NCT07560631 SeeMe: Using Automated Facial Tracking to Detect Voluntary Behavior in Brain Injury

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 80 participants in total. It began in 2026-03-30 with a primary completion date of 2029-12.

Brief Summary

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 and specificity. Primary Goals: 1. Validation: Compare SeeMe's detection of voluntary motor recovery against gold-standard clinical examinations (CRS-R). 2. Synchronization: Simultaneously record and time-lock electroencephalography (EEG) and electrocorticography (ECoG) with SeeMe-detected movements. 3. Biomarker Identification: Characterize neural signatures (specifically Beta-band oscillations) associated with the return of voluntary behavior. Impact: 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.

Eligibility 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

Contact & Investigator

Frequently Asked Questions

Related Trials