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Trial record 1 of 1 for:    NCT02440451
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Rt-fMRI NF Intervention Study in ASD (NF-ASD)

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ClinicalTrials.gov Identifier: NCT02440451
Recruitment Status : Completed
First Posted : May 12, 2015
Results First Posted : November 13, 2018
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Miguel Castelo-Branco, University of Coimbra

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).


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Device: Neurofeedback using BCI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Facial Expression Identification in ASD: a Real-time fMRI Neurofeedback Approach
Actual Study Start Date : February 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neurofeedback using BCI
16 (13 + 3 in case of dropoffs) ASD subjects
Device: 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.




Primary Outcome Measures :
  1. FEEST - Facial Expression of Emotion: Stimuli and Tests [ Time Frame: 8 weeks (Endpoint 1) plus 6 months follow-up ]
    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.


Secondary Outcome Measures :
  1. ATEC - Autism Treatment Evaluation Checklist [ Time Frame: 8 weeks (Endpoint 1) plus 6 months follow up ]

    Autism Treatment Evaluation Checklist (ATEC) evaluates the effectiveness of autism treatments - a 1-page form designed to be completed by parents or caretakers. It consists of 4 subtests: I. Speech/Language Communication (14 items, min.0-max.28); II. Sociability (20 items, min.0-max.40); III. Sensory/Cognitive Awareness (18 items, min.0-max.36); and IV. Health/Phys./Behavior (25 items, min.0-max.75). Total score (sum) ranges from min.0-max.179.

    The results reported here correspond to the total ATEC score to be used for comparison at a later date. The lower the score, the fewer the problems.


  2. VABS - Vineland Adaptive Behaviour Scale [ Time Frame: 8 weeks (Endpoint 1) plus 6 months follow-up ]

    The Vineland Adaptive Behaviour Scale (VABS) is a semi-structured interview designed to assess global adaptive functioning, composed by 3 main domains: Communication COM, Daily Living Skills DLS and Socialization SOC (all reported here in terms of standard scores as described in the VABS manual, i.e. mean 100 and standard deviation 15).

    The Adaptive Behaviour Composite ABC (total score, also reported here) is the sum of the raw scores from the three main domains. These are transformed in standard scores (m.=100;std.=15).

    The higher the score, better is the adaptive behavior.



Other Outcome Measures:
  1. POMS - Profile of Mood States [ Time Frame: 8 weeks (Endpoint 1) plus 6 months follow-up ]
  2. HADS - Hospital Anxiety & Depression Scale [ Time Frame: 8 weeks (Endpoint 1) plus 6 months follow-up ]
    24-item scale (7 depression & 7 anxiety items)

  3. BDI - Beck Depression Inventory [ Time Frame: 8 weeks (Endpoint 1) plus 6 months follow-up ]
    21-item measure of clinical depression

  4. Debriefing Interview Questionnaire [ Time Frame: 8 weeks (Endpoint 1) ]
    Covers: strategies; general experience of the process; adverse effects;



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440451


Sponsors and Collaborators
University of Coimbra
Investigators
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Principal Investigator: Miguel S Castelo-Branco, M. D., PhD. IBILI - Institute for Biomedical Imaging in Life Sciences
  Study Documents (Full-Text)

Documents provided by Miguel Castelo-Branco, University of Coimbra:
Statistical Analysis Plan  [PDF] February 14, 2017
Study Protocol  [PDF] February 14, 2017


Publications:
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Responsible Party: Miguel Castelo-Branco, MD, PhD, University of Coimbra
ClinicalTrials.gov Identifier: NCT02440451    
Other Study ID Numbers: IBILI-VB-2015-02
First Posted: May 12, 2015    Key Record Dates
Results First Posted: November 13, 2018
Last Update Posted: February 20, 2019
Last Verified: November 2018
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders