Schizophrenic DisordersNCT02544516
Upside Down, Give me the Handle
A study testing cognitive tasks + PANSS+ IQ and cognitive tasks in people with Schizophrenic Disorders, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
In schizophrenia, dislocation of psychic functions involving a loss of contact with reality is frequently found. A fragmentation of motor and sensory perceptions could be held responsible (Fuchs, 2005). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenic Disorders
- What is being tested?
- cognitive tasks + PANSS+ IQ and cognitive tasks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Oct 2016
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For patients:
- a DSM-IV diagnosis of schizophrenia (men or women),
- no change in antipsychotic medication and clinical status within four weeks prior to the study
Who cannot join
- IQ < 70
- For patients and control group Inclusion criteria
- Age ≥ 18 years et ≤ 50 years
- History of head trauma,
- neurological disease with cerebral repercussion or not stabilized serious physical illness;
- psychotropic medication,
- disorders related to the use of a psychoactive substance (abuse, dependence or withdrawal);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Links Between Perception and Action in Schizophrenia, "Upside Down, Give me the Handle"
In schizophrenia, dislocation of psychic functions involving a loss of contact with reality is frequently found. A fragmentation of motor and sensory perceptions could be held responsible (Fuchs, 2005). However, automatic integration between perception and action is the necessary condition to be in "relationship with the world." Affordance is the experimental link between object perception and actions potentially associated (Gibson (1977, 1979) explored by Stimulus Response Compatibility (SRC) paradigm. The existence of visual motor neurons leads us to postulate that the affordance effect can be assisted by a visuomotor priming of a hand in a position to grasp. With Tucker \& Ellis sensory motor compatibility task, we study the capacity of affordance in schizophrenia, as well as the impact of perceptual motor priming on these affordance effects.
Read the detailed description
All participants will perform cognitive tasks: reaction time (Alert TEA, Zimmermann and Fimm, 2005), Edinburgh laterality questionnaire (Oldfield, 1971), IQ test (IQ: PM38, Raven, 1960), and the PANSS (Positive and Negative Syndrome Scale, Kay et al., 1987). Controls will only have the first three tasks (cognitive spots Alert and laterality). Then all will perform all tasks in successive order (task 1 and task 2). For both tasks, photographs of 20 objects of everyday life typical grip with one hand are presented in 4 orientations. The instruction is to say if the object is presented upright or inverted; The second task differs from the first only by the introduction of a prime: presenting a hand in position "catching" before the picture of an object
- Conditions
- Schizophrenic Disorders
- Being tested
- cognitive tasks + PANSS+ IQ, cognitive tasks
- Keywords
- Schizophrenia, motor and sensory perceptions
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive tasks + PANSS+ IQOther
Patients will have cognitive tasks: reaction time (Alert TEA, Zimmermann and Fimm, 2005), Edinburgh laterality questionnaire (Oldfield, 1971), IQ test (IQ: PM38, Raven, 1960), and the PANSS (Positive and Negative Syndrome Scale, Kay et al., 1987
cognitive tasksOther
Patients will have cognitive tasks: reaction time (Alert TEA, Zimmermann and Fimm, 2005), Edinburgh laterality questionnaire (Oldfield, 1971),
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | patients suffering schizophrenic disorders and who will perform cognitive tasks + PANSS+ IQ Receives: Other: cognitive tasks + PANSS+ IQ |
| control group | Active comparator | healthy patients who will perform cognitive tasks Receives: Other: cognitive tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
response time
The gain provided by the compatible vs incompatible conditions (ms response time)
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startApr 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenic DisordersStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine MASSOUBRE, MD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544516
- Sponsor's protocol ID
- 1308139
- Other IDs
- 2013-A01294-41
- Status last verified
- Nov 2016
- First submitted
- 7 Sep 2015
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Links Between Perception and Action in Schizophrenia, "Upside Down, Give me the Handle"
- ClinicalTrials.gov ID
- NCT02544516
- Acronym / sponsor ID
- 1308139
- Conditions
- Schizophrenic Disorders
- Keywords
- Schizophrenia, motor and sensory perceptions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 9 Sep 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.
In schizophrenia, dislocation of psychic functions involving a loss of contact with reality is frequently found. A fragmentation of motor and sensory perceptions could be held responsible (Fuchs, 2005). However, automatic integration between perception and action is the necessary condition to be in "relationship with the world." Affordance is the experimental link between object perception and actions potentially associated (Gibson (1977, 1979) explored by Stimulus Response Compatibility (SRC) paradigm. The existence of visual motor neurons leads us to postulate that the affordance effect can be assisted by a visuomotor priming of a hand in a position to grasp. With Tucker \& Ellis sensory motor compatibility task, we study the capacity of affordance in schizophrenia, as well as the impact of perceptual motor priming on these affordance effects.
Detailed description
All participants will perform cognitive tasks: reaction time (Alert TEA, Zimmermann and Fimm, 2005), Edinburgh laterality questionnaire (Oldfield, 1971), IQ test (IQ: PM38, Raven, 1960), and the PANSS (Positive and Negative Syndrome Scale, Kay et al., 1987). Controls will only have the first three tasks (cognitive spots Alert and laterality). Then all will perform all tasks in successive order (task 1 and task 2). For both tasks, photographs of 20 objects of everyday life typical grip with one hand are presented in 4 orientations. The instruction is to say if the object is presented upright or inverted; The second task differs from the first only by the introduction of a prime: presenting a hand in position "catching" before the picture of an object
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: cognitive tasks + PANSS+ IQpatients suffering schizophrenic disorders and who will perform cognitive tasks + PANSS+ IQ |
| control group | Active comparator | Other: cognitive taskshealthy patients who will perform cognitive tasks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- a DSM-IV diagnosis of schizophrenia (men or women),
- no change in antipsychotic medication and clinical status within four weeks prior to the study
Key exclusion criteria (7 listed)
- IQ < 70
- For patients and control group Inclusion criteria
- Age ≥ 18 years et ≤ 50 years
- History of head trauma,
- neurological disease with cerebral repercussion or not stabilized serious physical illness;
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 |
|---|---|---|
| cognitive tasks + PANSS+ IQPatients will have cognitive tasks: reaction time (Alert TEA, Zimmermann and Fimm, 2005), Edinburgh laterality questionnaire (Oldfield, 1971), IQ test (IQ: PM38, Raven, 1960), and the PANSS (Positive and Negative Syndrome Scale, Kay et al., 1987 | Other | Patients |
| cognitive tasksPatients will have cognitive tasks: reaction time (Alert TEA, Zimmermann and Fimm, 2005), Edinburgh laterality questionnaire (Oldfield, 1971), | Other | control group |
Primary outcome
response time
Time frame: day 1
The gain provided by the compatible vs incompatible conditions (ms response time)
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 22 Nov 2016.
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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.
Catherine MASSOUBRE, MD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive tasks + PANSS+ IQ and cognitive tasks in people with Schizophrenic Disorders, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 3 inclusion and 7 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 22 Nov 2016. 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 France. 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?
response time (time frame: day 1). 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 22 Nov 2016.