Actively Recruiting

Phase Not Applicable
Age: 22Years - 85Years
All Genders
Healthy Volunteers
NCT07560631

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

Led by Stony Brook University · Updated on 2026-05-05

80

Participants Needed

1

Research Sites

191 weeks

Total Duration

On this page

Sponsors

S

Stony Brook University

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 22Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 22 years or older with acute traumatic brain injury
  • Glasgow Coma Scale score of 8 or less at hospitalization
  • Clinically stable as determined by neurosurgery or ICU team
  • Intact auditory pathways confirmed by brainstem auditory evoked responses
  • Family consent obtained for participation
  • Adults aged 22 years or older with no neurological or psychiatric disorders for healthy controls
  • Normal baseline neurological exam for healthy controls
  • Ability to provide informed consent and follow simple auditory commands in English for healthy controls
  • Adults aged 22 years or older undergoing elective spine surgery with general anesthesia and pharmacological paralysis
  • Clinically stable for study procedures as determined by anesthesia and surgical teams
  • Intact auditory pathways for surgical patients
  • Ability to provide informed pre-operative consent for surgical patients
Not Eligible

You will not qualify if you...

  • Hearing impairment confirmed by absence of brainstem auditory evoked responses preventing hearing auditory commands
  • No legal authorized representative available to provide consent if patient is comatose
  • Any medical condition making participation unsafe as judged by investigator
  • Pregnant women
  • Previous history of traumatic brain injury (for healthy controls and sedated patients)
  • Any neurodegenerative disease such as dementia
  • Any motor impairment interfering with facial or hand movement tracking (healthy controls)
  • Significant baseline facial or hand motor deficits before anesthesia administration (sedated patients)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Stony Brook University Hospital

Stony Brook, New York, United States, 11794

Actively Recruiting

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Research Team

S

Sima Mofakham, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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