Autism Spectrum DisorderNCT03376373
Neurotherapy to Promote Emotion Recognition in Autism
A study testing neurofeedback in people with Autism Spectrum Disorder, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 29 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- diagnosis of ASD
Who cannot join
- No severe psychopathology which warrants other immediate treatment
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- neurofeedback
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurofeedbackBehavioural
real-time feedback on accuracy of emotion recognition
| Study group | Role | What they receive |
|---|---|---|
| active | Experimental | Neurofeedback for FER Receives: Behavioral: neurofeedback |
| control | No intervention | waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
facial emotion recognition (RMET)
Change in facial emotion recognition 5 weeks after baseline appointment
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start1 Sep 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Richey, Virginia Polytechnic Institute and State University
- Investigators
- Richey, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376373
- Sponsor's protocol ID
- MH100268
- Status last verified
- Sep 2020
- First submitted
- 18 Dec 2016
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurotherapy to Promote Emotion Recognition in Autism
- ClinicalTrials.gov ID
- NCT03376373
- Acronym / sponsor ID
- MH100268
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active | Experimental | Behavioral: neurofeedbackNeurofeedback for FER |
| control | No intervention | –waiting list |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- diagnosis of ASD
Key exclusion criteria (1 listed)
- No severe psychopathology which warrants other immediate treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurofeedbackreal-time feedback on accuracy of emotion recognition | Behavioural | active |
Primary outcome
facial emotion recognition (RMET)
Time frame: 5 weeks
Change in facial emotion recognition 5 weeks after baseline appointment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richey principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurofeedback in people with Autism Spectrum Disorder, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
facial emotion recognition (RMET) (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.