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

Conditions

• Severe Traumatic Brain Injury
• Traumatic Brain Injury (TBI) Patients

Eligibility Criteria

Sex

ALL

Age

22 Years - 85 Years

Healthy Volunteers

Accepted

Interventions

• SeeMe Multimodal Auditory Command Protocol — DIAGNOSTIC_TEST
  A 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

Study Details

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.

Key Dates

Start date

Mar 30, 2026

Status verified

Apr 2026

Primary completion

Dec 31, 2029

Completion

Dec 31, 2029

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: TBI Patients
  Patients with Traumatic Brain Injury receiving the SeeMe Auditory Stimulation protocol daily to detect covert motor responses
• Active Comparator: Healthy Control Cohort
  Awake, healthy volunteers receiving the SeeMe protocol to establish "ground truth" for normal voluntary motor signatures and algorithm sensitivity.
• Sham Comparator: Sedated/Paralyzed Patients
  Patients undergoing general anesthesia and pharmacological paralysis receiving the SeeMe protocol to establish the algorithm's specificity and "noise floor."

Primary Outcome Measure

Lead Time to Detection of Command-Following by SeeMe Compared With Blinded CRS-R Assessment [ Time Frame: From Day 1 until hospital discharge, typically within 45 days. ]

Central Contacts

• Sima Mofakham, PhD
  631-444-1278
  [email protected]

Locations (1)

Find similar trials in Stony Brook, NY

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