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

NCT07560631 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

SeeMe Multimodal Auditory Command Protocol

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

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07560631 on ClinicalTrials.gov