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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04768335
Other study ID # CSRM01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 31, 2021
Est. completion date September 2024

Study information

Verified date March 2022
Source Hôpital le Vinatier
Contact Lydie SARTELET
Phone 0437915531
Email lydie.sartelet@ch-le-vinatier.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Schizophrenia is a mental illness with a variety of clinical symptoms that can be regrouped into 2 categories: positive and negative symptoms. This mental illness is also characterised by cognitive alterations in various fields, including social cognition difficulties and self / non-self-discrimination difficulties. Self and non-self-discrimination abilities have been regrouped under a function called source memory. This source memory enables a person to identify the source of an information previously encoded. In our everyday life, these processes are necessary to distinguish events generated by an external source from imagined events. It is called reality monitoring. A number of studies have evidenced reality-monitoring alterations in patients suffering from schizophrenia. More specifically, patients would present with an externalisation bias, they would assign more imagined events to an external source. The knowledge of these deficits encourages the study of the processes involved in order to better understand the alterations, particularly including auditory processes. A recent study has shown that discrimination errors concerning certain sound characteristics (e.g. frequency) were associated to reality monitoring errors. However, the links between reality-monitoring and basic auditory processes have rarely been explored. The dysfunction of the auditory "where" path, especially the possibility to discriminate between the intra and extra cephalic localisation of sounds, could lead to difficulties to discern between what is produced by one self and what is produced by another or the local environment.


Description:

The main objective of this study is to study the links between source memory deficits and externalization abilities in schizophrenic patients and healthy subjects. Also, this study will: - evaluate the impact of emotional content on the ability to externalize an auditory perception - evaluate the abilities to separate sources concerning vocal stimuli - evaluate the basic auditory processes In order to meet the objectives, the correlation between the percentage of good attributions in the reality monitoring task and the percentage of correct perceptions in/out (sound perceived as coming from inside or outside the head) will be analyzed in the externalization task in patients suffering from schizophrenia. Will also be analyzed: - the number of correct perceptions In/Out in the externalization task - the number of correct perceptions In/Out for the emotional stimuli - the detection level of difference in pitch between 2 vocal sources pour the height discrimination task - the number of correctly identified words in the speech-in-speech task The tasks : Subjects will undergo a battery of cognitive and auditory experiments in order to answer the objectives and hypothesis. The duration of the entire experiments will be 3.30 hours. - Subjects will undergo the source monitoring task (30 min): This task is divided in 2 parts: - one part that will evaluate the reality monitoring performances (LISTENING task). Subjects either have to listen to words or imagine themselves listening to words - another part evaluating internal source monitoring performances (SAY task). Subjects either have to pronounce words or imagine themselves pronouncing words. - In order to measure perception abilities, all subjects will undergo a battery of psychoacoustic tests (30 min) including the Tone Matching Task (TMT) which evaluates the capacity of discriminating static pitch. The battery is also composed of tasks measuring length, amplitude, etc… - A yes / no discrimination task will be used to measure the externalization abilities: subjects will have to discern whether a sound is perceived as coming from inside or outside the head - the ability to separate sources will be measured using 2 paradigms: - a pitch discrimination task (30 min): it will evaluate the capacity to discern sources based on voice pitch - a speech-in-speech task (30 min): target words are presented simultaneously to masks (composed of words time reversed so that have lost the semantic content). The subject has to listen and repeat the words heard.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date September 2024
Est. primary completion date September 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Subjects aged between 18 and 65 years old - written given consent For patients with schizophrenia: - that meet the DSM-5.0 schizophrenia criteria For healthy control subjects: - absence of psychiatric disroders (past and actual) diagnosed according to the DSM-5.0 - absence of prodromal psychosis as measured by a score under 6 at the Prodromal Questionnaire PQ-16 (Ising et al., 2012) - absence of auditory disorders (actual and past) (including tinnitus) - absence of medical treatment (to the exception of contraceptive pills Exclusion Criteria: - history of neurological disorders or brain injury with loss of consciousness - subjects presenting with highly developed musical abilities (frequently practicing a musical instrument) - subjects presenting with an intellectual deficiency as measured by the Raven progressive matrices - subjects under guardianship

Study Design


Intervention

Behavioral:
cognitive experiments' session
The aim of this unique session of cognitive experiments is to study the links between source memory deficits and externalization abilities in healthy control subjects. Results of this Arm 2 will be compared to those of Arm 1.

Locations

Country Name City State
France Centre Hospitalier le Vinatier Bron

Sponsors (1)

Lead Sponsor Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Performance on a Reality monitoring task and on an externalization task A computerized source memory task was designed for this study and a computerized externalization task was also designed (see description above). Rate of correct responses in both tasks is the main outcome. one day
Secondary Performance on a task measuring the impact of emotional stimuli on externalization processes computerized externalization task. Emotional nonverbal bursts are presented, the azimuth is varied in order to create the impression of the sound coming either from inside or outside the head. Subjects have to determine whether the emotional nonverbal burst was perceived as coming from inside or outside their head. The rate of correct responses (in / out) is the outcome. one day
Secondary Performance on source separating paradigms 2 computerized tasks.
- Vocal pitch discrimination task (30 min): pairs of vocal vowels are presented, subjects will have to determine if the pairs differ in pitch or not.
The rate of correct responses is the outcome.
- Speech-in-speech task (30 min): target words are presented simultaneously to masks composed of time reversed words (having lost their semantic content). Subjects have to listen and repeat the words heard.
The rate of correct words heard is the outcome.
one day
Secondary Performance on basic auditory tasks a computerized psychoacoustic battery of tests, including a Tone Matching Task (evaluating nonverbal pitch), and other psychoacoustic tasks measuring amplitude, length of sound etc… The rate of correct responses is the outcome. one day