[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656548":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":34,"armGroups":43,"interventions":54,"overallOfficials":34,"centralContacts":62,"locations":68,"responsibleParty":85,"collaborators":34,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":34,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":34,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":34,"overallStatus":70,"whyStopped":34,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"KK Women's and Children's Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":34},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Change in Attention Threshold","Change in the game's adaptive attention threshold value, measured at each session, on a normalised scale between 0 to 1, where the greater value indicates greater sustained attention.","Baseline (Session 1) to final session (Session 12), over 10 weeks",{"measure":14,"description":15,"timeFrame":12},"Change in Relaxation Threshold","Change in the game's adaptive threshold value, measured at each session, according to the normalised scale between 0 and 1, where higher value means greater sustained relaxation.",{"measure":17,"description":18,"timeFrame":12},"Change in Response Time","Change in mean response time to in-game stimuli, measured in milliseconds, at each session.",{"measure":20,"description":21,"timeFrame":12},"Change in Alpha-Lateralization Index","Change in the alpha-lateralization index, a unitless measure derived from posterior EEG channels (P7\u002FP8, O1\u002FO2), ranging from -1 to +1, measured at each session.",{"measure":23,"description":24,"timeFrame":12},"Change in Beta-to-Alpha Power Ratio","Change in the ratio of EEG beta-band to alpha-band spectral power, a unitless ratio, measured at each session.",[26,30],{"measure":27,"description":28,"timeFrame":29},"Internalising problem score on Behavior Assessment System for Children, Third Edition (BASC-3)","Total internalising symptoms (anxiety, depression, somatisation) on BASC-3 questionnaire. T-scores for the BASC-3 Internalizing Problems composite range from a minimum of 20 to a maximum of 120. Higher scores indicate greater severity of mood disorder.","From enrollment to 20 weeks",{"measure":31,"description":32,"timeFrame":33},"Externalising symptoms score in Behavior Assessment System for Children, Third Edition (BASC-3)","Degree of change in total score for externalising symptoms (Hyperactivity, aggression, conduct problems) in BASC-3 questionnaire. Raw score will be converted to T-score with range from 20 to 120. Higher score suggests a high level of maladjustment or severe impairment","From enrollment to end of study 20 weeks",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"RANDOMIZED","CROSSOVER","SUPPORTIVE_CARE",{"masking":40,"maskingDescription":34,"whoMasked":41},"SINGLE",[42],"INVESTIGATOR",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"BCI","EXPERIMENTAL","Intervention then standard of care",[49],"Other: Brain-computer interface with neurofeedback with 3D game sessions",{"label":51,"type":46,"description":52,"interventionNames":53},"Usual care","Usual care followed by intervention",[49],[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"OTHER","Brain-computer interface with neurofeedback with 3D game sessions","12 sessions of BCI-NFT computer games over 10 weeks",[45,51],[61],"BCI-NFT",[63],{"name":64,"role":65,"phone":66,"phoneExt":34,"email":67},"Jia Hui Teo","CONTACT","+6563926042","teo.jia.hui@singhealth.com.sg",[69],{"facility":5,"status":70,"city":71,"state":34,"zip":34,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"RECRUITING","Singapore","SG",{"type":74,"coordinates":75},"Point",[76,77],103.85007,1.28967,{"lat":77,"lon":76},[80,82],{"name":81,"role":65,"phone":66,"phoneExt":34,"email":67},"Jia Hui Teo, MBBS",{"name":83,"role":65,"phone":84,"phoneExt":34,"email":34},"Nabil","6563947254",{"type":86,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Teo Jia Hui","Clinical Assistant Professor","100656548","cognitive-rehabilitation-using-neurofeedback-with-brain-computer-interface-100656548",false,"NCT07828496","Cognitive Rehabilitation Using Neurofeedback With Brain-computer Interface","Cognitive Rehabilitation Using Neurofeedback With Brain-computer Interface - CONNECT: A Prospective Randomised Controlled Trial","Normaitve cohort:\n\n\\- Patients with no history of epilepsy\n\nInclusion Criteria:\n\n* Post acquired brain injury (stroke, encephalitis, brain tumour, traumatic brain injury)\n* Epilepsy\n\nExclusion Criteria:\n\n* History of photosensitive seizures\n* Diagnosis of intellectual disability\n* Presence of psychotic symptoms\n* Diagnosis of attention deficit and hyperactivity disorder\n* Diagnosis of autism spectrum disorder\n* Children on methylphenidate\n* Children who are unable to cooperate with neuropsychological assessment of cognitive function",true,"ALL","7 Years","21 Years",{"count":101,"type":102},70,"ESTIMATED","INTERVENTIONAL",[105],"NA","The goal of this clinical trial is to determine whether a Brain-Computer Interface Neurofeedback Training (BCI-NFT) programme can improve cognitive outcomes, and whether electroencephalography (EEG)-based measures can serve as objective markers of cognitive impairment, in children and adolescents aged 7 to 21 years with acquired brain injury (ABI), including traumatic brain injury (TBI), stroke, encephalitis, brain tumour, or epilepsy.\n\nA group of children and adolescents aged 7 to 21 years without any history of brain injury or epilepsy will also be enrolled to provide normative EEG data for comparison.\n\nThe main questions the study aims to answer are:\n\n1. Can EEG-derived measures of sustained attention, relaxation, and selective attention detect and quantify cognitive impairment in children and adolescents following ABI?\n2. Does a structured BCI-NFT programme improve cognitive and behavioural outcomes, including attention, memory, and executive function, compared with standard care alone?\n\nResearchers will compare an Intervention Group, who will receive BCI-NFT in addition to standard cognitive rehabilitation, with a Waitlist-Control Group, who will initially receive standard care alone before subsequently crossing over to receive BCI-NFT. This design will allow researchers to determine whether BCI-NFT leads to greater improvements in cognitive and behavioural outcomes compared with standard care alone.\n\nParticipants in the main ABI cohort will:\n\n* Complete behavioural assessments using the Behavior Assessment System for Children, Third Edition (BASC-3), including parent and\u002For teacher reports.\n* Complete 12 BCI-NFT sessions over a 10-week period. Each session will last approximately 60 minutes. During each session, participants will wear a wireless EEG headset and interact with neurofeedback computer games designed to respond to their sustained attention, selective attention, and response time.\n* Repeat the BASC-3 behavioural assessments at the end of the study period.\n* Have undergone a recent neuropsychological assessment within the preceding 2 years and ongoing review by a neuropsychologist.\n\nParticipants in the normative EEG cohort, comprising children and adolescents without a history of brain injury or epilepsy, will attend a single study session. During this session, EEG activity will be recorded both at rest and while participants interact with a three-dimensional (3D) computer game. These recordings will provide normative EEG data against which findings from participants with ABI can be compared.",[108,109],"Acquired Brain Injury Including Stroke","Epilepsy","2026-09-17",{"date":112,"type":113},"2026-09-18","ACTUAL",{"date":115,"type":113},"2025-11-01",{"date":117,"type":102},"2028-06-30",{"name":5,"class":6},1]