SchizophreniaNCT00350805
Measuring Time Windows in Patients With Schizophrenia and Healthy Controls
An observational study of Schizophrenia, run by University Hospital, Strasbourg, France at 3 sites in France.
Trial summary
Abnormalities in the ability to distinguish events in time may have a great impact on everyday life. The main objective of the study is to evaluate the magnitude of the temporal windows in schizophrenia, i.e. the time interval during which two events are perceived as synchronous. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- EEG
- Type of treatment
- Surgery or procedure
- How many people
- 126 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2005to Dec 2012
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Primary care clinic, residents of Strasbourg
Who may be able to join
- Patients with schizophrenia (DSM-IV criteria)
- Healthy controls matched with patients on age, sex and education level
- Age between 18 and 50
- Informed consent signed
- No severe somatic illness
- No invalidating sensory disease
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- No drug abuse, as defined by DSM-IV criteria
- No general anesthesia in the past 3 months
- No intake of drug affecting the CNS, except for patients
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de Psychiatrie Adulte & INSERM U841, Hôpital Albert Chenevier et Henri Mondor (AP-HP)
Créteil, 94000
Centre Hospitalier de Rouffach
Rouffach, 68250
INSERM U666 - Département de Psychiatrie - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: Relating the 'Experienced Present' With the Mechanisms of Neuronal Function: A Comparative Study in Patients With Schizophrenia and Healthy Controls Using Psychophysical and Neurophysiological Methods
Abnormalities in the ability to distinguish events in time may have a great impact on everyday life. The main objective of the study is to evaluate the magnitude of the temporal windows in schizophrenia, i.e. the time interval during which two events are perceived as synchronous. The investigators test the hypothesis that these temporal windows are enlarged, and check the relationship between this impairment and disorganization symptoms, in order to explore the link between this cognitive impairment and clinical symptoms. They explore also the neurobiological bases of the impairment by means of electroencephalogram (EEG) recordings. Event-related potentials (N50) will reveal whether or not the coding of the stimuli has the same temporal characteristics in patients and controls. The distribution and amplitude of oscillatory activities will be analyzed as a function of the synchronous or asynchronous response of the subject, thus allowing to explore the links between synchrony perception and neuronal synchronization phenomena.
- Conditions
- Schizophrenia
- Being tested
- EEG
- Keywords
- Schizophrenia, Time perception, Cortical synchronization, Electroencephalography
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGProcedure or surgery
One 20 minutes session
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described Receives: Procedure: EEG | |
| Patients | Not described Receives: Procedure: EEG |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2006 (estimated)
- Study startSep 2005
- Primary completionApr 2012
- Study completionDec 2012
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.
- 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
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Centre National de la Recherche Scientifique, France, Institut de Physique Biologique de Strasbourg
- Responsible party
- Sponsor
- Investigators
- Anne GIERSCH, MD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350805
- Sponsor's protocol ID
- 3494
- Status last verified
- Sep 2017
- First submitted
- 10 Jul 2006
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relating the 'Experienced Present' With the Mechanisms of Neuronal Function: A Comparative Study in Patients With Schizophrenia and Healthy Controls Using Psychophysical and Neurophysiological Methods
- ClinicalTrials.gov ID
- NCT00350805
- Acronym / sponsor ID
- 3494
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Time perception, Cortical synchronization, Electroencephalography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Centre National de la Recherche Scientifique, France, Institut de Physique Biologique de Strasbourg
- Study start
- Sep 2005 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Jul 2006 (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.
Abnormalities in the ability to distinguish events in time may have a great impact on everyday life. The main objective of the study is to evaluate the magnitude of the temporal windows in schizophrenia, i.e. the time interval during which two events are perceived as synchronous. The investigators test the hypothesis that these temporal windows are enlarged, and check the relationship between this impairment and disorganization symptoms, in order to explore the link between this cognitive impairment and clinical symptoms. They explore also the neurobiological bases of the impairment by means of electroencephalogram (EEG) recordings. Event-related potentials (N50) will reveal whether or not the coding of the stimuli has the same temporal characteristics in patients and controls. The distribution and amplitude of oscillatory activities will be analyzed as a function of the synchronous or asynchronous response of the subject, thus allowing to explore the links between synchrony perception and neuronal synchronization phenomena.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Procedure: EEG |
| Patients | – | Procedure: EEG |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Primary care clinic, residents of Strasbourg
Key inclusion criteria (9 listed)
- Patients with schizophrenia (DSM-IV criteria)
- Healthy controls matched with patients on age, sex and education level
- Age between 18 and 50
- Informed consent signed
- No severe somatic illness
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EEGOne 20 minutes session | Procedure or surgery | Healthy volunteers, Patients |
Primary outcome
Not reported in the source record.
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 5 Oct 2017.
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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 GIERSCH, MD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by University Hospital, Strasbourg, France at 3 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 9 inclusion and 0 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 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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.
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 5 Oct 2017.