Rt-fMRI NF Intervention Study in ASD

NCT02440451 | Completed Results

• 1 other identifier: IBILI-VB-2015-02
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• FEEST - Facial Expression of Emotion: Stimuli and Tests

  The Emotion Hexagon test represents the primary outcome measure. The assessment based on this test will be performed before (baseline), after the intervention - endpoint 1 (at 8 weeks) and at the 6 months follow-up. The Emotion Hexagon test uses stimuli of graded difficulty, created using computer image manipulation techniques (morphing is used to modify photographs from the Ekman and Friesen (1976) series, creating examples that lie close to or more distant from the prototype expression). The 120 test trials with unambiguous stimuli (4 pictures for each of the 6 emotions across the 5 test blocks) can be used to derive an overall (total) score out of a possible maximum of 120 expressions correctly recognized.

  8 weeks (Endpoint 1) plus 6 months follow-up

Secondary Outcomes (2)

• ATEC - Autism Treatment Evaluation Checklist

  8 weeks (Endpoint 1) plus 6 months follow up

• VABS - Vineland Adaptive Behaviour Scale

  8 weeks (Endpoint 1) plus 6 months follow-up

Other Outcomes (4)

• POMS - Profile of Mood States

  8 weeks (Endpoint 1) plus 6 months follow-up

• HADS - Hospital Anxiety & Depression Scale

  8 weeks (Endpoint 1) plus 6 months follow-up

• BDI - Beck Depression Inventory

  8 weeks (Endpoint 1) plus 6 months follow-up

Study Arms (1)

Neurofeedback using BCI

EXPERIMENTAL

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

Device: Neurofeedback using BCI

Interventions

Neurofeedback using BCI 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.

Neurofeedback using BCI

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Global Intelligence Quotient \< 80
• Associated medical condition such as epilepsy, neurocutaneous or other genetic syndromes, or other usual comorbidity in ASD samples

Sponsors & Collaborators

• University of Coimbra: lead

Related Publications (2)

• 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.

  PMID: 11280420 BACKGROUND

• 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.

  PMID: 10827445 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Prof. Dr. Miguel Castelo-Branco
• Organization: University of Coimbra

mcbranco@fmed.uc.pt

+351239790000

Study Officials

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

  IBILI - Institute for Biomedical Imaging in Life Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: May 12, 2015
• Study Start: February 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: February 20, 2019
• Results First Posted: November 13, 2018

Record last verified: 2018-11