NCT07560631 · Stony Brook University
SeeMe: Using Automated Facial Tracking to Detect Voluntary Behavior in Brain Injury
What this study is about
Objective: This forward-looking 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).
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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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Stony Brook, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations