 days
MRI (task activation and functional connectivity) and diffusion tensor imaging DTI (structural connectivity) in correlation with behavioral performance on inner speech tasks. The unit of the behavioral performance is the percent correct
during 60 days
To assess the relation between MRI and behavioral measures - inner speech
Time Frame: during 60 days
MRI (task activation and functional connectivity) and diffusion tensor imaging DTI (structural connectivity) in correlation with scores on inner speech and self perception questionnaires specific to each participant (unit reflecting the participants' profile).
during 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL25_0796

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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