NCT04549506

Brief 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 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2017

Completed
3 years until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

2.4 years

First QC Date

September 20, 2017

Last Update Submit

September 9, 2020

Conditions

Outcome Measures

Primary Outcomes (6)

  • Age

    Age in years

    1 minutes

  • Anxiety scores

    State-Trait Anxiety Inventory (STAI)

    10 minutes

  • Severity of Austism-Spectrum Disorders

    Autism-Spectrum Quotient (AQ)

    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.

    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.

    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.

    10 minutes

Study Arms (2)

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.

Eligibility Criteria

Age13 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Autism group: 26 individuals with ASD meeting DSM-V criteria Control group: 25 gender, and age matched healthy controls

You may qualify if:

  • Clinical diagnosis of severity of Autism-Spectrum Disorders
  • IQ \> 75

You may not qualify if:

  • Neurological abnormalities,
  • A history of epilepsy or seizures, head trauma a
  • IQ \<75

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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: 15072682BACKGROUND
  • 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: 17854280BACKGROUND
  • 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: 16855095BACKGROUND
  • 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: 19330049BACKGROUND
  • 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.

    PMID: 20520836BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 16, 2020

Study Start

April 19, 2014

Primary Completion

September 21, 2016

Study Completion

June 16, 2017

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share