NeurosciencesINNERWORLDNCT07469631
Brain Networks Involved in Inner World Control
A study testing Neuropsychological evaluation, questionnaires, and training on the tasks that will be performed in the MRI. and MRI visits in people with Neurosciences, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurosciences
- What is being tested?
- Neuropsychological evaluation, questionnaires, and training on the tasks that will be performed in the MRI. and MRI visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 1 May 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
CRNL, IMPACT team, INSERM U1028
Bron
Fadila Hadj-Bouziane, 04 72 91 34 04, fadila.hadj-bouziane@inserm.fr
Fadila Hadj-Bouziane
Plateforme PRIMAGE, Cermep
Bron
Fadila Hadj-Bouziane, 04 72 91 34 04, fadila.hadj-bouziane@inserm.fr
About this study
Official title: 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.
- Conditions
- Neurosciences
- Being tested
- Neuropsychological evaluation, questionnaires, and training on the tasks that will be performed in the MRI., MRI visits
- Keywords
- Prefrontal operculum, precuneus, inner language, self, imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological evaluation, questionnaires, and training on the tasks that will be performed in the MRI.Behavioural
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.
MRI visitsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Neurotypical subjects | Experimental | The study population will consist of healthy adult human participants, male and female, with inner speech, whose native language is French Receives: Behavioral: Neuropsychological evaluation, questionnaires, and training on the tasks that will be performed in the MRI.; Other: MRI visits |
| Aphantasic subjects | Experimental | The study population will consist of healthy adult human participants, male and female, without inner speech, whose native language is French Receives: Behavioral: Neuropsychological evaluation, questionnaires, and training on the tasks that will be performed in the MRI.; Other: MRI visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the role of the prefrontal operculum (PFO) (and the brain network to which it belongs)
MRI measurement (without contrast injection) according to the conditions of inner speech used
Measured: at 60 days
Secondary outcomes (2)
To assess the relation between MRI and behavioral measures - behavioral performance
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
Measured: during 60 days
To assess the relation between MRI and behavioral measures - inner speech
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).
Measured: during 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurosciencesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469631
- Sponsor's protocol ID
- 69HCL25_0796
- Acronym
- INNERWORLD
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Networks Involved in the Cognitive Control of Inner Langage and Self Representation.
- ClinicalTrials.gov ID
- NCT07469631
- Acronym / sponsor ID
- INNERWORLD / 69HCL25_0796
- Conditions
- Neurosciences
- Keywords
- Prefrontal operculum, precuneus, inner language, self, imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurotypical subjects | Experimental | Behavioral: Neuropsychological evaluation, questionnaires, and training on the tasks that will be performed in the MRI., Other: MRI visitsThe study population will consist of healthy adult human participants, male and female, with inner speech, whose native language is French |
| Aphantasic subjects | Experimental | Behavioral: Neuropsychological evaluation, questionnaires, and training on the tasks that will be performed in the MRI., Other: MRI visitsThe study population will consist of healthy adult human participants, male and female, without inner speech, whose native language is French |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (25 listed)
- History of known neurological or psychiatric disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Aphantasic subjects, Neurotypical subjects |
| MRI visitsThere 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 | Other | Aphantasic subjects, Neurotypical subjects |
Primary outcome
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
2 secondary outcomes
To assess the relation between MRI and behavioral measures - behavioral performance
Time frame: during 60 days
To assess the relation between MRI and behavioral measures - inner speech
Time frame: during 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological evaluation, questionnaires, and training on the tasks that will be performed in the MRI. and MRI visits in people with Neurosciences, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fadila Hadj-Bouziane (04 72 91 34 04, fadila.hadj-bouziane@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the role of the prefrontal operculum (PFO) (and the brain network to which it belongs) (time frame: at 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.