- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04768335
Auditory Processes and Emotional Perception in Schizophrenia (AUDISPACE)
Pilot Study: the Links Between Basic Auditory Processes and High Functioning Cognitive Processes in Schizophrenia (Reality Monitoring and Emotional Perception)
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.
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bron, France, 69678
- Recruiting
- Centre Hospitalier le Vinatier
-
Sub-Investigator:
- Marine Mondino
-
Principal Investigator:
- Gabrielle CHESNOY
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Patient group with schizophrenia
The schizophrenic subjects will undertake a 3 hour session of cognitive experiments.
Tasks will include a battery of psychoacoustic tests, a source monitoring task, an externalization task, a pitch discrimination task and a speech-in-speech task.
|
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.
|
|
Active Comparator: Healthy control subjects
Healthy control subjects will undertake a 3 hour session of cognitive experiments.
Tasks will include a battery of psychoacoustic tests, a source monitoring task, an externalization task, a pitch discrimination task and a speech-in-speech task.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance on a Reality monitoring task and on an externalization task
Time Frame: one day
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance on a task measuring the impact of emotional stimuli on externalization processes
Time Frame: one day
|
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
|
|
Performance on source separating paradigms
Time Frame: one day
|
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
|
|
Performance on basic auditory tasks
Time Frame: one day
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSRM01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Basic Auditory Processes
-
VA Loma Linda Health Care SystemNational Institute on Deafness and Other Communication Disorders (NIDCD)TerminatedAuditory Training and Auditory Efferent SystemUnited States
-
Guangdong Raynovent Biotech Co., LtdNot yet recruiting
-
University School of Physical Education, Krakow...CompletedBasic SciencePoland
-
AmgenCompletedBasic ScienceUnited Kingdom
-
University of California, Santa BarbaraNational Eye Institute (NEI)Enrolling by invitationBasic Science: Visual Attention in Healthy Participants | Basic Science: Neural Representations of LocationUnited States
-
University of California, Santa BarbaraNational Eye Institute (NEI)Enrolling by invitationBasic Science: Visual Attention in Healthy Participants | Basic Science: Neural Representations of LocationUnited States
-
University of California, Santa BarbaraNational Eye Institute (NEI)CompletedBasic Science: Visual Attention in Healthy Participants | Basic Science: Neural Representations of LocationUnited States
-
University of California, IrvineNational Institute on Aging (NIA)RecruitingAging | Auditory Perceptual ImpairmentUnited States
-
Indiana UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Recruiting
-
Indiana UniversityNational Institute of Neurological Disorders and Stroke (NINDS)CompletedBasic ScienceUnited States
Clinical Trials on cognitive experiments' session
-
Hôpital le VinatierNot yet recruiting
-
Beijing Tongren HospitalRecruiting
-
Oslo University HospitalSouth-Eastern Norway Regional Health Authority; National Centre for Hearing...UnknownStress, Psychological | Mental Fatigue | Hearing Loss | TinnitusNorway
-
Tabriz UniversityCompleted
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingMultiple SclerosisUnited States
-
Saglik Bilimleri UniversitesiCompletedDepression | Quality of Life | Pain | Osteoarthritis, Knee | Epigenetic DisorderTurkey
-
Health and Medical University PotsdamGerman Research Foundation; Charite University, Berlin, GermanyRecruitingSubstance Use Disorders | Prevention | Affective Disorders | Self-Efficacy | Depression DisordersGermany
-
Université Catholique de LouvainRecruiting
-
Amrit SinhaNational Health Service, United KingdomUnknownTreatment as Usual | Psychological InterventionUnited Kingdom