Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-04-18 @ 10:05 PM
Study NCT ID:
NCT02440451
Status:
COMPLETED
Last Update Posted:
2019-02-20
First Post:
2015-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rt-fMRI NF Intervention Study in ASD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mcbranco@fmed.uc.pt', 'phone': '+351239790000', 'title': 'Prof. Dr. Miguel Castelo-Branco', 'organization': 'University of Coimbra'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months (from baseline until 6 months follow-up assessment)', 'eventGroups': [{'id': 'EG000', 'title': 'Neurofeedback Using BCI', 'description': '16 (13 + 3 in case of dropoffs) ASD subjects\n\nNeurofeedback (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.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'FEEST - Facial Expression of Emotion: Stimuli and Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neurofeedback Using BCI', 'description': '16 (13 + 3 in case of dropoffs) ASD subjects\n\nNeurofeedback (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.'}], 'classes': [{'title': 'Endpoint 1', 'categories': [{'measurements': [{'value': '100.27', 'spread': '19.29', 'groupId': 'OG000'}]}]}, {'title': '6 months follow-up', 'categories': [{'measurements': [{'value': '100.79', 'spread': '20.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks (Endpoint 1) plus 6 months follow-up', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ATEC - Autism Treatment Evaluation Checklist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neurofeedback Using BCI', 'description': '16 (13 + 3 in case of dropoffs) ASD subjects\n\nNeurofeedback (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.'}], 'classes': [{'title': 'Endpoint 1', 'categories': [{'measurements': [{'value': '32', 'spread': '14.66', 'groupId': 'OG000'}]}]}, {'title': '6 months follow-up', 'categories': [{'measurements': [{'value': '19.64', 'spread': '8.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks (Endpoint 1) plus 6 months follow up', 'description': '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.\n\nThe 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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'VABS - Vineland Adaptive Behaviour Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neurofeedback Using BCI', 'description': '16 (13 + 3 in case of dropoffs) ASD subjects\n\nNeurofeedback (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.'}], 'classes': [{'title': 'Endpoint 1 [VABS COM]', 'categories': [{'measurements': [{'value': '74.87', 'spread': '14.95', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint 1 [VABS DLS]', 'categories': [{'measurements': [{'value': '76.93', 'spread': '16.46', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint 1 [VABS SOC]', 'categories': [{'measurements': [{'value': '66.73', 'spread': '16.42', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint 1 [VABS ABC]', 'categories': [{'measurements': [{'value': '67.13', 'spread': '15.22', 'groupId': 'OG000'}]}]}, {'title': '6 months follow-up [VABS COM]', 'categories': [{'measurements': [{'value': '79.79', 'spread': '13.69', 'groupId': 'OG000'}]}]}, {'title': '6 months follow-up [VABS DLS]', 'categories': [{'measurements': [{'value': '83.14', 'spread': '17.00', 'groupId': 'OG000'}]}]}, {'title': '6 months follow-up [VABS SOC]', 'categories': [{'measurements': [{'value': '71.43', 'spread': '15.36', 'groupId': 'OG000'}]}]}, {'title': '6 months follow-up [VABS ABC]', 'categories': [{'measurements': [{'value': '73.57', 'spread': '13.67', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks (Endpoint 1) plus 6 months follow-up', 'description': '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).\n\nThe 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).\n\nThe higher the score, better is the adaptive behavior.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'POMS - Profile of Mood States', 'timeFrame': '8 weeks (Endpoint 1) plus 6 months follow-up', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'HADS - Hospital Anxiety & Depression Scale', 'timeFrame': '8 weeks (Endpoint 1) plus 6 months follow-up', 'description': '24-item scale (7 depression \\& 7 anxiety items)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'BDI - Beck Depression Inventory', 'timeFrame': '8 weeks (Endpoint 1) plus 6 months follow-up', 'description': '21-item measure of clinical depression', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Debriefing Interview Questionnaire', 'timeFrame': '8 weeks (Endpoint 1)', 'description': 'Covers: strategies; general experience of the process; adverse effects;', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Neurofeedback Using BCI', 'description': '16 (13 + 3 in case of dropoffs) ASD subjects\n\nNeurofeedback (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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Started the intervention protocol.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'comment': 'Completed the intervention protocol.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': 'There was no significant events after participant enrollment, before group assignment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Neurofeedback Using BCI', 'description': '16 (13 + 3 in case of dropoffs) ASD subjects\n\nNeurofeedback (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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.92', 'groupId': 'BG000', 'lowerLimit': '16.83', 'upperLimit': '29.00'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Portugal', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'FEEST - Facial Expression of Emotion: Stimuli and Tests', 'classes': [{'categories': [{'measurements': [{'value': '98', 'spread': '19.30', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ATEC - Autism Treatment Evaluation Checklist', 'classes': [{'categories': [{'measurements': [{'value': '36.6', 'spread': '13.94', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '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.\n\nThe 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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'VABS - Vineland Adaptive Behaviour Scale', 'classes': [{'title': 'Baseline [VABS COM]', 'categories': [{'measurements': [{'value': '70.6', 'spread': '15.65', 'groupId': 'BG000'}]}]}, {'title': 'Baseline [VABS DLS]', 'categories': [{'measurements': [{'value': '74', 'spread': '17.15', 'groupId': 'BG000'}]}]}, {'title': 'Baseline [VABS SOC]', 'categories': [{'measurements': [{'value': '63.4', 'spread': '14.21', 'groupId': 'BG000'}]}]}, {'title': 'Baseline [VABS ABC]', 'categories': [{'measurements': [{'value': '63.4', 'spread': '13.52', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '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).\n\nThe 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).\n\nThe higher the score, better is the adaptive behavior.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The number of participants is similar to the assigned in the participant flow.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-14', 'size': 425277, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-10-10T06:45', 'hasProtocol': False}, {'date': '2017-02-14', 'size': 1674625, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-10-10T06:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2015-04-24', 'resultsFirstSubmitDate': '2018-10-11', 'studyFirstSubmitQcDate': '2015-05-06', 'lastUpdatePostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-11', 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'POMS - Profile of Mood States', 'timeFrame': '8 weeks (Endpoint 1) plus 6 months follow-up'}, {'measure': 'HADS - Hospital Anxiety & Depression Scale', 'timeFrame': '8 weeks (Endpoint 1) plus 6 months follow-up', 'description': '24-item scale (7 depression \\& 7 anxiety items)'}, {'measure': 'BDI - Beck Depression Inventory', 'timeFrame': '8 weeks (Endpoint 1) plus 6 months follow-up', 'description': '21-item measure of clinical depression'}, {'measure': 'Debriefing Interview Questionnaire', 'timeFrame': '8 weeks (Endpoint 1)', 'description': 'Covers: strategies; general experience of the process; adverse effects;'}], 'primaryOutcomes': [{'measure': 'FEEST - Facial Expression of Emotion: Stimuli and Tests', 'timeFrame': '8 weeks (Endpoint 1) plus 6 months follow-up', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'ATEC - Autism Treatment Evaluation Checklist', 'timeFrame': '8 weeks (Endpoint 1) plus 6 months follow up', 'description': '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.\n\nThe 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': 'VABS - Vineland Adaptive Behaviour Scale', 'timeFrame': '8 weeks (Endpoint 1) plus 6 months follow-up', 'description': '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).\n\nThe 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).\n\nThe higher the score, better is the adaptive behavior.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'pmid': '11280420', 'type': 'BACKGROUND', 'citation': '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': '10827445', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nIntervention Type is a Device (brain computer interface using brain imaging signals) and the specific Intervention Name is Neurofeedback.\n\nStructure: (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).', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive diagnostic results for ASD in:\n\nAutism Diagnostic Interview-Revised; Autism Diagnostic Observation Schedule; The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.\n\nExclusion Criteria:\n\n* Global Intelligence Quotient \\< 80\n* Associated medical condition such as epilepsy, neurocutaneous or other genetic syndromes, or other usual comorbidity in ASD samples'}, 'identificationModule': {'nctId': 'NCT02440451', 'acronym': 'NF-ASD', 'briefTitle': 'Rt-fMRI NF Intervention Study in ASD', 'organization': {'class': 'OTHER', 'fullName': 'University of Coimbra'}, 'officialTitle': 'Improving Facial Expression Identification in ASD: a Real-time fMRI Neurofeedback Approach', 'orgStudyIdInfo': {'id': 'IBILI-VB-2015-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurofeedback using BCI', 'description': '16 (13 + 3 in case of dropoffs) ASD subjects', 'interventionNames': ['Device: Neurofeedback using BCI']}], 'interventions': [{'name': 'Neurofeedback using BCI', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Neurofeedback using BCI']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Miguel S Castelo-Branco, M. D., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IBILI - Institute for Biomedical Imaging in Life Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Coimbra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Miguel Castelo-Branco', 'investigatorAffiliation': 'University of Coimbra'}}}}