Brain MarkersMARQUEURSNCT05635812
Brain and Eye Markers of Facial Expression Recognition and Disorders Associated with Autistic Symptoms
An observational study of Brain Markers, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
In everyday life, it is necessary to adjust one's behavior and reactions in order to interact and communicate with others in an appropriate manner. This adaptation is done by taking into account the emotions of the people with whom we interact. Read more about this study
- Who is it for?
- Ages 7 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Markers
- What is being tested?
- Neuropsychological assessment, EEG experimentation and Oculometry experimentation
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2023to Jul 2026
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: ASD, 22q11.2 and neurotypical participants
Who may be able to join
- Person, and if necessary his or her legal representative, who has given his or her non-objection
- Person whose mother tongue is French.
- Person aged between 7 and 50 years old.
- Person diagnosed with ASD according to DSM-5 criteria, person with a genetic syndrome diagnosed by FISH or CGH array (22q11 deletion), person with typical development matched in age and gender.
- Psychotropic treatment unchanged for one month and stable symptomatology.
Who cannot join
- Recent addiction according to DSM-5 criteria, excluding tobacco.
- Pregnant women.
- Uncorrected visual acuity disorder.
- Use of somatic or psychic medication that may alter brain/psychic functioning (e.g. corticosteroids).
- Neurological disorder of vascular/infectious or neurodegenerative origin.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourogne
Dijon, 21000
Jean-Michel PINOIT, 03 80 29 34 60, jean-michel.pinoit@chu-dijon.fr
About this study
In everyday life, it is necessary to adjust one's behavior and reactions in order to interact and communicate with others in an appropriate manner. This adaptation is done by taking into account the emotions of the people with whom we interact. This reading of emotions is done by using visible clues on the face, in particular by observing the eye area of the interlocutor.
The aim of the study is to investigate how processes such as attention or memory influence emotion recognition, as well as (i) their alteration in the disease, and (ii) their link with the emergence of autistic and/or psychotic symptoms. We also want to study the implementation of compensatory strategies (used to compensate for difficulties in recognizing or perceiving emotions) and the link between the correct use of these strategies and the emergence of autistic and/or psychotic symptoms.
Read more
The present project plans to include a total of 120 participants: 30 participants with ASD, 30 patients with a particular genetic deletion 22q11.2 and 60 control participants.
After the inclusion visit, participation in the study will be divided into two half-days in order to perform a neuropsychological assessment, an EEG study and an oculometry study.
- Conditions
- Brain Markers
- Being tested
- Neuropsychological assessment, EEG experimentation, Oculometry experimentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessmentOther
neuropsychological assessment and clinical scales duration: 3 hours
EEG experimentationOther
duration: 1 hour
Oculometry experimentationOther
duration: 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Participants Autism Spectrum Disorders (ASD) | ASD according to DSM-5 criteria Receives: Other: Neuropsychological assessment; Other: EEG experimentation; Other: Oculometry experimentation | |
| Participants 22q11.2 | Participants with a genetic syndrome diagnosed by FISH or CGH-array Receives: Other: Neuropsychological assessment; Other: EEG experimentation; Other: Oculometry experimentation | |
| Neurotypical participants | Neurotypical development Receives: Other: Neuropsychological assessment; Other: EEG experimentation; Other: Oculometry experimentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical brain activity in response to visual stimulation measured by electroencephalography
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start6 Jul 2023
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MarkersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635812
- Sponsor's protocol ID
- PINOIT 2022
- Acronym
- MARQUEURS
- Status last verified
- Oct 2024
- First submitted
- 23 Nov 2022
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain and Eye Markers of Facial Expression Recognition and Disorders Associated with Autistic Symptoms
- ClinicalTrials.gov ID
- NCT05635812
- Acronym / sponsor ID
- MARQUEURS / PINOIT 2022
- Conditions
- Brain Markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 2 Dec 2022 (actual)
- 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 everyday life, it is necessary to adjust one's behavior and reactions in order to interact and communicate with others in an appropriate manner. This adaptation is done by taking into account the emotions of the people with whom we interact. This reading of emotions is done by using visible clues on the face, in particular by observing the eye area of the interlocutor.
The aim of the study is to investigate how processes such as attention or memory influence emotion recognition, as well as (i) their alteration in the disease, and (ii) their link with the emergence of autistic and/or psychotic symptoms. We also want to study the implementation of compensatory strategies (used to compensate for difficulties in recognizing or perceiving emotions) and the link between the correct use of these strategies and the emergence of autistic and/or psychotic symptoms.
The present project plans to include a total of 120 participants: 30 participants with ASD, 30 patients with a particular genetic deletion 22q11.2 and 60 control participants.
After the inclusion visit, participation in the study will be divided into two half-days in order to perform a neuropsychological assessment, an EEG study and an oculometry study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants Autism Spectrum Disorders (ASD) | – | Other: Neuropsychological assessment, Other: EEG experimentation, Other: Oculometry experimentationASD according to DSM-5 criteria |
| Participants 22q11.2 | – | Other: Neuropsychological assessment, Other: EEG experimentation, Other: Oculometry experimentationParticipants with a genetic syndrome diagnosed by FISH or CGH-array |
| Neurotypical participants | – | Other: Neuropsychological assessment, Other: EEG experimentation, Other: Oculometry experimentationNeurotypical development |
Who may qualify
- Ages
- 7 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- ASD, 22q11.2 and neurotypical participants
Key inclusion criteria (5 listed)
- Person, and if necessary his or her legal representative, who has given his or her non-objection
- Person whose mother tongue is French.
- Person aged between 7 and 50 years old.
- Person diagnosed with ASD according to DSM-5 criteria, person with a genetic syndrome diagnosed by FISH or CGH array (22q11 deletion), person with typical development matched in age and gender.
- Psychotropic treatment unchanged for one month and stable symptomatology.
Key exclusion criteria (5 listed)
- Recent addiction according to DSM-5 criteria, excluding tobacco.
- Pregnant women.
- Uncorrected visual acuity disorder.
- Use of somatic or psychic medication that may alter brain/psychic functioning (e.g. corticosteroids).
- Neurological disorder of vascular/infectious or neurodegenerative origin.
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 assessmentneuropsychological assessment and clinical scales duration: 3 hours | Other | Neurotypical participants, Participants 22q11.2, Participants Autism Spectrum Disorders (ASD) |
| EEG experimentationduration: 1 hour | Other | Neurotypical participants, Participants 22q11.2, Participants Autism Spectrum Disorders (ASD) |
| Oculometry experimentationduration: 30 minutes | Other | Neurotypical participants, Participants 22q11.2, Participants Autism Spectrum Disorders (ASD) |
Primary outcome
Electrical brain activity in response to visual stimulation measured by electroencephalography
Time frame: at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Markers, run by Centre Hospitalier Universitaire Dijon 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 5 inclusion and 5 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 4 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Michel PINOIT (03 80 29 34 60, jean-michel.pinoit@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrical brain activity in response to visual stimulation measured by electroencephalography (time frame: at baseline). 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 4 Oct 2024.