Clinical trial NCT02887794: Basic Auditory Processing and Auditory Hallucinations
Official title: Basic Auditory Processing and Acoustico-verbal Hallucinations: a Pathophysiological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: pitch discrimination
auditory processing disorders
auditory perception
auditory-verbal hallucinations
theory of mind
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Schizophrenia is a severe psychiatric disorder that affects approximately 1% of the population worldwide. Although pathophysiology of this disease remains unclear, a growing interest is emerging for low-level sensory function, acknowledging that deficits in early stages of sensory processing are related to higher-order cognitive disturbances in schizophrenia. In the field of auditory processing, symptoms as auditory-hallucinations were found correlated with disabilities to discriminate psychoacoustic parameters of sounds.

Detailed description: Outcomes: Our main hypothesis is that Auditory Hallucinations Rating Scale (AHRS) scores are correlated with the percentage of wrong answers in a Tone-Matching Task test. The main objective is to assess this correlation. Our other objectives are to assess correlation between AHRS as well as other symptoms scales and psychoacoustic tests assessing intensity, length discrimination of non-verbal tones and self-monitoring abilities. Impact of therapeutic procedures (neuromodulation, psychotherapy) conducted independently of our study on these psychoacoustic tests will also be assessed.

Methods: 30 subjects with schizophrenia will be included. Clinical and psychoacoustic measures will be carried out at J-0. In the case of patients receiving therapeutic procedures independently of our study, new clinical and psychoacoustic measures will be carried out at J+7 and J+30.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years old
* Meeting DSM-5.0 criteria for schizophrenia
* Auditory Hallucinations Rating Scale ≥ 8
* Negative βHCG level if woman
* Effective contraception if woman
* Consent to be included in the study

Exclusion Criteria:

* Hearing impairment
* Neurologic disorder
* Other psychiatric disorder from the DSM-5.0 section II
* Developed musical abilities (regular practice of singing or a musical instrument)
* Pregnancy
* Does not consent to be included in the study
* Lacking in legal capacity

Primary outcomes:
measure: percentage error in discrimination test psychoacoustic Tone Matching Task
timeFrame: immediately after treatment
Secondary outcomes:
measure: Score the item hallucinations of psychometric ( positive and negative syndrome ) scale
timeFrame: immediately after treatment
Other outcomes:
Locations:
city: Lyon
country: France
facility: Ch Le Vinatier
state: Rhone Alpes
Study officials:
affiliation: CH LE VINATIER
name: Haesebaert Frédéric, PH
role: PRINCIPAL_INVESTIGATOR
References: