Neurotherapy to Promote Emotion Recognition in Autism

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder, more prevalent than previously thought and heterogeneous in expression, though uniformly characterized by severe social disability. The social disability that defines ASD pervades other areas of adaptive behavior, is predictive of secondary mental health problems, and adversely affects long-term outcome. Although ASD is a chronic condition, there has been little research on interventions for adults with ASD. This study proposes to first establish the neural plasticity of specific brain mechanisms underlying difficulties with facial emotion recognition, a core deficit believed to be pivotal in the behavioral expression of ASD-social disability. The investigators will then develop a novel, computer-based intervention using real-time feedback, to the user, to ameliorate emotion recognition deficits.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: neurofeedback

Detailed Description

Individuals with autism spectrum disorder (ASD) are known to have difficulty in the recognition of facial emotion. Such deficits in facial emotion recognition (FER) are thought to cause or exacerbate social disability in ASD by preventing 1) accurate detection of social/emotional information conveyed through the face and, subsequently 2) the deployment of emotionally appropriate responses. Consistent with this model, FER deficits are correlated with social disability in ASD and confer morbidity above and beyond core symptoms.

The long-term goal is to understand how FER networks can be manipulated for therapeutic and preventative purposes. In this trial, investigators are testing the feasibility of an intervention that capitalizes on our previously developed brain-computer interface (BCI) to promote FER in a mixed virtual reality world. The new "FER Assistant" tool (deployed on a tablet - iPad) is intended to aid users in detecting emotions and intents of 'avatars' inhabiting a virtual world, and will provide users with a highly realistic testbed for practicing FER skills in concert with BCI.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Blacksburg, Virginia, United States
      • Child Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 29 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• diagnosis of ASD

Exclusion Criteria:

• No severe psychopathology which warrants other immediate treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active; Neurofeedback for FER	Behavioral: neurofeedback; real-time feedback on accuracy of emotion recognition
No Intervention: control; waiting list

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
facial emotion recognition (RMET)	Change in facial emotion recognition 5 weeks after baseline appointment	5 weeks

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University
• Investigators: Principal Investigator: Richey, Virginia Polytechnic Institute and State University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: December 18, 2016
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 12, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: MH100268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO