Schizophrenic PatientsNCT01550211
Changes in Brain Synchronization During Perceptual and Linguistic Tasks in Schizophrenic Patients
An observational study of Schizophrenic Patients, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
This study aims to identify electrophysiological correlates of impaired perceptual and linguistic processes in chronic schizophrenic patients, un-medicated first-episode schizophrenic patients and their healthy relatives. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenic Patients
- What is being tested?
- Magnetoencephalograph (MEG)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2012to Mar 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Chronic patients - Up to 30 chronic schizophrenic patients. 2. Naive patients - Up to 30 unmedicated first episode schizophrenic patients. 3. Patients' relatives - Up to 60 family members (parents or siblings) of the participants - control group 1. 4. Students - Up to 30 students from Bar-Ilan University - control group 2.
Who may be able to join
- Hebrew native speakers.
- Diagnosis of schizophrenia with a history of more than one episode.
- Capable and willing to provide informed consent.
- Hebrew native speakers.
- Diagnosis of schizophrenia with a history of only one episode and unmedicated.
- Capable and willing to provide informed consent.
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- Inclusion criteria for patients' relatives (control group 1):
- Hebrew native speakers.
- Without any psychiatric history.
- Have a child and/or a sibling with schizophrenia.
- Hebrew native speakers.
- Without any psychiatric history.
Who cannot join
- Exclusion Criteria for patient groups (chronic and "naïve"):
- Left handedness.
- Reading disability.
- Visual perception disability.
- Brain damage and/or a history of seizures.
- Impaired intelligence.
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- Metal implants.
- Exclusion Criteria for control groups (family members and students):
- Psychiatric history.
- Left handedness.
- Reading disability.
- Visual perception disability.
- Brain damage and/or a history of seizures.
- Impaired intelligence.
- Metal implants.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Shalvata MHC
Hod HaSharon
Maor Zeev-Wolf, M.A., 972-50-7737032, maorwolf@gmail.com
Maor Zeev-Wolf, M.A.
About this study
This study aims to identify electrophysiological correlates of impaired perceptual and linguistic processes in chronic schizophrenic patients, un-medicated first-episode schizophrenic patients and their healthy relatives.
Following administrating some questionnaires (demographic details and psychiatric history questionnaire, handedness questionnaire, reading abilities test and positive and negative symptoms questionnaire) and performing a perception test and a verbal abstract intelligence test, participants will conduct a brain scan during a series of perceptual and linguistic tasks.
- Conditions
- Schizophrenic Patients
- Being tested
- Magnetoencephalograph (MEG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetoencephalograph (MEG)Device
Conducting a brain scan during a series of perceptual and linguistic tasks
| Study group | Role | What they receive |
|---|---|---|
| Students | Healthy students from Bar-Ilan University Receives: Device: Magnetoencephalograph (MEG) | |
| Schizophrenic patients' relatives | Healthy family members (parents or siblings) of the schizophrenic participants (chronic and naive) Receives: Device: Magnetoencephalograph (MEG) | |
| Naive schizophrenic patients | Naive patients with a diagnosis of schizophrenia, a history of only one psychotic episode and un-medicated Receives: Device: Magnetoencephalograph (MEG) | |
| Chronic schizophrenia patients | Chronic patients with a diagnosis of schizophrenia and a history of more than one psychotic episode Receives: Device: Magnetoencephalograph (MEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic field amplitude and source
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenic PatientsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 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
- Hilik Levkovitz, Professor, Principal investigator, Shalvata MHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550211
- Sponsor's protocol ID
- SHA-0001-12
- Status last verified
- Mar 2012
- First submitted
- 7 Mar 2012
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Brain Synchronization During Perceptual and Linguistic Tasks in Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT01550211
- Acronym / sponsor ID
- SHA-0001-12
- Conditions
- Schizophrenic Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Collaborators
- Bar-Ilan University, Israel
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (estimated)
- First posted
- 9 Mar 2012 (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.
This study aims to identify electrophysiological correlates of impaired perceptual and linguistic processes in chronic schizophrenic patients, un-medicated first-episode schizophrenic patients and their healthy relatives.
Following administrating some questionnaires (demographic details and psychiatric history questionnaire, handedness questionnaire, reading abilities test and positive and negative symptoms questionnaire) and performing a perception test and a verbal abstract intelligence test, participants will conduct a brain scan during a series of perceptual and linguistic tasks.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Students | – | Device: Magnetoencephalograph (MEG)Healthy students from Bar-Ilan University |
| Schizophrenic patients' relatives | – | Device: Magnetoencephalograph (MEG)Healthy family members (parents or siblings) of the schizophrenic participants (chronic and naive) |
| Naive schizophrenic patients | – | Device: Magnetoencephalograph (MEG)Naive patients with a diagnosis of schizophrenia, a history of only one psychotic episode and un-medicated |
| Chronic schizophrenia patients | – | Device: Magnetoencephalograph (MEG)Chronic patients with a diagnosis of schizophrenia and a history of more than one psychotic episode |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Chronic patients - Up to 30 chronic schizophrenic patients. 2. Naive patients - Up to 30 unmedicated first episode schizophrenic patients. 3. Patients' relatives - Up to 60 family members (parents or siblings) of the participants - control group 1. 4. Students - Up to 30 students from Bar-Ilan University - control group 2.
Key inclusion criteria (12 listed)
- Hebrew native speakers.
- Diagnosis of schizophrenia with a history of more than one episode.
- Capable and willing to provide informed consent.
- Hebrew native speakers.
- Diagnosis of schizophrenia with a history of only one episode and unmedicated.
Key exclusion criteria (15 listed)
- Left handedness.
- Reading disability.
- Visual perception disability.
- Brain damage and/or a history of seizures.
- 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)Conducting a brain scan during a series of perceptual and linguistic tasks | Device | Chronic schizophrenia patients, Naive schizophrenic patients, Schizophrenic patients' relatives, Students |
Primary outcome
Magnetic field amplitude and source
Time frame: 45 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 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.
Hilik Levkovitz, Professor principal investigator
Shalvata MHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenic Patients, 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 12 inclusion and 15 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 9 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maor Zeev-Wolf, M.A. (972-50-7737032, maorwolf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic field amplitude and source (time frame: 45 minutes). 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 9 Mar 2012.