Clinical trial NCT02440451: Rt-fMRI NF Intervention Study in ASD
Official title: Improving Facial Expression Identification in ASD: a Real-time fMRI Neurofeedback Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed description: Clinical research has demonstrated that ASD children have deficits in the identification and interpretation of the emotional and mental state of others (Baron-Cohen 2001). An important skill to this end (impaired in ASD patients), is to appropriately recognize and discriminate emotional expressions.

The main brain regions involved in face processing the inferior occipital gyri, lateral portion of the fusiform gyrus (especially a region deemed the fusiform face area or FFA), and posterior superior temporal sulcus (pSTS) (Haxby et al. 2000). STS plays a key role on several basic aspects in social information processing, and deficits in ASD have been found associated to this region.

The purpose of the study is to determine the effect of neurofeedback considering a social cognition brain region (i.e. pSTS) on the identification of facial expressions in ASD patients. The intervention comprehends seven BCI sessions spread over four months. The first four sessions are weekly, and the rest monthly. In each session, the subjects are asked to imagine different facial expressions and their brain activity (i.e. BOLD activation in the pSTS region) is interpreted and used to estimate a feedback signal.The hypothesis is that the training induced up-regulation of the target region, improves clinical symptoms.

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

Primary outcomes:
measure: FEEST - Facial Expression of Emotion: Stimuli and Tests
timeFrame: 8 weeks (Endpoint 1) plus 6 months follow-up
Secondary outcomes:
measure: ATEC - Autism Treatment Evaluation Checklist
timeFrame: 8 weeks (Endpoint 1) plus 6 months follow up
measure: VABS - Vineland Adaptive Behaviour Scale
timeFrame: 8 weeks (Endpoint 1) plus 6 months follow-up
Other outcomes:
measure: POMS - Profile of Mood States
timeFrame: 8 weeks (Endpoint 1) plus 6 months follow-up
measure: HADS - Hospital Anxiety & Depression Scale
timeFrame: 8 weeks (Endpoint 1) plus 6 months follow-up
measure: BDI - Beck Depression Inventory
timeFrame: 8 weeks (Endpoint 1) plus 6 months follow-up
measure: Debriefing Interview Questionnaire
timeFrame: 8 weeks (Endpoint 1)
Locations:
Study officials:
affiliation: IBILI - Institute for Biomedical Imaging in Life Sciences
name: Miguel S Castelo-Branco, M. D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baron-Cohen S, Wheelwright S, Hill J, Raste Y, Plumb I. The "Reading the Mind in the Eyes" Test revised version: a study with normal adults, and adults with Asperger syndrome or high-functioning autism. J Child Psychol Psychiatry. 2001 Feb;42(2):241-51.
citation: Haxby JV, Hoffman EA, Gobbini MI. The distributed human neural system for face perception. Trends Cogn Sci. 2000 Jun;4(6):223-233. doi: 10.1016/s1364-6613(00)01482-0.