跳至主要内容
临床试验/NCT02440451
NCT02440451已完成不适用

Improving Facial Expression Identification in ASD: a Real-time fMRI Neurofeedback Approach

University of Coimbra0 个研究点目标入组 15 人开始时间: 2016年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
主要终点
FEEST - Facial Expression of Emotion: Stimuli and Tests

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Neurofeedback using BCI

Experimental

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

干预措施: Neurofeedback using BCI (Device)

结局指标

主要结局

FEEST - Facial Expression of Emotion: Stimuli and Tests

时间窗: 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.

次要结局

  • VABS - Vineland Adaptive Behaviour Scale(8 weeks (Endpoint 1) plus 6 months follow-up)
  • ATEC - Autism Treatment Evaluation Checklist(8 weeks (Endpoint 1) plus 6 months follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Miguel Castelo-Branco

MD, PhD

University of Coimbra

相似试验