💬In plain words
What the trial is, and whether it could suit you
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.
Methodology: 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 a
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
HealthTeky