Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-31 @ 6:40 PM
Study NCT ID:
NCT04549506
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2017-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autism, Emotional Processing, and the Amygdala
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-09', 'studyFirstSubmitDate': '2017-09-20', 'studyFirstSubmitQcDate': '2020-09-09', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age', 'timeFrame': '1 minutes', 'description': 'Age in years'}, {'measure': 'Anxiety scores', 'timeFrame': '10 minutes', 'description': 'State-Trait Anxiety Inventory (STAI)'}, {'measure': 'Severity of Austism-Spectrum Disorders', 'timeFrame': '20 minutes', 'description': 'Autism-Spectrum Quotient (AQ)'}, {'measure': 'Color identification task', 'timeFrame': '10 minutes', 'description': 'During fMRI scanning, subjects watched emotional faces and performed the color identification task, in which they were asked to judge the color of each face (pseudo-colored in either red, yellow, or blue) and to indicate the answer by a keypad button press.'}, {'measure': 'Detection task', 'timeFrame': '10 minutes', 'description': 'Immediately after fMRI scanning, participants underwent the detection task, during which they were shown all of the stimuli again and alerted of the presence of fearful faces. The subjects were administered a forced-choice test under the same presentation conditions as those during scanning and asked to indicate whether they observed a fearful face or not.'}, {'measure': 'fMRI response', 'timeFrame': '10 minutes', 'description': 'During fMRI scanning, subjects watched emotional faces and performed the color identification task, in which they were asked to judge the color of each face (pseudo-colored in either red, yellow, or blue) and to indicate the answer by a keypad button press.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'pmid': '15072682', 'type': 'BACKGROUND', 'citation': 'Liddell BJ, Williams LM, Rathjen J, Shevrin H, Gordon E. A temporal dissociation of subliminal versus supraliminal fear perception: an event-related potential study. J Cogn Neurosci. 2004 Apr;16(3):479-86. doi: 10.1162/089892904322926809.'}, {'pmid': '17854280', 'type': 'BACKGROUND', 'citation': 'Williams LM, Kemp AH, Felmingham K, Liddell BJ, Palmer DM, Bryant RA. Neural biases to covert and overt signals of fear: dissociation by trait anxiety and depression. J Cogn Neurosci. 2007 Oct;19(10):1595-608. doi: 10.1162/jocn.2007.19.10.1595.'}, {'pmid': '16855095', 'type': 'BACKGROUND', 'citation': 'Schumann CM, Amaral DG. Stereological analysis of amygdala neuron number in autism. J Neurosci. 2006 Jul 19;26(29):7674-9. doi: 10.1523/JNEUROSCI.1285-06.2006.'}, {'pmid': '19330049', 'type': 'BACKGROUND', 'citation': 'Eimer M, Kiss M, Holmes A. Links between rapid ERP responses to fearful faces and conscious awareness. J Neuropsychol. 2008 Mar;2(Pt 1):165-81. doi: 10.1348/174866407X245411.'}, {'pmid': '20520836', 'type': 'BACKGROUND', 'citation': 'Hall GB, Doyle KA, Goldberg J, West D, Szatmari P. Amygdala engagement in response to subthreshold presentations of anxious face stimuli in adults with autism spectrum disorders: preliminary insights. PLoS One. 2010 May 25;5(5):e10804. doi: 10.1371/journal.pone.0010804.'}]}, 'descriptionModule': {'briefSummary': 'Empathy imbalance hypothesis suggests that individuals with autism Spectrum Disorder (ASD) should have a deficit of cognitive empathy and a surfeit of emotional empathy. Considering that inconsistent amygdala reactivity to emotional faces might be ascribed to aberrant attention in ASD, the investigators hypothesized to investigate if there would be an imbalance between conscious and nonconscious emotional processing. This fMRI study recruited 26 youths and young adults with autism spectrum disorder and 25 matched controls, and measured their amygdala reactivity and functional connectivity in response to conscious and nonconscious (backward masked) perception of threatening faces.\n\nKeywords: Autism Spectrum Disorder; amygdala reactivity; emotional processing; fMRI'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Autism group: 26 individuals with ASD meeting DSM-V criteria Control group: 25 gender, and age matched healthy controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of severity of Autism-Spectrum Disorders\n* IQ \\> 75\n\nExclusion Criteria:\n\n* Neurological abnormalities,\n* A history of epilepsy or seizures, head trauma a\n* IQ \\<75'}, 'identificationModule': {'nctId': 'NCT04549506', 'briefTitle': 'Autism, Emotional Processing, and the Amygdala', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': 'The Hypothesis of Emotional Empathy Imbalance in Autism: Conscious and Non-conscious Processing of Emotional Faces', 'orgStudyIdInfo': {'id': 'YM102035'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ASD group', 'description': "There is no intervention to be administered in this study. Here, this fMRI study used the backwardly masked paradigm to elucidate how perceiving emotional expressions affects amygdala engagement and its related functional connectivity across two participant groups: ASD with and controls. All ASD participants were diagnosed using the Diagnostic and Statistical Manual of Mental Disorders 5th Edition's (DSM-5) diagnostic criteria (APA, 2013) and confirmed by clinical consensus. ASD individuals were recruited from a community autism program and referred to children's health doctors and child psychiatrists. Exclusion criteria for all participants were neurological abnormalities, a history of epilepsy or seizures, head trauma and IQ \\<75. The subjects did not participate in any intervention or drug programs during the experimental period."}, {'label': 'Control group', 'description': 'There is no intervention to be administered in this study. Here, this fMRI study used the backwardly masked paradigm to elucidate how perceiving emotional expressions affects amygdala engagement and its related functional connectivity across two participant groups: ASD with and controls. The participants in the age- and sex-matched control group were recruited from the local community, and screened for major psychiatric illnesses by conducting structured interviews.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yawei Cheng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yawei Cheng', 'investigatorAffiliation': 'National Yang Ming Chiao Tung University'}}}}