Autism Spectrum DisordersNCT00914030
Visual Exploration and Attention: Studies in Patients With Schizophrenia and Autism Spectrum Disorders
An observational study of Autism Spectrum Disorders and Schizophrenia, run by University Hospital, Strasbourg, France at 5 sites in France.
Trial summary
The aim of the protocol is to better understand the impairments in visual processing, as such impairments may induce social interaction difficulties in subjects with autism spectrum disorders (adults and children) and schizophrenia, like face exploration.The same protocol will be used for the three populations, each… Read more about this study
- Who is it for?
- Ages 7 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders, Schizophrenia
- What is being tested?
- Neuropsychological evaluation
- How many people
- 140 participants
- Where
- 5 sitesFrance
- Study dates
- Jun 2009to Dec 2016
- 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 7 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Psychiatry clinic in Strasbourg and Brumath. Pedopsychiatry Clinic in Strasbourg. Residents of Strasbourg and Brumath
Who may be able to join
- IQ above 70, as evaluated with the WAIS III in adults and with the WISC in children
- signed consent
- DSM IV criteria in case of autism spectrum disorders or schizophrenia
Who cannot join
- grave or non stabilized somatic pathology
- pathology affecting the central nervous system; other than the studied pathologies
- intake of psychotropic drug, except for patients
- invalidating sensory processes
Trial locations and contacts
5 sites in 1 country.
GIERSCH Anne, MD contact
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Pôle départemental du Centre de Ressources Autisme pour adultes (67) - Etablissement public de santé Alsace-Nord (site de Brumath)
Brumath, 67170
HOCHNER Arielle, MD, arielle.hochner@ch-epsan.fr
HOCHNER Arielle, MD
- Recruiting
Centre de Ressources Autisme Pôle adultes (68) - Espace Autisme 68
Colmar, 68000
MURAD Ayman, MD, murad@ch-rouffach.fr
MURAD Ayman, MD
- Recruiting
Clinique Lautréamont
Loos, 59120
GONIN Olivier, MD, Olivier.gonin4@wanadoo.fr
GONIN Olivier, MD
- Recruiting
Pôle régional du Centre de Ressources Autisme pour enfants et adolescents - Unité d'évaluation des troubles du développement Hôpital de l'Elsau - Pôle de Psychiatrie - Unité d'évaluation des troubles du développement Hôpital de l'Elsau - HUS
Strasbourg, 67000
GRAS-VINCENDON Agnès, MD, agnes.gras@chru-strasbourg.fr
GRAS-VINCENDON Agnès, MD
- Recruiting
INSERM U666 ; Pôle de Psychiatrie - Service de Psychiatrie Adulte- HUS
Strasbourg, 67091
GIERSCH Anne, MD, giersch@unistra.fr
GIERSCH Anne, MD
About this study
Official title: Visual Exploration and Attention : Studies in Patients With Schizophrenia and Autism Spectrum Disorders
The aim of the protocol is to better understand the impairments in visual processing, as such impairments may induce social interaction difficulties in subjects with autism spectrum disorders (adults and children) and schizophrenia, like face exploration.The same protocol will be used for the three populations, each population being compared with matched controls. The explorations are designed to test two different hypotheses regarding the mechanisms of the visual perception difficulties of the two populations. Even though difficulties to extract the global form of objects have been described in both subjects with autism and schizophrenia, we will test two different hypotheses for the two populations. We will test the hypothesis that subjects with autism display an advantage for the processing of local information arising at an early level of processing, whereas disorders observed in patients with schizophrenia originate from attention disorders. The protocol includes three consecutive studies, each one being applied in each of the three populations.
- Conditions
- Autism Spectrum Disorders, Schizophrenia
- Being tested
- Neuropsychological evaluation
- Keywords
- Visual perception, Local/global processing, Attention, Visual priming, Collinearity, Grouping
- Medical subject headings
- Autism Spectrum Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological evaluationOther
Also called Each study will be conducted successively in each group (A1/ A2, B1/B2, C1/C2).
Study one: global/local processing, with a neutral prime (stimulus influencing the processing of the subsequent stimulus)Study two: global/ local processing with a prime whose elements are collinear.Study three: global/local processing with a prime whose elements are not collinear
| Study group | Role | What they receive |
|---|---|---|
| A1 | Patients with schizophrenia Receives: Other: Neuropsychological evaluation | |
| A2 | Control subjects matched individually with patients with schizophrenia Receives: Other: Neuropsychological evaluation | |
| B1 | Adult subjects with autism Receives: Other: Neuropsychological evaluation | |
| B2 | Control subjects matched individually with adult subjects with autism Receives: Other: Neuropsychological evaluation | |
| C1 | Children with autism Receives: Other: Neuropsychological evaluation | |
| C2 | Control subjects matched individually with children with autism Receives: Other: Neuropsychological evaluation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne GIERSCH, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914030
- Sponsor's protocol ID
- 2008-A01459-46
- Status last verified
- Aug 2016
- First submitted
- 2 Jun 2009
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Exploration and Attention : Studies in Patients With Schizophrenia and Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT00914030
- Acronym / sponsor ID
- 2008-A01459-46
- Conditions
- Autism Spectrum Disorders, Schizophrenia
- Keywords
- Visual perception, Local/global processing, Attention, Visual priming, Collinearity, Grouping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 4 Jun 2009 (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 the protocol is to better understand the impairments in visual processing, as such impairments may induce social interaction difficulties in subjects with autism spectrum disorders (adults and children) and schizophrenia, like face exploration.The same protocol will be used for the three populations, each population being compared with matched controls. The explorations are designed to test two different hypotheses regarding the mechanisms of the visual perception difficulties of the two populations. Even though difficulties to extract the global form of objects have been described in both subjects with autism and schizophrenia, we will test two different hypotheses for the two populations. We will test the hypothesis that subjects with autism display an advantage for the processing of local information arising at an early level of processing, whereas disorders observed in patients with schizophrenia originate from attention disorders. The protocol includes three consecutive studies, each one being applied in each of the three populations.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A1 | – | Other: Neuropsychological evaluationPatients with schizophrenia |
| A2 | – | Other: Neuropsychological evaluationControl subjects matched individually with patients with schizophrenia |
| B1 | – | Other: Neuropsychological evaluationAdult subjects with autism |
| B2 | – | Other: Neuropsychological evaluationControl subjects matched individually with adult subjects with autism |
| C1 | – | Other: Neuropsychological evaluationChildren with autism |
| C2 | – | Other: Neuropsychological evaluationControl subjects matched individually with children with autism |
Who may qualify
- Ages
- 7 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Psychiatry clinic in Strasbourg and Brumath. Pedopsychiatry Clinic in Strasbourg. Residents of Strasbourg and Brumath
Key inclusion criteria (3 listed)
- IQ above 70, as evaluated with the WAIS III in adults and with the WISC in children
- signed consent
- DSM IV criteria in case of autism spectrum disorders or schizophrenia
Key exclusion criteria (4 listed)
- grave or non stabilized somatic pathology
- pathology affecting the central nervous system; other than the studied pathologies
- intake of psychotropic drug, except for patients
- invalidating sensory processes
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 |
|---|---|---|
| Neuropsychological evaluationAlso: Each study will be conducted successively in each group (A1/ A2, B1/B2, C1/C2).Study one: global/local processing, with a neutral prime (stimulus influencing the processing of the subsequent stimulus)Study two: global/ local processing with a prime whose elements are collinear.Study three: global/local processing with a prime whose elements are not collinear | Other | A1, A2, B1, B2, C1, C2 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 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.
GIERSCH Anne, MD contact
Anne GIERSCH principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorders and Schizophrenia, run by University Hospital, Strasbourg, France at 5 sites 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 4 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 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GIERSCH Anne, MD (giersch@unistra.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 26 Aug 2016.