SchizophreniaNCT02588014
The Neural Bases of Early Visual and Auditory Processing and Emotion Recognition Deficits in Schizophrenia
An observational study of Schizophrenia and Healthy, run by Shalvata Mental Health Center.
Trial summary
The purpose of this project is to examine potential mechanisms that may underlie early visual and auditory perception as well as visual and auditory affect perception deficits in schizophrenia and the possible connection between these processes. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Healthy
- What is being tested?
- Magnetoencephalography
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals diagnosed with schizophrenia
Who may be able to join
- Capable and willing to provide informed consent
- Diagnosis of schizophrenia or schizoaffective
- Right handedness
- Corrected visual acuity
- No color blindness
- Normal hearing
Show all 13Show fewer
- IQ ≥ 70
- Capable and willing to provide informed consent
- Right handedness
- Corrected visual acuity
- No color blindness
- Normal hearing
- IQ ≥ 70
Who cannot join
- Left handedness
- Intellectual Disability
- Impaired vision
- Impaired hearing
- Colour blindness
- History of significant head injury or neurological illness
Show all 17Show fewer
- Current diagnosis of substance dependence
- Metallic implants
- Severe current mental instability that precludes participation in the MEG task
- Psychiatric history
- Intellectual Disability
- Impaired vision
- Impaired hearing
- Colour blindness
- History of significant head injury or neurological illness
- Current diagnosis of substance dependence
- Metallic implants
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Examining the Neural Bases of Early Visual and Auditory Processing and Emotion Recognition Deficits in Schizophrenia Using Magnetoencephalography
The purpose of this project is to examine potential mechanisms that may underlie early visual and auditory perception as well as visual and auditory affect perception deficits in schizophrenia and the possible connection between these processes. Given that affect perception largely involves visual and/or auditory information processing and likely relies on intact basic visual and/or auditory perceptual mechanisms, the investigators will examine affect perception deficits within the framework of the more basic visual and auditory processes. Specifically, the investigators will examine magnetophysiological correlates of vocal and visual affect discrimination, non-affective face discrimination and voice discrimination, and simple visual and auditory stimulus discrimination, using Magnetoencephalography (MEG), to identify neural mechanisms underlying perceptual deficits, as well as their contribution to affect perception deficits in schizophrenia.
Read the detailed description
Patients will be recruited from Shalvata mental health center and evaluated clinically in Shalvata mental health center. The MEG scan will take place at Bar-Ilan University at the Brain Research Center. Participants will get to and from the university with one of the researchers. Patients from the closed ward will be taken from Shalvata mental health center after receiving a signed letter from a relevant staff member allowing them to leave the hospital for the purpose of the research. At the end of the experiment hospitalized patients will be returned to the hospital and non-hospitalized ones to their preferred destination.
First stage (to take place in Shalvata): After the informed consent process a clinical evaluation will be performed. The evaluation will be administered to all participants and will include: demographic details and psychiatric history questionnaire, social functioning scale, handedness questionnaire, four-factor index of social statues for socioeconomic evaluation, Ischihara Color Blindness Test, Snellen wall chart for visual evaluation, TONI-3 test for intelligence evaluation, Hebrew version of the Manchester Short Assessment of Quality of Life, Interpersonal Reaction Index for empathy evaluation, and SCID for DSM-IV. In addition, the PANSS questionnaire will be administered to schizophrenic and schizoaffective patients. Time estimation: 1-2 hours.
Second stage (to take place at Bar-Ilan University and if necessary to be divided into two separate visits): Conducting a brain scan during a battery of tasks that will test neural mechanisms underlying visual and auditory perceptual deficits, as well as their contribution to affect perception deficits in schizophrenia at different levels of the visual and auditory processing. This stage will begin with a preparation for the scan (10-20 minutes) and then the following tasks will take place: Task 1. Gratings Perception task in which participants have to detect the 5% vertical gratings. The aim of this task is to identify the neural mechanisms underlying basic visual perceptual deficits in individuals with schizophrenia by probing the M- and P-pathways using HSF and LSF in a neutral, semantically meaningless, stimuli (~3 minutes); Task 2. Basic Color Processing Task - participants will have to detect 5% of white backgrounds among 180 red, green and gray backgrounds. The aim of this task is to asses neural mechanisms underlying basic visual perception by probing the M- and P pathways using basic color stimuli (~3minutes); Task 3. Orientation Detection Task - a task designed to identify another level of visual processing complexity, in which participants are asked to detect a missing gap in a square, displaying on green, red or gray background (~2 minutes); Task 4. Oddball Task in which participants have to detect infrequent sounds and ignore frequent and novel sounds. The aim of this task is to identify the basic neural mechanisms underlying auditory perception in individuals with schizophrenia (~13 minutes); Task 5. High and low spatial frequency facial expressions perception task. In this task participants have to identify the facial expression of the target stimuli out of three possible expressions: neutral facial expression, happy facial expression and afraid facial expression. The aim of this task is to identify the neural mechanisms underlying neutral facial perception deficit as well as affect perception deficit in individuals with schizophrenia by probing the M- and P-pathways using HSF and LSF facial stimuli (~25 minutes including breaks). Task 6. Colored Face Recognition task - Face stimuli are the same as the broad band stimuli from the previous task with one difference: faces are colored and surrounded by red, green or gray colored backgrounds. Procedure is the same as in the previous task (~25 minutes including breaks); Task 7. Processing of Affective Human Voices task in which participants have to detect and identify the content of human sounds (~15 minutes). Time estimation of the second stage of the experiment is about two hours including breaks. Total time estimation of both experimental stages: Four hours.
At the end of the experiment participants will be thanked and brought back to their destination (hospitalized participants will be returned to Shalvata Hospital). Participants will receive 200 NIS for transportation and time loss. Participants that will be screened out during the evaluation stage will receive 50 NIS for transportation and time loss.
- Conditions
- Schizophrenia, Healthy
- Being tested
- Magnetoencephalography
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnetoencephalographyOther
Also called MEG, 4D-NeuroImage
Magnetoencephalography is a non-invasive technique for investigating human brain activity. It allows the measurement of ongoing brain activity on a millisecond-by-millisecond basis, and it shows where in the brain activity is produced.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia | Individuals with schizophrenia Receives: Other: Magnetoencephalography | |
| Control | Neurotypical individuals Receives: Other: Magnetoencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain responses to early visual and auditory stimuli as measured by the MEG
Amplitudes and brain sources of early auditory and visual components as measured by the MEG
Measured: Immediate
Secondary outcomes (2)
Correlation between brain responses to early visual and auditory processing and brain patterns of affect perception
Measured: Immediate
Correlation between brain responses to early visual and auditory processing and social functioning and quality of life questionnaire' grades
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2018 (estimated)
- Study completionDec 2019 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bar-Ilan University, Israel
- Responsible party
- Sponsor
- Investigators
- Yuval Bloch, MD, Principal investigator, Shalvata Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588014
- Sponsor's protocol ID
- 0018-15-SHA
- Status last verified
- Oct 2015
- First submitted
- 26 Oct 2015
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Neural Bases of Early Visual and Auditory Processing and Emotion Recognition Deficits in Schizophrenia Using Magnetoencephalography
- ClinicalTrials.gov ID
- NCT02588014
- Acronym / sponsor ID
- 0018-15-SHA
- Conditions
- Schizophrenia, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Collaborators
- Bar-Ilan University, Israel
- Study start
- Nov 2015
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 27 Oct 2015 (estimated)
- 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 purpose of this project is to examine potential mechanisms that may underlie early visual and auditory perception as well as visual and auditory affect perception deficits in schizophrenia and the possible connection between these processes. Given that affect perception largely involves visual and/or auditory information processing and likely relies on intact basic visual and/or auditory perceptual mechanisms, the investigators will examine affect perception deficits within the framework of the more basic visual and auditory processes. Specifically, the investigators will examine magnetophysiological correlates of vocal and visual affect discrimination, non-affective face discrimination and voice discrimination, and simple visual and auditory stimulus discrimination, using Magnetoencephalography (MEG), to identify neural mechanisms underlying perceptual deficits, as well as their contribution to affect perception deficits in schizophrenia.
Detailed description
Patients will be recruited from Shalvata mental health center and evaluated clinically in Shalvata mental health center. The MEG scan will take place at Bar-Ilan University at the Brain Research Center. Participants will get to and from the university with one of the researchers. Patients from the closed ward will be taken from Shalvata mental health center after receiving a signed letter from a relevant staff member allowing them to leave the hospital for the purpose of the research. At the end of the experiment hospitalized patients will be returned to the hospital and non-hospitalized ones to their preferred destination.
First stage (to take place in Shalvata): After the informed consent process a clinical evaluation will be performed. The evaluation will be administered to all participants and will include: demographic details and psychiatric history questionnaire, social functioning scale, handedness questionnaire, four-factor index of social statues for socioeconomic evaluation, Ischihara Color Blindness Test, Snellen wall chart for visual evaluation, TONI-3 test for intelligence evaluation, Hebrew version of the Manchester Short Assessment of Quality of Life, Interpersonal Reaction Index for empathy evaluation, and SCID for DSM-IV. In addition, the PANSS questionnaire will be administered to schizophrenic and schizoaffective patients. Time estimation: 1-2 hours.
Second stage (to take place at Bar-Ilan University and if necessary to be divided into two separate visits): Conducting a brain scan during a battery of tasks that will test neural mechanisms underlying visual and auditory perceptual deficits, as well as their contribution to affect perception deficits in schizophrenia at different levels of the visual and auditory processing. This stage will begin with a preparation for the scan (10-20 minutes) and then the following tasks will take place: Task 1. Gratings Perception task in which participants have to detect the 5% vertical gratings. The aim of this task is to identify the neural mechanisms underlying basic visual perceptual deficits in individuals with schizophrenia by probing the M- and P-pathways using HSF and LSF in a neutral, semantically meaningless, stimuli (~3 minutes); Task 2. Basic Color Processing Task - participants will have to detect 5% of white backgrounds among 180 red, green and gray backgrounds. The aim of this task is to asses neural mechanisms underlying basic visual perception by probing the M- and P pathways using basic color stimuli (~3minutes); Task 3. Orientation Detection Task - a task designed to identify another level of visual processing complexity, in which participants are asked to detect a missing gap in a square, displaying on green, red or gray background (~2 minutes); Task 4. Oddball Task in which participants have to detect infrequent sounds and ignore frequent and novel sounds. The aim of this task is to identify the basic neural mechanisms underlying auditory perception in individuals with schizophrenia (~13 minutes); Task 5. High and low spatial frequency facial expressions perception task. In this task participants have to identify the facial expression of the target stimuli out of three possible expressions: neutral facial expression, happy facial expression and afraid facial expression. The aim of this task is to identify the neural mechanisms underlying neutral facial perception deficit as well as affect perception deficit in individuals with schizophrenia by probing the M- and P-pathways using HSF and LSF facial stimuli (~25 minutes including breaks). Task 6. Colored Face Recognition task - Face stimuli are the same as the broad band stimuli from the previous task with one difference: faces are colored and surrounded by red, green or gray colored backgrounds. Procedure is the same as in the previous task (~25 minutes including breaks); Task 7. Processing of Affective Human Voices task in which participants have to detect and identify the content of human sounds (~15 minutes). Time estimation of the second stage of the experiment is about two hours including breaks. Total time estimation of both experimental stages: Four hours.
At the end of the experiment participants will be thanked and brought back to their destination (hospitalized participants will be returned to Shalvata Hospital). Participants will receive 200 NIS for transportation and time loss. Participants that will be screened out during the evaluation stage will receive 50 NIS for transportation and time loss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | – | Other: MagnetoencephalographyIndividuals with schizophrenia |
| Control | – | Other: MagnetoencephalographyNeurotypical individuals |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals diagnosed with schizophrenia
Key inclusion criteria (13 listed)
- Capable and willing to provide informed consent
- Diagnosis of schizophrenia or schizoaffective
- Right handedness
- Corrected visual acuity
- No color blindness
Key exclusion criteria (17 listed)
- Left handedness
- Intellectual Disability
- Impaired vision
- Impaired hearing
- Colour blindness
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 |
|---|---|---|
| MagnetoencephalographyAlso: MEG, 4D-NeuroImageMagnetoencephalography is a non-invasive technique for investigating human brain activity. It allows the measurement of ongoing brain activity on a millisecond-by-millisecond basis, and it shows where in the brain activity is produced. | Other | Control, Schizophrenia |
Primary outcome
Brain responses to early visual and auditory stimuli as measured by the MEG
Time frame: Immediate
Amplitudes and brain sources of early auditory and visual components as measured by the MEG
2 secondary outcomes
Correlation between brain responses to early visual and auditory processing and brain patterns of affect perception
Time frame: Immediate
Correlation between brain responses to early visual and auditory processing and social functioning and quality of life questionnaire' grades
Time frame: Immediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
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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. This study is not recruiting at the moment.
Yuval Bloch, MD principal investigator
Shalvata Mental Health Center
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Healthy, run by Shalvata Mental Health Center.
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 13 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuval Bloch, MD (+972 97478644, yuvalbloch10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain responses to early visual and auditory stimuli as measured by the MEG (time frame: Immediate). 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 27 Oct 2015.