N/A
Completed N=15
Rt-fMRI NF Intervention Study in ASD
Source: ClinicalTrials.gov NCT02440451 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: FEEST - Facial Expression of Emotion: Stimuli and Tests — 100.27; 100.79 units on a scale
Summary
This study aims to demonstrate that fMRI neurofeedback training improves the identification and comprehension of emotional facial expressions (and overall social behaviour) in subjects with ASD.
The intervention setup provides structured presentation of emotional facial expressions and the associated tools for mental imagery. The investigators hypothesize that the accomplishment of the proposed competence training improves the subjects ability to comprehend facial expressions, identify emotions and be able to correctly express them.
Intervention Type is a Device (brain computer interface using brain imaging signals) and the specific Intervention Name is Neurofeedback.
Structure: (1) initial eligibility screening, (2) pre-intervention (first week of study, baseline outcome measures and additional evaluations), (3) intervention process (8 weeks), (4) post-intervention (outcome measures and additional evaluations), and (5) follow-up (outcome measures at 6 months).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FEEST - Facial Expression of Emotion: Stimuli and Tests |
100.27; 100.79 | — |
| SECONDARY ATEC - Autism Treatment Evaluation Checklist |
32; 19.64 | — |
| SECONDARY VABS - Vineland Adaptive Behaviour Scale |
74.87; 76.93; 66.73; 67.13; 79.79; 83.14 | — |
Eligibility Criteria
Inclusion Criteria
- Positive diagnostic results for ASD in:
Autism Diagnostic Interview-Revised; Autism Diagnostic Observation Schedule; The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
Exclusion Criteria
- Global Intelligence Quotient < 80
- Associated medical condition such as epilepsy, neurocutaneous or other genetic syndromes, or other usual comorbidity in ASD samples
Data sourced from ClinicalTrials.gov (NCT02440451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.