SchizophreniaSchizoHICNCT07003529
Role of Inferior Colliculi in Auditory Hallucinations
A study testing Unenhanced brain MRI in people with Schizophrenia and Hallucinations, Auditory, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The neural basis of auditory hallucinations (AH) in patients with schizophrenia is poorly characterized. Functional imaging studies investigate either the "state" dimension (i.e., the measurement of changes in brain area activation at the precise moment of AH onset) or the "trait" dimension (i.e., the neural… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Hallucinations, Auditory
- What is being tested?
- Unenhanced brain MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2025to Sep 2026
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- DSM-5 diagnosis of schizophrenic disorder (based on clinical assessment and confirmed by the MINI 7.0 interview)
- Patient with a schizophrenic disorder lasting ≤ 20 years
- Patient treated in a psychiatric unit as an inpatient (in non-specialized care) or outpatient or under a mandatory ambulatory psychiatric care programme
- Clinical condition compatible with imaging based on clinical judgment
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- Ability to understand, write, and read French
- Specific inclusion criteria for the group (SCZ+/HA+) • Patient with a PANSS score (question P3 regarding hallucinations) ≥ 4 (corresponds to PANSS (P3) 4, 5, 6, and 7 patients) AND having experienced hallucinations in the past 15 days.
- Specific inclusion criteria for the control group
- Patient with a PANSS score (question P3 regarding hallucinations) = 1) AND having not experienced any hallucinations in the past 15 days.
Who cannot join
- The patient is under safeguard of justice or state guardianship
- Contraindications to magnetic resonance imaging, including severe claustrophobia, based on clinical judgment.
- Congenital or acquired deafness
- Suicide risk, based on clinical judgment
- Patient with moderate to severe intellectual disability, based on medical records
- Patient with moderate to severe neurocognitive disorders, based on medical records
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- Patient receiving anticholinergic therapy (biperiden-Akineton, trihexyphenidyl-Artane, tropatepine-Lepticur)
- Patient participating in an interventional study involving a drug or medical device, or a Category 1 RIPH within 3 months prior to inclusion
- Person under judicial protection
- Pregnant, parturient, or breastfeeding woman
- Person unable to express consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nîmes, Hôpital Universitaire Carémeau
Nîmes, 30029
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Ismaël Conejero
About this study
Official title: Rôle Des Colliculi inférieurs Dans Les Hallucinations Auditives : étude Pilote Par Neuroimagerie
The neural basis of auditory hallucinations (AH) in patients with schizophrenia is poorly characterized. Functional imaging studies investigate either the "state" dimension (i.e., the measurement of changes in brain area activation at the precise moment of AH onset) or the "trait" dimension (i.e., the neural correlates of the propensity to hallucinate). A corollary of AH (particularly acoustic-verbal) is the activation of brain regions involved in the auditory perception of speech (auditory cortex). One theory is that patients with schizophrenia with AH may have a deficit in processing their internal speech (i.e., external attribution to internal verbal content). However, there is little clinical data on the specific role of the mesencephalic region of the inferior colliculi (IC) in the formation of these symptoms. Preliminary research has shown intense expression of dopamine D2 receptors, particularly on glutamatergic neurons in mouse ICs. Thus, ICs receive numerous inhibitory dopaminergic inputs, likely involved in signal optimization and modulation. The study authors hypothesize that AHs are the result of a defect in signal inhibition by the IC, which lose their function as perceptual filters.
- Conditions
- Schizophrenia, Hallucinations, Auditory
- Being tested
- Unenhanced brain MRI
- Medical subject headings
- Schizophrenia, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unenhanced brain MRIOther
Unenhanced brain MRI in five sequences: 1) T1-weighted anatomical sequences 2) Resting-state functional sequences 3) Task-based functional sequence 4) Structural sequence using Diffusion Tensor Imaging (DTI) 5) Routine magnetic resonance spectroscopy sequence
| Study group | Role | What they receive |
|---|---|---|
| Patient Group (SCZ+/AH+) | Experimental | schizophrenic patients experiencing auditory hallucinations Receives: Other: Unenhanced brain MRI |
| Control Group (SCZ+/AH-) | Experimental | schizophrenic patients without hallucinations Receives: Other: Unenhanced brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting state of functional connectivity of the inferior colliculi region with other regions of the auditory network between groups
Measured by MRI
Measured: Day 0
Default mode network patterns between groups
Measured by MRI
Measured: Day 0
Secondary outcomes (11)
Neuronal activation in the ICs during exposure to auditory stimuli between groups
Difference in the blood-oxygen level dependent (BOLD) signal measured by functional MRI during an auditory stimulus exposure paradigm in the IC region
Measured: Day 0
Per-auditory activation in other brain areas between groups
Difference in the BOLD signal measured by functional MRI in other brain areas
Measured: Day 0
IC metabolite composition between the groups
Difference in the peak magnetic resonance spectrometry (sMRI) signal
Measured: Day 0
Structural connectivity via white matter between ICs and other auditory network structures between groups
Difference in structural connectivity using DTI (diffusion tensor imaging, anisotropy fraction calculation, mean diffusivity, and tractography) from the ICs
Measured: Day 0
Correlation between BOLD signal and psychopathological symptoms
Measured by Positive and Negative Syndrome Scale (PANSS), providing a negative symptomatology score ranging from 7 to 49, and a general psychopathology score ranging from 16 to 112, with a total score ranging from 30 to 210.
Measured: Day 0
Correlation between BOLD signal and severity of delusions and hallucinations
Measured by Psychotic Symptom Rating Scale (PSYRATS), an 11-item scale where each symptom is rated from 0 to 4 depending on the intensity
Measured: Day 0
Correlation between BOLD signal and doses of antipsychotic treatment
Antipsychotic doses calculated by olanzapine equivalent method
Measured: Day 0
Difference in perauditory activation and functional connectivity (resting-state) in SCZ+ HA+ patients who hallucinated during the procedure and those who did not
Measured via post-hoc task-based, BOLD signal state hallucination analysis
Measured: Day 0
Correlation between BOLD signal and dissociation symptoms
Measured by Dissociative Experience Scale (DES)
Measured: Day 0
Correlation between BOLD signal and severity of somatoform manifestations of dissociation
Measured by Somatoform Dissociation Questionnaire (SDQ)
Measured: Day 0
Correlation between BOLD signal and clinically assessed states of dissociation
Measured by Clinician Administered Dissociative States Scale (CADSS), a 5-point Likert scale
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start12 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Pastre, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003529
- Sponsor's protocol ID
- NIMAO2024-2/MP-01
- Acronym
- SchizoHIC
- Status last verified
- Aug 2025
- First submitted
- 20 May 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rôle Des Colliculi inférieurs Dans Les Hallucinations Auditives : étude Pilote Par Neuroimagerie
- ClinicalTrials.gov ID
- NCT07003529
- Acronym / sponsor ID
- SchizoHIC / NIMAO2024-2/MP-01
- Conditions
- Schizophrenia, Hallucinations, Auditory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 4 Jun 2025 (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.
The neural basis of auditory hallucinations (AH) in patients with schizophrenia is poorly characterized. Functional imaging studies investigate either the "state" dimension (i.e., the measurement of changes in brain area activation at the precise moment of AH onset) or the "trait" dimension (i.e., the neural correlates of the propensity to hallucinate). A corollary of AH (particularly acoustic-verbal) is the activation of brain regions involved in the auditory perception of speech (auditory cortex). One theory is that patients with schizophrenia with AH may have a deficit in processing their internal speech (i.e., external attribution to internal verbal content). However, there is little clinical data on the specific role of the mesencephalic region of the inferior colliculi (IC) in the formation of these symptoms. Preliminary research has shown intense expression of dopamine D2 receptors, particularly on glutamatergic neurons in mouse ICs. Thus, ICs receive numerous inhibitory dopaminergic inputs, likely involved in signal optimization and modulation. The study authors hypothesize that AHs are the result of a defect in signal inhibition by the IC, which lose their function as perceptual filters.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Group (SCZ+/AH+) | Experimental | Other: Unenhanced brain MRIschizophrenic patients experiencing auditory hallucinations |
| Control Group (SCZ+/AH-) | Experimental | Other: Unenhanced brain MRIschizophrenic patients without hallucinations |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- DSM-5 diagnosis of schizophrenic disorder (based on clinical assessment and confirmed by the MINI 7.0 interview)
- Patient with a schizophrenic disorder lasting ≤ 20 years
- Patient treated in a psychiatric unit as an inpatient (in non-specialized care) or outpatient or under a mandatory ambulatory psychiatric care programme
Key exclusion criteria (11 listed)
- The patient is under safeguard of justice or state guardianship
- Contraindications to magnetic resonance imaging, including severe claustrophobia, based on clinical judgment.
- Congenital or acquired deafness
- Suicide risk, based on clinical judgment
- Patient with moderate to severe intellectual disability, based on medical records
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 |
|---|---|---|
| Unenhanced brain MRIUnenhanced brain MRI in five sequences: 1) T1-weighted anatomical sequences 2) Resting-state functional sequences 3) Task-based functional sequence 4) Structural sequence using Diffusion Tensor Imaging (DTI) 5) Routine magnetic resonance spectroscopy sequence | Other | Control Group (SCZ+/AH-), Patient Group (SCZ+/AH+) |
Primary outcome
Resting state of functional connectivity of the inferior colliculi region with other regions of the auditory network between groups
Time frame: Day 0
Measured by MRI
Default mode network patterns between groups
Time frame: Day 0
Measured by MRI
11 secondary outcomes
Neuronal activation in the ICs during exposure to auditory stimuli between groups
Time frame: Day 0
Per-auditory activation in other brain areas between groups
Time frame: Day 0
IC metabolite composition between the groups
Time frame: Day 0
Structural connectivity via white matter between ICs and other auditory network structures between groups
Time frame: Day 0
Correlation between BOLD signal and psychopathological symptoms
Time frame: Day 0
Correlation between BOLD signal and severity of delusions and hallucinations
Time frame: Day 0
Correlation between BOLD signal and doses of antipsychotic treatment
Time frame: Day 0
Difference in perauditory activation and functional connectivity (resting-state) in SCZ+ HA+ patients who hallucinated during the procedure and those who did not
Time frame: Day 0
Correlation between BOLD signal and dissociation symptoms
Time frame: Day 0
Correlation between BOLD signal and severity of somatoform manifestations of dissociation
Time frame: Day 0
Correlation between BOLD signal and clinically assessed states of dissociation
Time frame: Day 0
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 9 Dec 2025.
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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.
Martin Pastre principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unenhanced brain MRI in people with Schizophrenia and Hallucinations, Auditory, run by Centre Hospitalier Universitaire de Nīmes at 1 site 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 10 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Martin Pastre (06 95 55 68 80, matinpastre@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting state of functional connectivity of the inferior colliculi region with other regions of the auditory network between groups (time frame: Day 0). The study lists 2 primary outcomes in all. 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 9 Dec 2025.