SeeMe: Using Automated Facial Tracking to Detect Voluntary Behavior in Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-85
SponsorStony Brook University
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
SeeMe Multimodal Auditory Command Protocol
Diagnostic testA standardized, computer-controlled auditory stimulation (AS) protocol designed to elicit and quantify microscopic motor responses. Protocol Details: Stimuli: Participants are presented with five distinct auditory commands: 1) 'Stick out your tongue,' 2) 'Open your eyes,' 3) 'Show me a smile,' 4) 'Close your hands,' and 5) a neutral control command ('Today is a sunny day'). Timing: Each command is presented 10 times via single-use headphones with a randomized 30-45 second jittered interval between trials to distinguish stimulus-evoked responses from spontaneous arousal. Data Capture: Responses are captured using high-resolution video (Panasonic HC-2000X) at 0.03s temporal resolution and synchronized millisecond-level EEG/ECoG. Analysis: Displacement heatmaps are generated via facial pore vector analysis and classified using a bidirectional long short-term memory (LSTM) neural network to determine the statistical significance of motor initiation compared to a 15-minute resting base
Treatment groups
80 Participants
are divided into 3 treatment groupsGroup A: TBI PatientsExperimental treatment 1 intervention
Group B: Healthy Control CohortActive comparator 1 intervention
Group C: Sedated/Paralyzed PatientsSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Lead Time to Detection of Command-Following by SeeMe Compared With Blinded CRS-R Assessment
Number of days between the first SeeMe-detected significant stimulus-evoked motor response and the first blinded Coma Recovery Scale-Revised (CRS-R) assessment demonstrating command-following. A SeeMe-positive detection is defined as a stimulus-evoked movement that meets the prespecified criteria of a Kolmogorov-Smirnov statistic \>0.1 and a pixel displacement \>400. This stimulus-evoked movement must be detected reliably (at least 3 out of 10 trials). CRS-R examiners will be blinded to SeeMe outputs.
Time frame
From Day 1 until hospital discharge, typically within 45 days.Secondary outcomes
1
Diagnostic Performance of SeeMe for Subsequent Confirmed Command-Following
Sensitivity, specificity, positive predictive value, and negative predictive value of SeeMe-detected responses for subsequent blinded CRS-R-confirmed command-following.
Time frame
From Day 1 until hospital discharge, typically within 45 days.2
Rate of SeeMe-Detected Responsiveness in Participants Without Observable Command-Following at Enrollment
The percentage of patients labeled as "unresponsive" (GCS 3-8) who demonstrate statistically significant stimulus-evoked movements via SeeMe that are invisible to the naked eye.
Time frame
From Day 1 until hospital discharge, typically within 45 days.3
False Positive Rate of SeeMe in Pharmacologically Paralyzed Controls
The rate of "significant" movements detected by the SeeMe algorithm in the cohort of patients undergoing general anesthesia and pharmacological paralysis. This establishes the "noise floor" for the computer vision system.
Time frame
During the localized 60-minute window of the surgical anesthesia procedure.4
Correlation Between SeeMe Motor Initiation and Beta-Band Event-Related Desynchronization (ERD)
The Pearson correlation coefficient (r) used to assess the temporal relationship between the onset of facial/hand motor movements (as quantified by the SeeMe algorithm in pixels/second) and the magnitude of Beta-band (13-30 Hz) power suppression (measured in dB or muV\^2 on synchronized EEG or ECoG. This confirms the neurophysiological validity of the computer-vision detection. Unit of Measure: Correlation Coefficient (r)
Time frame
At each synchronized recording session from Day 1 through hospital discharge, typically within 45 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stony Brook University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov