Autism Spectrum DisorderNCT04549506
Autism, Emotional Processing, and the Amygdala
An observational study of Autism Spectrum Disorder, run by Yawei Cheng.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 13 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 19 Apr 2014to 16 Jun 2017
- 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 13 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Autism group: 26 individuals with ASD meeting DSM-V criteria Control group: 25 gender, and age matched healthy controls
Who may be able to join
- Clinical diagnosis of severity of Autism-Spectrum Disorders
- IQ > 75
Who cannot join
- Neurological abnormalities,
- A history of epilepsy or seizures, head trauma a
- IQ <75
About this study
Official title: The Hypothesis of Emotional Empathy Imbalance in Autism: Conscious and Non-conscious Processing of Emotional Faces
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.
Keywords: Autism Spectrum Disorder; amygdala reactivity; emotional processing; fMRI
- Conditions
- Autism Spectrum Disorder
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ASD group | 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. | |
| Control group | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Age in years
Measured: 1 minutes
Anxiety scores
State-Trait Anxiety Inventory (STAI)
Measured: 10 minutes
Severity of Austism-Spectrum Disorders
Autism-Spectrum Quotient (AQ)
Measured: 20 minutes
Color identification task
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.
Measured: 10 minutes
Detection task
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.
Measured: 10 minutes
fMRI response
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start19 Apr 2014
- Primary completion21 Sep 2016
- Study completion16 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yawei Cheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yawei Cheng, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549506
- Sponsor's protocol ID
- YM102035
- Status last verified
- Sep 2020
- First submitted
- 20 Sep 2017
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15072682Williams 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.
PubMed 17854280Schumann 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.
PubMed 16855095Eimer 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.
PubMed 19330049Hall 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.
PubMed 20520836
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hypothesis of Emotional Empathy Imbalance in Autism: Conscious and Non-conscious Processing of Emotional Faces
- ClinicalTrials.gov ID
- NCT04549506
- Acronym / sponsor ID
- YM102035
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Yawei ChengUniversity, hospital or other
- Study start
- 19 Apr 2014 (actual)
- Primary completion
- 21 Sep 2016 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 16 Sep 2020 (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.
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.
Keywords: Autism Spectrum Disorder; amygdala reactivity; emotional processing; fMRI
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD group | – | –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. |
| Control group | – | –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. |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Autism group: 26 individuals with ASD meeting DSM-V criteria Control group: 25 gender, and age matched healthy controls
Key inclusion criteria (2 listed)
- Clinical diagnosis of severity of Autism-Spectrum Disorders
- IQ > 75
Key exclusion criteria (3 listed)
- Neurological abnormalities,
- A history of epilepsy or seizures, head trauma a
- IQ <75
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age
Time frame: 1 minutes
Age in years
Anxiety scores
Time frame: 10 minutes
State-Trait Anxiety Inventory (STAI)
Severity of Austism-Spectrum Disorders
Time frame: 20 minutes
Autism-Spectrum Quotient (AQ)
Color identification task
Time frame: 10 minutes
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.
Detection task
Time frame: 10 minutes
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.
fMRI response
Time frame: 10 minutes
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.
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 16 Sep 2020.
- Background: PubMed 15072682Liddell 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.
- Background: PubMed 17854280Williams 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.
- Background: PubMed 16855095Schumann 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.
- Background: PubMed 19330049Eimer 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.
- Background: PubMed 20520836Hall 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.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
Recruiting
Word Learning From Parentese in Autistic Children
Autism, Autism Spectrum Disorder
Recruiting
COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD
Autism, Autism Spectrum Disorder
Recruiting
Impact of an E-Learning Coaching for Parents of Young Children With Autism
Autism Spectrum Disorder
Not yet recruiting
Evaluation of a Novel Quantum-Inspired Intervention (QII) for Children With Autism Spectrum Disorder: A Global Confirmatory Study
Autism Spectrum Disorder, Autism Spectrum Disorder (ASD
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Yawei Cheng.
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 2 inclusion and 3 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Age (time frame: 1 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04549506, which also lists 5 linked publications.
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 16 Sep 2020.