RecruitingNANCT07560631

SeeMe: A Multimodal Behavioral-Electrophysiological Tool for Real-Time Detection of Motor Behavior in Brain Injury Patients

Sponsor: Stony Brook University

Trial Details

ConditionTraumatic Brain Injury (TBI) Patients, Severe Traumatic Brain Injury
InterventionSeeMe Multimodal Auditory Command Protocol
PhaseNA
StatusRecruiting
Participants80
Est. Completion1 Dec 2029
Last Updated5 May 2026

Primary Outcome

Lead Time to Detection of Command-Following by SeeMe Compared With Blinded CRS-R Assessment

Eligibility Criteria

Inclusion Criteria

Group 1: Traumatic Brain Injury (TBI) Cohort Inclusion Criteria: * Adults (22+) with a history of acute traumatic brain injury * Documented loss of consciousness with a Glasgow Coma Scale (GCS) score less than or equal to 8 upon hospitalization * Clinically stable as determined by the primary neurosurgery or ICU team * Intact auditory pathways as confirmed by BAERs * Family consent for study participation Exclusion Criteria: * Hearing Impairment confirmed via absence of Brainstem Auditory Evoked Responses (BAERs) that would prevent the patient from hearing the auditory commands * No legal authorized representative (LAR) available to provide informed consent for the patients in a comatose state * Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe. * Pregnant women * Any previous history of traumatic brain injury * Any neurodegenerative disease such as dementia Group 2: Healthy Control Cohort Inclusion Criteria: * Adults 22+ with no history of neurological or psychiatric disorders * Normal baseline neurological examination * Intact auditory pathways * Ability to provide informed consent * Ability to follow simple auditory commands in English Exclusion Criteria: * Hearing Impairment that would prevent the participant from hearing the auditory commands * Any previous history of severe traumatic brain injury (TBI) * Any neurodegenerative disease (e.g., dementia) * Any motor impairment (e.g., facial palsy, carpal tunnel syndrome) that would interfere with facial or hand movement tracking * Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe * Pregnant women Group 3: Sedated/Anesthetized Cohort Inclusion Criteria: * Adults (22+) undergoing elective spine surgery * Requirement of general anesthesia and pharmacological paralysis (neuromuscular blockade) as part of the standard surgical procedure * Clinically stable for study procedures as determined by the anesthesia and surgical teams. * Intact auditory pathways * Ability to provide informed pre-operative consent Exclusion Criteria: * Hearing Impairment that would prevent the patient from hearing the auditory commands * Any previous history of severe traumatic brain injury * Any neurodegenerative disease such as dementia * Significant baseline facial or hand motor deficits prior to the administration of anesthesia * Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe * Pregnant women

Trial Sites

Countries

United States
View Registry Entry

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