- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07469631
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
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- 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
- Name: Fadila Hadj-Bouziane
- Phone Number: 04 72 91 34 04
- Email: fadila.hadj-bouziane@inserm.fr
Study Locations
-
-
-
Bron, France
- CRNL, IMPACT team, INSERM U1028
-
Contact:
- Fadila Hadj-Bouziane
- Phone Number: 04 72 91 34 04
- Email: fadila.hadj-bouziane@inserm.fr
-
Principal Investigator:
- Fadila Hadj-Bouziane
-
Bron, France
- Plateforme PRIMAGE, Cermep
-
Contact:
- Fadila Hadj-Bouziane
- Phone Number: 04 72 91 34 04
- Email: fadila.hadj-bouziane@inserm.fr
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Neurotypical subjects
The study population will consist of healthy adult human participants, male and female, with inner speech, whose native language is French
|
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.
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
|
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.
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
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
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
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)
May 1, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Study Registration Dates
First Submitted
February 24, 2026
First Submitted That Met QC Criteria
March 10, 2026
First Posted (Actual)
March 13, 2026
Study Record Updates
Last Update Posted (Actual)
March 13, 2026
Last Update Submitted That Met QC Criteria
March 10, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Neurosciences
-
National Taiwan University HospitalCompleted
-
Massachusetts General HospitalBrown UniversityRecruiting
-
National Taiwan University HospitalCompletedExecutive Function | NeurosciencesTaiwan
-
Université Catholique de LouvainRecruitingVisual NeurosciencesBelgium
-
Michael J. Wesley, PhDNational Institute on Drug Abuse (NIDA)CompletedSubstance-Related Disorders | Behavior Problem | NeurosciencesUnited States
-
Centre Hospitalier St AnneRecruitingMental Disorders | MRI | Stroke | Brain Tumor | NeurosciencesFrance
Clinical Trials on Neuropsychological evaluation, questionnaires, and training on the tasks that will be performed in the MRI.
-
Ege UniversityRecruitingBreastfeeding, Exclusive | GrandmotherTurkey
-
Hospital for Special Surgery, New YorkCompletedFractures, Bone | Deformity; BoneUnited States
-
Suleyman Demirel UniversityNot yet recruitingLumbar Surgery | Lumbar DiseaseTurkey (Türkiye)
-
Centre Hospitalier Universitaire de NiceCompletedChronic Kidney DiseaseFrance
-
Memorial Sloan Kettering Cancer CenterJoan Karnell Cancer Center at PennsylvaniaCompletedBreast Cancer | Lung Cancer | Prostate Cancer | Gynecological Cancers | Lymphoma CancerUnited States
-
Central Hospital, Nancy, FranceRecruiting
-
Memorial Sloan Kettering Cancer CenterCompletedGastric Cancer | Pancreatic CancerUnited States
-
King Saud UniversityRecruitingCervical Degenerative DiseaseSaudi Arabia
-
Memorial Sloan Kettering Cancer CenterAckerman Institute for FamilyActive, not recruitingSupport of the Family as a Caregiving SystemUnited States
-
Memorial Sloan Kettering Cancer CenterNational Institutes of Health (NIH)Completed