SchizophreniaNCT01375894
Body Movement Imitation and Perspective Perception Among Psychiatric Patients
A study testing imitation assessment using the 5-dt "data glove". in people with Schizophrenia and Depression, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
The ability to understand the other's perspective and respond accordingly is the most important normal process of daily social life and is probably one of the foundations of human existence. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia, Depression
- What is being tested?
- imitation assessment using the 5-dt "data glove".
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2012to Dec 2012
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 20-65.
- Subjects who met the criteria for diagnosis of major DSM-IV for schizophrenia or unipolar depression.
- Subjects with normal or corrected vision.
- Subjects who sign informed consent for their participation in the experiment
Who cannot join
- Patients with acute disorder, or an unstable patient. Especially neurological disorders or head injuries.
- Drug Abuse in the past year.
- Lack of jurisdiction, such as people with mental retardation or dementia.
- assessed with high suicide risk.
- patients which are Compulsory hospitalized.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Israel1 site
Shalvata MHC
Hod HaSharon
Hilik Levkovitz, prof., 09-7478644, ylevk@clalit.org.il
Hilik Levkovitz, prof.
About this study
The ability to understand the other's perspective and respond accordingly is the most important normal process of daily social life and is probably one of the foundations of human existence. This capability is reflected, inter alia, as an imitation - an important and effective form of learning which is very developed in humans. When we are required to imitate a particular movement, speed of response depends on the perspective of the movement. Imitative response is implemented faster when the movement is observed from first-person perspective, than if the motion is presented from the perspective of a third party.
While healthy individuals don't find it difficult to imitate, or to understand the other's emotion expression, there are psychiatric populations (such as autism and schizophrenia) who find it difficult to demonstrate these capabilities (Park, Matthews et al. 2008). Beyond these capabilities impairment, schizophrenic patients have difficulty distinguishing between their arm movements and those of a foreign hand and find it difficult to leave the boundaries of egocentric interpretation of reality and adopt the other's point of view. These behavioral disorders arise from defects in the network of mirror neurons (Buccino and Amore 2008; Langdon, Coltheart et al. 2010).
Therefore, the investigator expect that schizophrenic patients will not see a preference for movements that will be displayed in first-person perspective from the same movements that will be displayed from the perspective of a third party. Consequently, the investigator speculate that these subjects will not exhibit differences at imitating the response of which will be presented from different perspectives (Jackson, Meltzoff et (al. 2006.
- Conditions
- Schizophrenia, Depression
- Being tested
- imitation assessment using the 5-dt "data glove".
- Medical subject headings
- Schizophrenia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imitation assessment using the 5-dt "data glove".Device
measuring the speed of the hand during imitation
| Study group | Role | What they receive |
|---|---|---|
| depresive patients | Active comparator | 30 patients suffering from depression Receives: Device: imitation assessment using the 5-dt "data glove". |
| Schizophrenia patients | Experimental | 30 Schizophrenia patients Receives: Device: imitation assessment using the 5-dt "data glove". |
What is being measured
The primary outcome is the main question the study is designed to answer.
speed of hand movement according to the reaction glove
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startMar 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
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
- NCT01375894
- Sponsor's protocol ID
- SHA-07-11
- Status last verified
- Dec 2011
- First submitted
- 14 Jun 2011
- Last updated
- 2 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Movement Imitation and Perspective Perception Among Psychiatric Patients
- ClinicalTrials.gov ID
- NCT01375894
- Acronym / sponsor ID
- SHA-07-11
- Conditions
- Schizophrenia, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 17 Jun 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 ability to understand the other's perspective and respond accordingly is the most important normal process of daily social life and is probably one of the foundations of human existence. This capability is reflected, inter alia, as an imitation - an important and effective form of learning which is very developed in humans. When we are required to imitate a particular movement, speed of response depends on the perspective of the movement. Imitative response is implemented faster when the movement is observed from first-person perspective, than if the motion is presented from the perspective of a third party.
While healthy individuals don't find it difficult to imitate, or to understand the other's emotion expression, there are psychiatric populations (such as autism and schizophrenia) who find it difficult to demonstrate these capabilities (Park, Matthews et al. 2008). Beyond these capabilities impairment, schizophrenic patients have difficulty distinguishing between their arm movements and those of a foreign hand and find it difficult to leave the boundaries of egocentric interpretation of reality and adopt the other's point of view. These behavioral disorders arise from defects in the network of mirror neurons (Buccino and Amore 2008; Langdon, Coltheart et al. 2010).
Therefore, the investigator expect that schizophrenic patients will not see a preference for movements that will be displayed in first-person perspective from the same movements that will be displayed from the perspective of a third party. Consequently, the investigator speculate that these subjects will not exhibit differences at imitating the response of which will be presented from different perspectives (Jackson, Meltzoff et (al. 2006.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| depresive patients | Active comparator | Device: imitation assessment using the 5-dt "data glove".30 patients suffering from depression |
| Schizophrenia patients | Experimental | Device: imitation assessment using the 5-dt "data glove".30 Schizophrenia patients |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged 20-65.
- Subjects who met the criteria for diagnosis of major DSM-IV for schizophrenia or unipolar depression.
- Subjects with normal or corrected vision.
- Subjects who sign informed consent for their participation in the experiment
Key exclusion criteria (6 listed)
- Patients with acute disorder, or an unstable patient. Especially neurological disorders or head injuries.
- Drug Abuse in the past year.
- Lack of jurisdiction, such as people with mental retardation or dementia.
- assessed with high suicide risk.
- patients which are Compulsory hospitalized.
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 |
|---|---|---|
| imitation assessment using the 5-dt "data glove".measuring the speed of the hand during imitation | Device | Schizophrenia patients, depresive patients |
Primary outcome
speed of hand movement according to the reaction glove
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing imitation assessment using the 5-dt "data glove". in people with Schizophrenia and Depression, 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 4 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: status not confirmed, as of the sponsor's last update on 2 Jan 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 Hilik Levkovitz, prof. (09-7478644, ylevk@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
speed of hand movement according to the reaction glove (time frame: 30 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 2 Jan 2012.