SeeMe: Using Automated Facial Tracking to Detect Voluntary Behavior in Brain Injury (NCT07560631) | Clinical Trial Compass
RecruitingNot Applicable
SeeMe: Using Automated Facial Tracking to Detect Voluntary Behavior in Brain Injury
United States80 participantsStarted 2026-03-30
Plain-language 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.
Who can participate
Age range
22 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses automated facial tracking to detect whether someone can follow commands — how does that compare to the standard bedside assessments my loved one is already receiving, and could participating change anything about their current care?
2Since this study is measuring how quickly the SeeMe facial tracking system detects command-following compared to a blinded CRS-R assessment, does that mean my loved one would still get the standard evaluation, or would the facial tracking replace it during the study period?
3This trial is listed as Phase NA, which suggests it may be focused on testing a diagnostic tool rather than a treatment — so what would actually be different about my loved one's day-to-day care if they participated, and is there any physical risk from the facial tracking process itself?
4Given that this study is specifically for severe traumatic brain injury patients, how would you determine whether my loved one is a good fit, and are there any conditions or medications that might affect how well the facial tracking system works on them?
5If the SeeMe system detected signs of command-following that the standard CRS-R assessment missed, how would that information be used — would it change treatment decisions, or is this purely research data at this stage?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lead Time to Detection of Command-Following by SeeMe Compared With Blinded CRS-R Assessment
Timeframe: From Day 1 until hospital discharge, typically within 45 days.