Schizophrenic DisordersGRASPNCT02655172
Have a Good Grasp of the Worldthe World
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
Brief 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. Read more about this study
- Who is it for?
- Ages 18 to 55 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
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2016to 3 Apr 2019
- 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 55 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
- For patients and control group • Age ≥ 18 years et ≤ 55 years
Who cannot join
- 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);
- For patients:
- IQ < 70
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- For patients and control group
- 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 Action and Perception in Schizophrenia, " Have a Good Grasp of the World "
Brief 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. 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 potentially associated actions (Gibson, 1977, 1979) explored by Stimulus Response Compatibility (SRC) paradigm. With Tucker \& Ellis sensory motor compatibility task (1998), with a modified response device (responses given with grasp), we study the impact of motor activation on these affordance effects. In this study, a group of controls will also be included in order to understand, as precisely as possible, the mechanisms involved (i.e., interference between the perception of the object and the response gesture).
Read the detailed description
Schizophrenic patients will perform: 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 perform the laterality questionnaire. Then all will perform the affordance task, in which photographs of 20 objects of everyday life, typically graspable with one hand, are presented in 4 orientations. Participants have to respond in a graspable device, as quickly as possible, if the object is presented upright or inverted.
- Conditions
- Schizophrenic Disorders
- Being tested
- cognitive tasks + PANSS+ IQ, cognitive tasks
- Keywords
- Schizophrenia, affordance,, perception-action binding,, stimulus-response-compatibility
- 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 perform different 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) + the experimental task (affordance task with graspable device)
cognitive tasksOther
Healthy volunteers will perform only Edinburgh laterality questionnaire (Oldfield, 1971) + the experimental task (affordance task with graspable device).
| 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 posted13 Jan 2016 (estimated)
- Study start24 May 2016
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
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.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne GROSSELIN, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655172
- Sponsor's protocol ID
- 1508205
- Other IDs
- 2015-A01939-40
- Acronym
- GRASP
- Status last verified
- Sep 2019
- First submitted
- 12 Jan 2016
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Links Between Action and Perception in Schizophrenia, " Have a Good Grasp of the World "
- ClinicalTrials.gov ID
- NCT02655172
- Acronym / sponsor ID
- GRASP / 1508205
- Conditions
- Schizophrenic Disorders
- Keywords
- Schizophrenia, affordance,, perception-action binding,, stimulus-response-compatibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 24 May 2016 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 13 Jan 2016 (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.
Brief 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. 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 potentially associated actions (Gibson, 1977, 1979) explored by Stimulus Response Compatibility (SRC) paradigm. With Tucker \& Ellis sensory motor compatibility task (1998), with a modified response device (responses given with grasp), we study the impact of motor activation on these affordance effects. In this study, a group of controls will also be included in order to understand, as precisely as possible, the mechanisms involved (i.e., interference between the perception of the object and the response gesture).
Detailed description
Schizophrenic patients will perform: 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 perform the laterality questionnaire. Then all will perform the affordance task, in which photographs of 20 objects of everyday life, typically graspable with one hand, are presented in 4 orientations. Participants have to respond in a graspable device, as quickly as possible, if the object is presented upright or inverted.
Study design
- Primary purpose
- Other
- 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 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- For patients:
- For patients and control group • Age ≥ 18 years et ≤ 55 years
Key exclusion criteria (11 listed)
- 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);
- For patients:
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 perform different 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) + the experimental task (affordance task with graspable device) | Other | Patients |
| cognitive tasksHealthy volunteers will perform only Edinburgh laterality questionnaire (Oldfield, 1971) + the experimental task (affordance task with graspable device). | 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 6 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Anne GROSSELIN, MD principal investigator
Centre Hospitalier Universitaire 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 4 inclusion and 11 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 6 Sep 2019. 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 6 Sep 2019.