Flexibility and the Predictive Brain in Autistic Males and Females
ConditionAutism Spectrum Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorUniversity Hospital, Grenoble
About this trial
The goal of this study is to compare the neural correlates of predictive brain mechanisms during high-level social and non-social flexibility tasks, between autistic and non-autistic males and females. The aim is to better understand if autistic individuals differ from non-autistic individuals in their cognitive flexibility according to the social and predictable nature of the stimuli, at a behavioral and neurofunctional level using the functional Magnetic Resonance Imaging (fMRI). As autistic females usually present a more subtle profile than autistic males, the investigators will also explore if autistic males and females present neurofunctional differences.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Affiliation with social security scheme.
Registration in the national database of individuals willing to participate in research involving human subjects.
Absence of contraindications for MRI.
Signed informed consent before any study-related procedure.
Disqualifiers
Any subject with a vascular stent implanted less than 6 weeks before the examination.
Any subject with implanted biomedical material deemed "unsafe" or "not safe" in the list: http://www.mrisafety.com/TheList_search.asp.
Any acquisition procedure not meeting the conditions required for "conditional" use in subjects with implanted biomedical material classified as "conditional" in the list: http://www.mrisafety.com/TheList_search.asp.
Any subject with biomedical material such as a cardiac, neuronal, or sensory stimulator (cochlear implant due to the risk of demagnetization, heating, electrode, and artifacts) or a ventricular shunt valve without medical and paramedical supervision trained in MRI performance in these subjects.
Trial population
Autistic with a diagnosis and non autistic adults.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Social/non social; predictable vs unpredictable
BehavioralTask 1: social predictable vs social unpredictable ; Task2 a. social \& b. non social, predictable/unpredictable (for both)
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Autistic adults1 intervention
Group B: Non autistic adults1 intervention
Trial outcomes
Primary outcomes
1
Neurofunctional activity specificity of autistic adults in predictive processes during cognitive flexibility tasks
fMRI BOLD signal
Time frame
during activation tasksSecondary outcomes
1
Functional connectivity specificity of autistic adults
BOLD-fMRI signal during resting state (BOLD-RS)
Time frame
through study completion, an average of 1 year2
EST accuracy
the emotional shifting task (EST), is one of the task that will be performed in the fMRI. During this task participants evaluate the valence of emotion (positive vs. negative) on an image while it's truncated; then, the image appears not truncated, and the participant must reevaluate its valence. In some cases, the valence has changed (from positive to negative or from negative to positive), and the participant must consider scene cues and demonstrate flexibility to reassess their judgment. We will collect the accuracy of this task
Time frame
through study completion, an average of 1 year3
EST response time
We will collect the response time in this task (described above)
Time frame
through study completion, an average of 1 year4
TST accuracy
The Task-Switching Task (TST) is described in the study description. We will collect the accuracy of this task
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Grenoble
Lead sponsor
Laboratoire de Psychologie et NeuroCognition
Collaborator
Source ClinicalTrials.gov