Neurotherapy to Promote Emotion Recognition in Autism
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
neurofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- diagnosis of ASD
Exclusion Criteria:
- No severe psychopathology which warrants other immediate treatment
Sites / Locations
- Child Study Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
active
control
Arm Description
Neurofeedback for FER
waiting list
Outcomes
Primary Outcome Measures
facial emotion recognition (RMET)
Change in facial emotion recognition 5 weeks after baseline appointment
Secondary Outcome Measures
Full Information
NCT ID
NCT03376373
First Posted
December 18, 2016
Last Updated
September 12, 2020
Sponsor
Virginia Polytechnic Institute and State University
1. Study Identification
Unique Protocol Identification Number
NCT03376373
Brief Title
Neurotherapy to Promote Emotion Recognition in Autism
Official Title
Neurotherapy to Promote Emotion Recognition in Autism
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
independent evaluators are masked to condition assignment
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active
Arm Type
Experimental
Arm Description
Neurofeedback for FER
Arm Title
control
Arm Type
No Intervention
Arm Description
waiting list
Intervention Type
Behavioral
Intervention Name(s)
neurofeedback
Intervention Description
real-time feedback on accuracy of emotion recognition
Primary Outcome Measure Information:
Title
facial emotion recognition (RMET)
Description
Change in facial emotion recognition 5 weeks after baseline appointment
Time Frame
5 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
diagnosis of ASD
Exclusion Criteria:
No severe psychopathology which warrants other immediate treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richey
Organizational Affiliation
Virginia Polytechnic Institute and State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child Study Center
City
Blacksburg
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neurotherapy to Promote Emotion Recognition in Autism
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