Rt-fMRI NF Intervention Study in ASD

NCT ID: NCT02440451

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-09-30

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neurofeedback using BCI

16 (13 + 3 in case of dropoffs) ASD subjects

Group Type: EXPERIMENTAL

Neurofeedback using BCI

Intervention Type: DEVICE

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.

Interventions

Neurofeedback using BCI

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 Type: DEVICE

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Miguel Castelo-Branco

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miguel S Castelo-Branco, M. D., PhD.

Role: PRINCIPAL_INVESTIGATOR

IBILI - Institute for Biomedical Imaging in Life Sciences

References

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.

Reference Type: BACKGROUND

PMID: 11280420 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10827445 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

IBILI-VB-2015-02

Identifier Type: -

Identifier Source: org_study_id