Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-29 @ 3:35 AM
Study NCT ID:
NCT04002167
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2019-06-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Novel fNIRS Neurofeedback Intervention for Enhancement of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor:
Organization:
Raw JSON
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A general linear model is applied to recorded signal and the beta coefficients from the model are extracted as a proxy for brain activity in fronto-pariteal network which subserves working memory function. There is no established population mean for beta coefficient of brain activity. Higher (lower) beta coefficients reflect higher (lower) activation in the target brain network. A positive change indicates increased brain activity. Increased frontal-parietal activity reflects better engagement of this brain network during working memory performance.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data are included in the analysis'}, {'type': 'PRIMARY', 'title': 'Change in Working Memory Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neurofeedback (Phase I)', 'description': 'The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.'}, {'id': 'OG001', 'title': 'Waitlist (Phase I)', 'description': 'Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.12', 'spread': '15.70', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '12.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 weeks', 'description': 'Accuracy in an N-back working memory task was calculated as the percentage of correct responses to target stimuli.', 'unitOfMeasure': 'percent change in accuracy', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory T-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neurofeedback (Phase I)', 'description': 'The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.'}, {'id': 'OG001', 'title': 'Waitlist (Phase I)', 'description': 'Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.4', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '-0.85', 'spread': '7.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 weeks', 'description': 'BRIEF assesses everyday behavior associated with specific domains of the executive functions. BRIEF working memory T-score ranges from \\<30 to \\>100 with higher scores indicating larger impairment in working memory. Lower T-scores on BRIEF indicates better working memory. T-score of 50 indicates the population mean with a standard deviation of 10. BRIEF working memory T-score of 65 and higher is indicative of deficits in working memory.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), General Memory Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neurofeedback (Phase I)', 'description': 'The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.'}, {'id': 'OG001', 'title': 'Waitlist (Phase I)', 'description': 'Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '16.36', 'groupId': 'OG000'}, {'value': '9.38', 'spread': '11.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 weeks', 'description': 'WRAML-2 assesses clinical issues in learning and memory functions. WRAML-2 Working Memory Index score ranges from 50 to 150 with higher scores indicating better working memory performance', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Conners 3rd Edition ADHD Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neurofeedback (Phase I)', 'description': 'The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.'}, {'id': 'OG001', 'title': 'Waitlist (Phase I)', 'description': 'Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.21', 'spread': '10.61', 'groupId': 'OG000'}, {'value': '-1', 'spread': '3.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 weeks', 'description': 'Conners 3 will be used to measure changes in clinical ADHD symptoms. Conners 3 ADHD index score ranges from 0 to 100 with higher scores indicating elevated ADHD symptoms. Conners 3 ADHD index score of higher than 65 is indicative of ADHD diagnosis.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Conners 3rd Edition Inattention T-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neurofeedback (Phase I)', 'description': 'The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.'}, {'id': 'OG001', 'title': 'Waitlist (Phase I)', 'description': 'Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.8', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '6.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 weeks', 'description': 'Conners 3 will be used to measure changes in clinical inattention symptoms. Conners 3 inattention t-score ranges from \\<30 to \\>100 with higher scores indicating larger impairment in attention. T-score of 50 indicates the population mean with a standard deviation of 10. Inattention t-score of 65 and higher is indicative of deficits in attention.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neurofeedback (Phase I)', 'description': 'The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.'}, {'id': 'OG001', 'title': 'Waitlist (Phase I)', 'description': 'Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.72', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '2.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 weeks', 'description': 'NEPSY-II consists of a set of subtests measuring cognitive functions required for success in school. The subtests include auditory attention \\& response, inhibition, word-list interference, and comprehension of instructions. The composite scores were quantified by averaging the scores across sub-scales. A positive change in composite score suggests increased ability in subtest domains. The composite score below 8 suggest deficits. The composite scores range from 0 to 20; lower scores correspond to more deficits, and higher scores correspond to more abilities.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants with usable data were included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Continuous Performance Test (CPT) Accuracy', 'timeFrame': 'baseline and 6 weeks', 'description': 'CPT is standard test for measuring vigilance, sustained attention and inhibitory control.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Change in California Verbal Learning Test - Children's Version (CVLT-C) Score", 'timeFrame': 'baseline and 6 weeks', 'description': 'CVLT-C test measures performance in learning and recalling verbal materials', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Parent Stress Index 4th Edition (PSI-IV)', 'timeFrame': 'baseline and 6 weeks', 'description': 'PSI-IV evaluates the magnitude of stress in the parent-child system', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Neurofeedback (Phase I)', 'description': 'The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.'}, {'id': 'FG001', 'title': 'Waitlist (Phase I)', 'description': 'Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.'}, {'id': 'FG002', 'title': 'Cognitive Training (Phase II)', 'description': 'The Cognitive Training group will receive 12 sessions of computerized cognitive intervention in the lab.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Neurofeedback (Phase I)', 'description': 'The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.'}, {'id': 'BG001', 'title': 'Waitlist (Phase I)', 'description': 'Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who completed the protocol are included in the analyses'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-26', 'size': 292298, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-25T15:25', 'hasProtocol': True}, {'date': '2023-08-25', 'size': 85553, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-25T16:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2019-06-24', 'resultsFirstSubmitDate': '2023-08-25', 'studyFirstSubmitQcDate': '2019-06-26', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-22', 'studyFirstPostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Continuous Performance Test (CPT) Accuracy', 'timeFrame': 'baseline and 6 weeks', 'description': 'CPT is standard test for measuring vigilance, sustained attention and inhibitory control.'}, {'measure': "Change in California Verbal Learning Test - Children's Version (CVLT-C) Score", 'timeFrame': 'baseline and 6 weeks', 'description': 'CVLT-C test measures performance in learning and recalling verbal materials'}, {'measure': 'Change in Parent Stress Index 4th Edition (PSI-IV)', 'timeFrame': 'baseline and 6 weeks', 'description': 'PSI-IV evaluates the magnitude of stress in the parent-child system'}], 'primaryOutcomes': [{'measure': 'Change in Target Frontal-parietal Activity', 'timeFrame': 'baseline and 6 weeks', 'description': 'Change in activity in the target frontal-parietal network measured by functional near infrared spectroscopy (fNIRS) during an N-back working memory task. A general linear model is applied to recorded signal and the beta coefficients from the model are extracted as a proxy for brain activity in fronto-pariteal network which subserves working memory function. There is no established population mean for beta coefficient of brain activity. Higher (lower) beta coefficients reflect higher (lower) activation in the target brain network. A positive change indicates increased brain activity. Increased frontal-parietal activity reflects better engagement of this brain network during working memory performance.'}, {'measure': 'Change in Working Memory Performance', 'timeFrame': 'baseline and 6 weeks', 'description': 'Accuracy in an N-back working memory task was calculated as the percentage of correct responses to target stimuli.'}], 'secondaryOutcomes': [{'measure': 'Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory T-score', 'timeFrame': 'baseline and 6 weeks', 'description': 'BRIEF assesses everyday behavior associated with specific domains of the executive functions. BRIEF working memory T-score ranges from \\<30 to \\>100 with higher scores indicating larger impairment in working memory. Lower T-scores on BRIEF indicates better working memory. T-score of 50 indicates the population mean with a standard deviation of 10. BRIEF working memory T-score of 65 and higher is indicative of deficits in working memory.'}, {'measure': 'Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), General Memory Index Score', 'timeFrame': 'baseline and 6 weeks', 'description': 'WRAML-2 assesses clinical issues in learning and memory functions. WRAML-2 Working Memory Index score ranges from 50 to 150 with higher scores indicating better working memory performance'}, {'measure': 'Change in Conners 3rd Edition ADHD Index Score', 'timeFrame': 'baseline and 6 weeks', 'description': 'Conners 3 will be used to measure changes in clinical ADHD symptoms. Conners 3 ADHD index score ranges from 0 to 100 with higher scores indicating elevated ADHD symptoms. Conners 3 ADHD index score of higher than 65 is indicative of ADHD diagnosis.'}, {'measure': 'Change in Conners 3rd Edition Inattention T-score', 'timeFrame': 'baseline and 6 weeks', 'description': 'Conners 3 will be used to measure changes in clinical inattention symptoms. Conners 3 inattention t-score ranges from \\<30 to \\>100 with higher scores indicating larger impairment in attention. T-score of 50 indicates the population mean with a standard deviation of 10. Inattention t-score of 65 and higher is indicative of deficits in attention.'}, {'measure': 'Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) Composite Score', 'timeFrame': 'baseline and 6 weeks', 'description': 'NEPSY-II consists of a set of subtests measuring cognitive functions required for success in school. The subtests include auditory attention \\& response, inhibition, word-list interference, and comprehension of instructions. The composite scores were quantified by averaging the scores across sub-scales. A positive change in composite score suggests increased ability in subtest domains. The composite score below 8 suggest deficits. The composite scores range from 0 to 20; lower scores correspond to more deficits, and higher scores correspond to more abilities.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADHD', 'Working memory', 'functional near infrared spectroscopy (fNIRS)', 'magnetic resonance imaging (MRI)', 'Neurofeedback', 'Cognitive training', 'Neuromonitoring'], 'conditions': ['ADHD']}, 'descriptionModule': {'briefSummary': 'The proposed study is to test and validate a novel intervention that integrates computerized cognitive training with real-time neuromonitoring and neurofeedback to enhance working memory by probing the individualized neural systems underlying working memory. We will test the proposed intervention on children with ADHD with working memory deficits. The R61 proof-of-concept phase will assess the target engagement, effective dose and feasibility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria include:\n\n* Age from 7 to 11 years\n* Diagnosis and/or current symptoms of ADHD\n* Full-scale Intelligence quotient (IQ) ≥80\n* Behavior Rating Inventory of Executive Functions (BRIEF), Working Memory Scale t-score \\> 65\n* Allowed comorbidities include oppositional defiant disorder, learning disabilities excluding dyslexia, and mild anxiety and/or depression.\n\nExclusion criteria:\n\n* Presence of severe neurological or psychiatric disease other than those allowed under inclusion\n* Sensory deficits that would preclude participation in assessments or imaging\n* History of significant head trauma with loss of consciousness\n* Contraindications to MRI (e.g. metal implants or claustrophobia)\n* Enrollment in other intervention studies'}, 'identificationModule': {'nctId': 'NCT04002167', 'briefTitle': 'A Novel fNIRS Neurofeedback Intervention for Enhancement of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD)', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Novel Neuromonitoring Guided Cognitive Intervention for Targeted Enhancement of Working Memory', 'orgStudyIdInfo': {'id': '328066'}, 'secondaryIdInfos': [{'id': 'R61MH119289', 'link': 'https://reporter.nih.gov/quickSearch/R61MH119289', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurofeedback', 'description': 'The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.', 'interventionNames': ['Behavioral: Neurofeedback']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Training', 'description': 'The Cognitive Training group will receive 12 sessions of computerized cognitive intervention in the lab.', 'interventionNames': ['Behavioral: Cognitive training']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist', 'description': 'Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.'}], 'interventions': [{'name': 'Neurofeedback', 'type': 'BEHAVIORAL', 'description': 'The Neurofeedback group will receive the proposed intervention which integrates computerized working memory training with neuromonitoring and neurofeedback.', 'armGroupLabels': ['Neurofeedback']}, {'name': 'Cognitive training', 'type': 'BEHAVIORAL', 'description': 'The Cognitive training group will receive computerized working memory training with performance feedback.', 'armGroupLabels': ['Cognitive Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Hadi Hosseini', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hadi Hosseini', 'investigatorAffiliation': 'Stanford University'}}}}