Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurofeedback using BCI | Experimental | 16 (13 + 3 in case of dropoffs) ASD subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ATEC - Autism Treatment Evaluation Checklist | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| POMS - Profile of Mood States | 8 weeks (Endpoint 1) plus 6 months follow-up | |
| HADS - Hospital Anxiety & Depression Scale | 24-item scale (7 depression & 7 anxiety items) | 8 weeks (Endpoint 1) plus 6 months follow-up |
Inclusion Criteria:
Autism Diagnostic Interview-Revised; Autism Diagnostic Observation Schedule; The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Miguel S Castelo-Branco, M. D., PhD. | IBILI - Institute for Biomedical Imaging in Life Sciences | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11280420 | Background | 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. | |
| 10827445 | 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. |
Not provided
Not provided
There was no significant events after participant enrollment, before group assignment.
The participants, mainly recruited on a collaborative effort between the Pediatrics Hospital of Coimbra and local ASD associations, were invited for an fMRI neurofeedback feasibility clinical trial study in ASD. All participants had normal or corrected to normal vision. ). The first participant was recruited in February 2016.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Neurofeedback Using BCI | 16 (13 + 3 in case of dropoffs) ASD subjects 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of participants is similar to the assigned in the participant flow.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Neurofeedback Using BCI | 16 (13 + 3 in case of dropoffs) ASD subjects 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks (Endpoint 1) plus 6 months follow-up |
|
6 months (from baseline until 6 months follow-up assessment)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neurofeedback Using BCI | 16 (13 + 3 in case of dropoffs) ASD subjects 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Miguel Castelo-Branco | University of Coimbra | +351239790000 | mcbranco@fmed.uc.pt |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 14, 2017 | Oct 10, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 14, 2017 | Oct 10, 2018 | Prot_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 8 weeks (Endpoint 1) plus 6 months follow up |
| VABS - Vineland Adaptive Behaviour Scale | 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. | 8 weeks (Endpoint 1) plus 6 months follow-up |
| BDI - Beck Depression Inventory | 21-item measure of clinical depression | 8 weeks (Endpoint 1) plus 6 months follow-up |
| Debriefing Interview Questionnaire | Covers: strategies; general experience of the process; adverse effects; | 8 weeks (Endpoint 1) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| FEEST - Facial Expression of Emotion: Stimuli and Tests | The Emotion Hexagon Test from Facial expressions of emotion: Stimuli and Test (FEEST) represents the primary outcome measure. The test uses 30 computer-manipulated images of faces from the Ekman and Friesen series to test recognition of basic emotions - anger, disgust, fear, happiness, sadness and surprise.Here we report the total score. The results are converted to a score of min.0 and max.120 correct for recognition of all six emotions. The higher the score, better is the ability to recognize emotions. | Mean | Standard Deviation | units on a scale |
|
| ATEC - Autism Treatment Evaluation Checklist | 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. | Mean | Standard Deviation | units on a scale |
|
| VABS - Vineland Adaptive Behaviour Scale | 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. | Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | ATEC - Autism Treatment Evaluation Checklist | 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. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks (Endpoint 1) plus 6 months follow up |
|
|
|
| Secondary | VABS - Vineland Adaptive Behaviour Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks (Endpoint 1) plus 6 months follow-up |
|
|
|
| Other Pre-specified | POMS - Profile of Mood States | Not Posted | 8 weeks (Endpoint 1) plus 6 months follow-up | Participants |
| Other Pre-specified | HADS - Hospital Anxiety & Depression Scale | 24-item scale (7 depression & 7 anxiety items) | Not Posted | 8 weeks (Endpoint 1) plus 6 months follow-up | Participants |
| Other Pre-specified | BDI - Beck Depression Inventory | 21-item measure of clinical depression | Not Posted | 8 weeks (Endpoint 1) plus 6 months follow-up | Participants |
| Other Pre-specified | Debriefing Interview Questionnaire | Covers: strategies; general experience of the process; adverse effects; | Not Posted | 8 weeks (Endpoint 1) | Participants |
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Endpoint 1 [VABS ABC] |
|
| 6 months follow-up [VABS COM] |
|
| 6 months follow-up [VABS DLS] |
|
| 6 months follow-up [VABS SOC] |
|
| 6 months follow-up [VABS ABC] |
|