[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636049":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":56,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":32,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":32,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":42,"whyStopped":32,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Stony Brook University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"TBI Patients","EXPERIMENTAL","Patients with Traumatic Brain Injury receiving the SeeMe Auditory Stimulation protocol daily to detect covert motor responses",[13],"Diagnostic Test: SeeMe Multimodal Auditory Command Protocol",{"label":15,"type":16,"description":17,"interventionNames":18},"Healthy Control Cohort","ACTIVE_COMPARATOR","Awake, healthy volunteers receiving the SeeMe protocol to establish \"ground truth\" for normal voluntary motor signatures and algorithm sensitivity.",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Sedated\u002FParalyzed Patients","SHAM_COMPARATOR","Patients undergoing general anesthesia and pharmacological paralysis receiving the SeeMe protocol to establish the algorithm's specificity and \"noise floor.\"",[13],[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DIAGNOSTIC_TEST","SeeMe Multimodal Auditory Command Protocol","A standardized, computer-controlled auditory stimulation (AS) protocol designed to elicit and quantify microscopic motor responses.\n\nProtocol Details:\n\nStimuli: Participants are presented with five distinct auditory commands: 1) 'Stick out your tongue,' 2) 'Open your eyes,' 3) 'Show me a smile,' 4) 'Close your hands,' and 5) a neutral control command ('Today is a sunny day').\n\nTiming: Each command is presented 10 times via single-use headphones with a randomized 30-45 second jittered interval between trials to distinguish stimulus-evoked responses from spontaneous arousal.\n\nData Capture: Responses are captured using high-resolution video (Panasonic HC-2000X) at 0.03s temporal resolution and synchronized millisecond-level EEG\u002FECoG.\n\nAnalysis: Displacement heatmaps are generated via facial pore vector analysis and classified using a bidirectional long short-term memory (LSTM) neural network to determine the statistical significance of motor initiation compared to a 15-minute resting base",[15,20,9],[31],"Computer-Vision Based Consciousness Assessment",null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Sima Mofakham, PhD","CONTACT","631-444-1278","sima.mofakham@stonybrookmedicine.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Stony Brook University Hospital","RECRUITING","Stony Brook","New York","11794","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-73.14094,40.92565,{"lat":52,"lon":51},[55],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Sima Mofakham","Associate Professor of Neurosurgery",[61],{"name":62,"class":63},"National Institute of Mental Health (NIMH)","NIH","100636049","seeme-using-automated-facial-tracking-to-detect-voluntary-behavior-in-brain-injury-100636049",false,"NCT07560631","SeeMe: Using Automated Facial Tracking to Detect Voluntary Behavior in Brain Injury","SeeMe: A Multimodal Behavioral-Electrophysiological Tool for Real-Time Detection of Motor Behavior in Brain Injury Patients","Group 1: Traumatic Brain Injury (TBI) Cohort\n\nInclusion Criteria:\n\n* Adults (22+) with a history of acute traumatic brain injury\n* Documented loss of consciousness with a Glasgow Coma Scale (GCS) score less than or equal to 8 upon hospitalization\n* Clinically stable as determined by the primary neurosurgery or ICU team\n* Intact auditory pathways as confirmed by BAERs\n* Family consent for study participation\n\nExclusion Criteria:\n\n* Hearing Impairment confirmed via absence of Brainstem Auditory Evoked Responses (BAERs) that would prevent the patient from hearing the auditory commands\n* No legal authorized representative (LAR) available to provide informed consent for the patients in a comatose state\n* Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe.\n* Pregnant women\n* Any previous history of traumatic brain injury\n* Any neurodegenerative disease such as dementia\n\nGroup 2: Healthy Control Cohort\n\nInclusion Criteria:\n\n* Adults 22+ with no history of neurological or psychiatric disorders\n* Normal baseline neurological examination\n* Intact auditory pathways\n* Ability to provide informed consent\n* Ability to follow simple auditory commands in English\n\nExclusion Criteria:\n\n* Hearing Impairment that would prevent the participant from hearing the auditory commands\n* Any previous history of severe traumatic brain injury (TBI)\n* Any neurodegenerative disease (e.g., dementia)\n* Any motor impairment (e.g., facial palsy, carpal tunnel syndrome) that would interfere with facial or hand movement tracking\n* Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe\n* Pregnant women\n\nGroup 3: Sedated\u002FAnesthetized Cohort\n\nInclusion Criteria:\n\n* Adults (22+) undergoing elective spine surgery\n* Requirement of general anesthesia and pharmacological paralysis (neuromuscular blockade) as part of the standard surgical procedure\n* Clinically stable for study procedures as determined by the anesthesia and surgical teams.\n* Intact auditory pathways\n* Ability to provide informed pre-operative consent\n\nExclusion Criteria:\n\n* Hearing Impairment that would prevent the patient from hearing the auditory commands\n* Any previous history of severe traumatic brain injury\n* Any neurodegenerative disease such as dementia\n* Significant baseline facial or hand motor deficits prior to the administration of anesthesia\n* Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe\n* Pregnant women",true,"ALL","22 Years","85 Years",{"count":76,"type":77},80,"ESTIMATED","INTERVENTIONAL",[80],"NA","Objective: This prospective interventional study introduces \"SeeMe,\" an automated, high-resolution computer vision platform designed to objectively quantify microscopic, auditory command-evoked movements in patients with Traumatic Brain Injury (TBI). Current clinical assessments, such as the Glasgow Coma Scale (GCS) and Coma Recovery Scale-Revised (CRS-R), rely on subjective human observation and often fail to detect low-amplitude motor responses, potentially misclassifying up to 25% of patients as unresponsive.\n\nMethodology: SeeMe utilizes vector analysis, cross-correlation, and deep neural networks (DNNs) to track individual facial pores and hand movements with sub-millimeter precision (0.5 mm) and high temporal resolution (0.03s). The study will enroll a cohort of 60-80 TBI patients, alongside healthy controls and pharmacologically paralyzed subjects, to validate SeeMe's sensitivity and specificity.\n\nPrimary Goals:\n\n1. Validation: Compare SeeMe's detection of voluntary motor recovery against gold-standard clinical examinations (CRS-R).\n2. Synchronization: Simultaneously record and time-lock electroencephalography (EEG) and electrocorticography (ECoG) with SeeMe-detected movements.\n3. Biomarker Identification: Characterize neural signatures (specifically Beta-band oscillations) associated with the return of voluntary behavior.\n\nImpact: By providing a real-time, objective measure of motor intention and execution, SeeMe aims to identify \"Cognitive-Motor Dissociation\" (CMD) earlier than current methods, facilitating more accurate prognostications and laying the framework for future closed-loop neuromodulation (e.g., Vagus Nerve Stimulation) to accelerate TBI recovery.",[83,84],"Traumatic Brain Injury (TBI) Patients","Severe Traumatic Brain Injury",[86,87,88,89,90,91,92,93],"Traumatic Brain Injury","Disorders of Consciousness","Coma","Cognitive-Motor Dissociation","Covert Awareness","Computer Vision","Deep Learning","Artificial Intelligence","2026-04-30",{"date":96,"type":97},"2026-05-05","ACTUAL",{"date":99,"type":97},"2026-03-30",{"date":101,"type":77},"2029-12",{"name":5,"class":6},1]