Clinical trial NCT07003529: Role of Inferior Colliculi in Auditory Hallucinations
Official title: Rôle Des Colliculi inférieurs Dans Les Hallucinations Auditives : étude Pilote Par Neuroimagerie
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia
Hallucinations, Auditory
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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
* Clinical condition compatible with imaging based on clinical judgment
* 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.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Resting state of functional connectivity of the inferior colliculi region with other regions of the auditory network between groups
timeFrame: Day 0
measure: Default mode network patterns between groups
timeFrame: Day 0
Secondary outcomes:
measure: Neuronal activation in the ICs during exposure to auditory stimuli between groups
timeFrame: Day 0
measure: Per-auditory activation in other brain areas between groups
timeFrame: Day 0
measure: IC metabolite composition between the groups
timeFrame: Day 0
measure: Structural connectivity via white matter between ICs and other auditory network structures between groups
timeFrame: Day 0
measure: Correlation between BOLD signal and psychopathological symptoms
timeFrame: Day 0
measure: Correlation between BOLD signal and severity of delusions and hallucinations
timeFrame: Day 0
measure: Correlation between BOLD signal and doses of antipsychotic treatment
timeFrame: Day 0
measure: Difference in perauditory activation and functional connectivity (resting-state) in SCZ+ HA+ patients who hallucinated during the procedure and those who did not
timeFrame: Day 0
measure: Correlation between BOLD signal and dissociation symptoms
timeFrame: Day 0
measure: Correlation between BOLD signal and severity of somatoform manifestations of dissociation
timeFrame: Day 0
measure: Correlation between BOLD signal and clinically assessed states of dissociation
timeFrame: Day 0
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU de Nîmes, Hôpital Universitaire Carémeau
Study officials:
affiliation: CHU de Nimes
name: Martin Pastre
role: PRINCIPAL_INVESTIGATOR
References: