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CompletedNCT03376373Updated Sep 16, 2020

Neurotherapy to Promote Emotion Recognition in Autism

An interventional study of neurofeedback in Autism Spectrum Disorder, sponsored by Virginia Polytechnic Institute and State University. Completed at 1 site in United States. Open to male participants aged 16 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
16 Years to 29 Years
Sex
Male
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Autism Spectrum Disorder
03

Who can participate

Ages eligible
16 Years to 29 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • diagnosis of ASD

Exclusion criteria

Exclusion Criteria:

  • No severe psychopathology which warrants other immediate treatment
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    active

    Neurofeedback for FER

    Behavioral: neurofeedback

  • No intervention
    control

    waiting list

Interventions

  • Behavioralneurofeedback

    real-time feedback on accuracy of emotion recognition

05

What researchers measure

Primary outcomes

  1. facial emotion recognition (RMET)

    Change in facial emotion recognition 5 weeks after baseline appointment

    Time frame: 5 weeks

06

Study locations

1 site
  • Child Study Center
    Blacksburg, Virginia, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03376373
Lead sponsor
Virginia Polytechnic Institute and State University
Responsible party
John Richey (Associate Professor, Virginia Polytechnic Institute and State University) — Principal investigator
First posted
Dec 18, 2017
Start date
Sep 1, 2016
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Sep 16, 2020

Study contacts

Richey
principal investigator · Virginia Polytechnic Institute and State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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