Rt-fMRI NF Intervention Study in ASD
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

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.
    

Intervention name(s): Neurofeedback using BCI
Intervention type(s): Device
Intervention description(s): This group will undergo five sessions of neurofeedback intervention in the fMRI scanner. Each subject will also undergo neuropsychological evaluations before the first neurofeedback session (week 0) and after the last neurofeedback session (week 7). The first four sessions are weekly while the last one is one month later. The intervention will take a total of four months. Follow up will be performed in the the first week and 6 months after the last intervention session.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment