Autism Spectrum DisorderRESYSTAANCT05391113
REward SYSTem in Autism Spectrum Disorder and Addictive Disorder
A study testing MRI and EEG in people with Autism Spectrum Disorder, run by University Hospital, Tours at 3 sites in France.
Trial summary
An MRI Study in Subjects with Autism Spectrum Disorder and Subjects with Food Addictive Disorder compared to healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- MRI and EEG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 3 sitesFrance
- Study dates
- 27 Jul 2023to 27 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Arm A ˗ Concerning ASD patients: Adult carrying the diagnosis of ASD (DSM-5, ADOS, ADI-R criteria)
- Arm B ˗ Concerning FAD patients: Adult diagnosed with FA presenting with food addiction (DSM-5, YFAS 2.0, BES >= 18 criteria).
- Arm C ˗ Concerning healthy volunteers : Adult with no neurological and psychiatric history , absence of progressive somatic pathologies or with vital risk.
- For all participants:
- Age greater than or equal to 18 years old
- Without intellectual delay (IQ > 70).
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- Able to understand and apply the instruction when an active task is proposed, according to the estimate of the investigator.
- Free, express, informed and written consent of the participant.
- Participant affiliated to a social security scheme
Who cannot join
- Neuromotor disorders.
- Visual disturbances not corrected or incompatible with MRI.
- Known epilepsy.
- Current substance use disorder with emotional distress/significant impact on functional outcome
- Rare genetic syndrome.
- Contraindications to MRI (other than body circumference)
- For women of childbearing age: negative urine or blood pregnancy test
- Person subject to a measure of judicial protection (safeguard of justice, curatorship, guardianship or family authorization)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Center-Val de Loire Region Autism Resource Center
Tours, 37044
Emmanuelle HOUY-DURAND, MD-PhD, +3318370545, E.HOUY-DURAND@chu-tours.fr
Frédéric BRIEND, PhD
- Recruiting
University Addictology Service, Liaison Team and Addictology Care
Tours, 37044
Paul BRUNAULT, MD-PhD, +33247474747 ext. 72882, paul.brunault@univ-tours.fr
Paul BRUNAULT, MD-PhD
- Recruiting
University Hospital, Medical Imaging Service
Tours, 37044
Jean-Philippe COTTIER, MD-PhD, +33234379615, cottier@med.univ-tours.fr
Jean-Philippe COTTIER, MD-PhD
About this study
Official title: Stimuli Sociaux Et Non-sociaux Du Système De Récompense : Une Étude En IRM Chez Des Sujets Avec Trouble Du Spectre De L'autisme Et Des Sujets Avec Un Trouble Addictif À L'alimentation. - RESYSTAA
An MRI Study in Subjects with Autism Spectrum Disorder and Subjects with Food Addictive Disorder compared to healthy volunteers.
Read the detailed description
An MRI Study in Subjects with Autism Spectrum Disorder and Subjects with Food Addictive Disorder compared to healthy volunteers, where pathophysiology common to both disorders, based on a dysfunction of the reward system. The project we propose aims to explore the neural networks underlying these alterations in patients suffering from autism or addictive disorder.
- Conditions
- Autism Spectrum Disorder
- Being tested
- MRI, EEG
- Keywords
- Autism; MRI;Addictive disorders
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Also called Functionnal MRI
an fMRI measurement of the BOLD physiological signal for sensory responses
EEGDiagnostic test
Also called Electro Encephalography
These tests, through videos with a social or non-social content (human presence or absence on the stereoscopic projection), will allow us to study two types of sensorialities (visual and interoceptive). Thus, it will be possible to obtain inter- and exteroceptive profiles of the participants, a direct reflection of the processing of the internal bodily sensations of the body.
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder | Experimental | Characterized by two main diagnostic criteria: a socio-emotional deficit via a defect in communication and social reciprocity, and a behavioral deficit which manifests itself in repetitive behavioral patterns (stereotypes), restricted interests and/or activities. Receives: Diagnostic Test: MRI; Diagnostic Test: EEG |
| Food Addictive Disorders | Active comparator | Characterized by regroup substance use disorders and behavioral addictions, are characterized in particular by the repeated occurrence of compulsive behavior and impaired social functioning Receives: Diagnostic Test: MRI; Diagnostic Test: EEG |
| Healthy volonteers | Placebo comparator | Adult without neurological and psychiatric history, absence of progressive somatic pathologies or with vital risk. Receives: Diagnostic Test: MRI; Diagnostic Test: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygene Level Dependent (BOLD) MRI signal
Measurement in fMRI of the BOLD signal for each condition (interest, addiction, social) will be carried out in order to highlight the possible alterations of the reward system, in particular at the level of the striatum in terms of cerebral activation for each of the groups of subjects. (FAD, ASD and HV).
Measured: At inclusion
Secondary outcomes (2)
Tolerance to an MRI examination for FAD with overweight or obesity
For the tolerance to an MRI examination for FAD with overweight or obesity: feedback on their experience in MRI.
Measured: At inclusion
Regulation of sensory, an fMRI measurement of the BOLD physiological signal for sensory responses (sensory block) in terms of brain activation in patients
Regulation of sensory, an fMRI measurement of the BOLD physiological signal for sensory responses (sensory block) in terms of brain activation in patients with FAD compared to ASD subjects and healthy volunteers.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start27 Jul 2023
- Primary completion27 Jul 2026 (estimated)
- Study completion27 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study, monocentric open in three parallel groups (ASD, AD and healthy volunteers).
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM UMR-1253, Tours, France
- Responsible party
- Sponsor
- Investigators
- Frédéric BRIEND, PhD, Principal investigator, University Hospital,Tours -INSERM U1253 iBrain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391113
- Sponsor's protocol ID
- DR220016
- Other IDs
- 2022-A01098-35, 22-87
- Acronym
- RESYSTAA
- Status last verified
- Dec 2024
- First submitted
- 20 May 2022
- Last updated
- 6 Dec 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimuli Sociaux Et Non-sociaux Du Système De Récompense : Une Étude En IRM Chez Des Sujets Avec Trouble Du Spectre De L'autisme Et Des Sujets Avec Un Trouble Addictif À L'alimentation. - RESYSTAA
- ClinicalTrials.gov ID
- NCT05391113
- Acronym / sponsor ID
- RESYSTAA / DR220016
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism; MRI;Addictive disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- INSERM UMR-1253, Tours, France
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 27 Jul 2026 (estimated)
- Study completion
- 27 Jan 2027 (estimated)
- First posted
- 25 May 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.
An MRI Study in Subjects with Autism Spectrum Disorder and Subjects with Food Addictive Disorder compared to healthy volunteers.
Detailed description
An MRI Study in Subjects with Autism Spectrum Disorder and Subjects with Food Addictive Disorder compared to healthy volunteers, where pathophysiology common to both disorders, based on a dysfunction of the reward system. The project we propose aims to explore the neural networks underlying these alterations in patients suffering from autism or addictive disorder.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Pilot study, monocentric open in three parallel groups (ASD, AD and healthy volunteers).
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder | Experimental | Diagnostic Test: MRI, Diagnostic Test: EEGCharacterized by two main diagnostic criteria: a socio-emotional deficit via a defect in communication and social reciprocity, and a behavioral deficit which manifests itself in repetitive behavioral patterns (stereotypes), restricted interests and/or activities. |
| Food Addictive Disorders | Active comparator | Diagnostic Test: MRI, Diagnostic Test: EEGCharacterized by regroup substance use disorders and behavioral addictions, are characterized in particular by the repeated occurrence of compulsive behavior and impaired social functioning |
| Healthy volonteers | Placebo comparator | Diagnostic Test: MRI, Diagnostic Test: EEGAdult without neurological and psychiatric history, absence of progressive somatic pathologies or with vital risk. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Arm A ˗ Concerning ASD patients: Adult carrying the diagnosis of ASD (DSM-5, ADOS, ADI-R criteria)
- Arm B ˗ Concerning FAD patients: Adult diagnosed with FA presenting with food addiction (DSM-5, YFAS 2.0, BES >= 18 criteria).
- Arm C ˗ Concerning healthy volunteers : Adult with no neurological and psychiatric history , absence of progressive somatic pathologies or with vital risk.
- Age greater than or equal to 18 years old
- Without intellectual delay (IQ > 70).
Key exclusion criteria (8 listed)
- Neuromotor disorders.
- Visual disturbances not corrected or incompatible with MRI.
- Known epilepsy.
- Current substance use disorder with emotional distress/significant impact on functional outcome
- Rare genetic syndrome.
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 |
|---|---|---|
| MRIAlso: Functionnal MRIan fMRI measurement of the BOLD physiological signal for sensory responses | Diagnostic test | Autism Spectrum Disorder, Food Addictive Disorders, Healthy volonteers |
| EEGAlso: Electro EncephalographyThese tests, through videos with a social or non-social content (human presence or absence on the stereoscopic projection), will allow us to study two types of sensorialities (visual and interoceptive). Thus, it will be possible to obtain inter- and exteroceptive profiles of the participants, a direct reflection of the processing of the internal bodily sensations of the body. | Diagnostic test | Autism Spectrum Disorder, Food Addictive Disorders, Healthy volonteers |
Primary outcome
Blood Oxygene Level Dependent (BOLD) MRI signal
Time frame: At inclusion
Measurement in fMRI of the BOLD signal for each condition (interest, addiction, social) will be carried out in order to highlight the possible alterations of the reward system, in particular at the level of the striatum in terms of cerebral activation for each of the groups of subjects. (FAD, ASD and HV).
2 secondary outcomes
Tolerance to an MRI examination for FAD with overweight or obesity
Time frame: At inclusion
Regulation of sensory, an fMRI measurement of the BOLD physiological signal for sensory responses (sensory block) in terms of brain activation in patients
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 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.
Frédéric BRIEND, PhD principal investigator
University Hospital,Tours -INSERM U1253 iBrain
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and EEG in people with Autism Spectrum Disorder, run by University Hospital, Tours 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 8 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: looking for participants now, as of the sponsor's last update on 6 Dec 2024. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédéric BRIEND, PhD (+33247478519, frederic.briend@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Oxygene Level Dependent (BOLD) MRI signal (time frame: At inclusion). 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 Dec 2024.