SchizophreniaNCT01325363
Magnetoencephalographic (MEG) Evidence for Novel Metaphor Processing Among Schizophrenic Patients
A study testing Magnetoencephalograph (MEG) in people with Schizophrenia and Novel Metaphor, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
The aim of this research is to investigate the neurolinguistic mechanisms underlying thought disorders among schizophrenic patients. In particular, it will investigate the neurolinguistic basis for loose association - a phenomena which this population is characterized by. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Novel Metaphor
- What is being tested?
- Magnetoencephalograph (MEG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to Dec 2011
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Schizophrenic patients according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV) or International Classification of Diseases (ICD-10)
- Hebrew native speakers
Who cannot join
- Language disabilities
- Left handed
- Reading disabilities
- Brain damage
- Impaired intelligence
- Metal implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Metaphor Processing Among Schizophrenic Patients - Magnetoencephalographic (MEG) Evidence
The aim of this research is to investigate the neurolinguistic mechanisms underlying thought disorders among schizophrenic patients. In particular, it will investigate the neurolinguistic basis for loose association - a phenomena which this population is characterized by. Several researchers have previously suggested that loose associations among schizophrenic patients relate to a lack of inhibition in the automatic spread of activation mechanisms within semantic networks (e.g., Soriano, Jimenez, Roman, \& Bajo, 2008). This research focuses on the relationship between I. the left-right hemisphere dynamic and II. semantic processing, among schizophrenic patients. The research follows Jung-Beeman's (2005) model which relates semantic associations, activation and inhibition processes to the functioning of the two cerebral hemispheres.
Previous research suggests that, when compared to the neurotypical population, people with schizophrenia show a less defined - or even reversed - hemispheric lateralization pattern for semantic processing. This is linked to an impairment in language function in the left hemisphere, and to a language functions shift from left to right hemisphere (e.g., Crow, 1997). The investigators assume that this unique lateralization pattern may cause a change in balance in the semantic activation and inhibition system among schizophrenic patients.
Read more
As stated, one of the linguistic models that predicts how reduced left hemisphere dominancy will influence linguistic functioning is Jung-Beeman's (2005) bilateral model for language understanding. According to this model, the left hemisphere specializes in precise and fine semantic processing, while the right hemisphere specializes in coarse and abstract semantic processing. Building upon this distinction, our assumption is that schizophrenic patients experience a difficulty in fine semantic processing which is caused by functional impairment in the left hemisphere. It is our further assumption that coarse semantic processing - located in the right hemisphere - is relatively unimpaired. This change in the balance between the two processes may have direct implications on the associative semantic network among schizophrenic patients.
In order to test this hypothesis, the current research will make use of a specific language expression type which involves fine and coarse semantic processing, and for which there is evidence for crucial right hemisphere involvement: novel metaphor processing. 10-20 adult schizophrenic patients will be presented with four different types of two word expressions: literal; conventional metaphor; novel metaphor and unrelated. The patients will have to decide as quickly and accurately as possible if the expression is meaningful or meaningless while their brain activity is recorded by a Magnetoencephalographic (MEG) device (which combines a high temporal resolution with the ability to localize the activity).
Therefore, our main hypothesis is that schizophrenic patients will show a bilateral brain activity pattern when conducting semantic decisions, and that this pattern will be related to improved reaction times and accuracy when presented with novel metaphors than when presented with other types of expressions.
- Conditions
- Schizophrenia, Novel Metaphor
- Being tested
- Magnetoencephalograph (MEG)
- Keywords
- Schizophrenia, Novel metaphor
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetoencephalograph (MEG)Device
Also called MAGNES STIMULUS, 4-D NEUROIMAGING, 9727 Pacific heights blvd., San Diego, CA 92121, USA.
Brain imaging device that records the magnetic fields in the brain.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia | Experimental | Schizophrenic patients Receives: Device: Magnetoencephalograph (MEG) |
| Control | Experimental | Neurotypical subjects Receives: Device: Magnetoencephalograph (MEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude power and source location of the magnetic brain activity
Magnetic brain activity which was recorded during the experimental task, will be cleaned from artifacts, averaged over participants and then the amplitude power of each condition in each group will be calculated for different time windows. In a subsequent analysis, the source location of the activity will be calculated using Beamforming techniques.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionDec 2011
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325363
- Sponsor's protocol ID
- SHA-11-0006
- Status last verified
- Mar 2012
- First submitted
- 27 Mar 2011
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Metaphor Processing Among Schizophrenic Patients - Magnetoencephalographic (MEG) Evidence
- ClinicalTrials.gov ID
- NCT01325363
- Acronym / sponsor ID
- SHA-11-0006
- Conditions
- Schizophrenia, Novel Metaphor
- Keywords
- Schizophrenia, Novel metaphor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Mar 2011 (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 aim of this research is to investigate the neurolinguistic mechanisms underlying thought disorders among schizophrenic patients. In particular, it will investigate the neurolinguistic basis for loose association - a phenomena which this population is characterized by. Several researchers have previously suggested that loose associations among schizophrenic patients relate to a lack of inhibition in the automatic spread of activation mechanisms within semantic networks (e.g., Soriano, Jimenez, Roman, \& Bajo, 2008). This research focuses on the relationship between I. the left-right hemisphere dynamic and II. semantic processing, among schizophrenic patients. The research follows Jung-Beeman's (2005) model which relates semantic associations, activation and inhibition processes to the functioning of the two cerebral hemispheres.
Previous research suggests that, when compared to the neurotypical population, people with schizophrenia show a less defined - or even reversed - hemispheric lateralization pattern for semantic processing. This is linked to an impairment in language function in the left hemisphere, and to a language functions shift from left to right hemisphere (e.g., Crow, 1997). The investigators assume that this unique lateralization pattern may cause a change in balance in the semantic activation and inhibition system among schizophrenic patients.
As stated, one of the linguistic models that predicts how reduced left hemisphere dominancy will influence linguistic functioning is Jung-Beeman's (2005) bilateral model for language understanding. According to this model, the left hemisphere specializes in precise and fine semantic processing, while the right hemisphere specializes in coarse and abstract semantic processing. Building upon this distinction, our assumption is that schizophrenic patients experience a difficulty in fine semantic processing which is caused by functional impairment in the left hemisphere. It is our further assumption that coarse semantic processing - located in the right hemisphere - is relatively unimpaired. This change in the balance between the two processes may have direct implications on the associative semantic network among schizophrenic patients.
In order to test this hypothesis, the current research will make use of a specific language expression type which involves fine and coarse semantic processing, and for which there is evidence for crucial right hemisphere involvement: novel metaphor processing. 10-20 adult schizophrenic patients will be presented with four different types of two word expressions: literal; conventional metaphor; novel metaphor and unrelated. The patients will have to decide as quickly and accurately as possible if the expression is meaningful or meaningless while their brain activity is recorded by a Magnetoencephalographic (MEG) device (which combines a high temporal resolution with the ability to localize the activity).
Therefore, our main hypothesis is that schizophrenic patients will show a bilateral brain activity pattern when conducting semantic decisions, and that this pattern will be related to improved reaction times and accuracy when presented with novel metaphors than when presented with other types of expressions.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | Experimental | Device: Magnetoencephalograph (MEG)Schizophrenic patients |
| Control | Experimental | Device: Magnetoencephalograph (MEG)Neurotypical subjects |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Schizophrenic patients according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV) or International Classification of Diseases (ICD-10)
- Hebrew native speakers
Key exclusion criteria (6 listed)
- Language disabilities
- Left handed
- Reading disabilities
- Brain damage
- Impaired intelligence
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 |
|---|---|---|
| Magnetoencephalograph (MEG)Also: MAGNES STIMULUS, 4-D NEUROIMAGING, 9727 Pacific heights blvd., San Diego, CA 92121, USA.Brain imaging device that records the magnetic fields in the brain. | Device | Control, Schizophrenia |
Primary outcome
Amplitude power and source location of the magnetic brain activity
Time frame: one hour
Magnetic brain activity which was recorded during the experimental task, will be cleaned from artifacts, averaged over participants and then the amplitude power of each condition in each group will be calculated for different time windows. In a subsequent analysis, the source location of the activity will be calculated using Beamforming techniques.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetoencephalograph (MEG) in people with Schizophrenia and Novel Metaphor, run by Shalvata Mental Health Center at 1 site in Israel.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude power and source location of the magnetic brain activity (time frame: one hour). 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 8 Mar 2012.