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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 12, 2018
Last Update Posted : November 12, 2018
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 (BCI using neuroimaging) 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.


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 (BCI using neuroimaging)
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 ]
    The Emotion Hexagon test will be the primary outcome measure. Both groups will be evaluated in the pre and post evaluation time with this test. 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 plus 6 months follow up ]
    77-items: speech/language/communication (14 items); sociability (20 items); sensory/cognitive awareness (18 items); health/physical/behaviour (25 items)

  2. VABS - Vineland Adaptive Behaviour Scale [ Time Frame: 8 weeks plus 6 months follow up ]
    297 items measure of adaptive behaviour Three main domains: Communication (COM), Daily Living Skills (DLS) and Socialization (SOC) and total score, the Adaptive Behaviour Composite (ABC)


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

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

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



Information from the National Library of Medicine

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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
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:
Responsible Party: Miguel Castelo-Branco, MD, PhD, University of Coimbra
ClinicalTrials.gov Identifier: NCT02440451     History of Changes
Other Study ID Numbers: IBILI-VB-2015-02
First Posted: May 12, 2015    Key Record Dates
Results First Posted: November 12, 2018
Last Update Posted: November 12, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders