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Neurotherapy to Promote Emotion Recognition in Autism

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ClinicalTrials.gov Identifier: NCT03376373
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Susan White, Virginia Polytechnic Institute and State University

Brief 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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: neurofeedback Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: independent evaluators are masked to condition assignment
Primary Purpose: Treatment
Official Title: Neurotherapy to Promote Emotion Recognition in Autism
Study Start Date : September 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. facial emotion recognition (RMET) [ Time Frame: 5 weeks ]
    Change in facial emotion recognition 5 weeks after baseline appointment



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diagnosis of ASD

Exclusion Criteria:

  • No severe psychopathology which warrants other immediate treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376373


Contacts
Contact: Susan White, PhD 540-231-8276 sww@vt.edu

Locations
United States, Virginia
Child Study Center Recruiting
Blacksburg, Virginia, United States
Contact: Suasn White, PhD    540-231-8276    sww@vt.edu   
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
Investigators
Principal Investigator: White Virginia Polytechnic Institute and State University

Responsible Party: Susan White, Associate Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT03376373     History of Changes
Other Study ID Numbers: MH100268
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders