Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Location status: Recruiting
NCT Number: NCT07560631
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.
Interested in participating?
Request Info22 year–85 year
All sexes
Interventional
Not applicable
Stony Brook, New York, 11794, United States
Location status: Recruiting
Sub-millimeter Precision: The system offers high spatial precision (0.5 mm) and high temporal resolution (0.03s), allowing it to capture "micro-expressions" and low-amplitude motor responses (e.g., vertical eye movements or subtle mouth twitches) that escape clinical detection.
Advanced Classification: The investigators utilize a bidirectional long short-term memory (LSTM) network to classify heatmaps of facial movement. This ensures that detected responses are specific to the auditory command provided (e.g., "Show me a smile" vs. "Open your eyes") rather than generalized arousal or non-specific reflexive movements.
Beta-Band Signatures: The investigators focus on Beta-band Event-Related Desynchronization (ERD) and Synchronization (ERS) as signatures of motor planning and execution.
One-to-One Mapping: This multimodal approach provides a robust computational framework to synchronize brain activity with behavior, allowing us to map the "bigger picture" of recovery during the critical transition from coma to consciousness.
This prospective validation study will utilize three distinct cohorts (Total N = 80-100):
Cohort 1: Healthy Controls (n=10): Establishes the "ground truth" for robust, voluntary motor movements and baseline algorithm performance.
Cohort 2: Sedated/Anesthetized Controls (n=10): Patients undergoing spine surgery under general anesthesia/pharmacological paralysis provide a "zero-movement" baseline to quantify the algorithm's noise floor and establish specificity.
Cohort 3: Recovering TBI Patients (n=60-80): The primary clinical cohort.
Procedures: Participants listen to simple auditory commands (e.g., "Stick out your tongue," "Open your eyes," "Close your hands") alongside a control command ("Today is a sunny day") to distinguish auditory-evoked movements from true command following.
Comparison: SeeMe data will be collected daily and compared against blinded CRS-R assessments to determine the "detection lead time"-the number of days SeeMe identifies a response before the clinical team notes command following.
Acknowledging the vulnerability of the TBI population, the study incorporates two novel neuroethical safeguards:
Patient Advocate: Modeled on pioneering work in organ donation, a dedicated liaison will be appointed to act as a bridge between the research team and families, ensuring participant safety and well-being remain the central focus.
TBI-Affected Family Council: A consultative council of family members who have experienced TBI will review findings and provide guidance on the ethical communication of results to families.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Group 1: Traumatic Brain Injury (TBI) Cohort
Inclusion criteria
Exclusion criteria
Group 2: Healthy Control Cohort
Inclusion criteria
Exclusion criteria
Group 3: Sedated/Anesthetized Cohort
Inclusion criteria
Exclusion criteria
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
Other names: Computer-Vision Based Consciousness Assessment
Time frame: From Day 1 until hospital discharge, typically within 45 days.
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.
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.
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: During the localized 60-minute window of the surgical anesthesia procedure.
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: At each synchronized recording session from Day 1 through hospital discharge, typically within 45 days.
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: Assessed at the end of R61 model development and validation, approximately Year 3.
Multiclass classification accuracy of the LSTM model for distinguishing responses to prespecified auditory commands and neutral control statements. More specifically, we will measure the accuracy percentage of correctly classifying facial/hand responses to five distinct auditory commands (e.g., "Show me a smile" vs. "Open your eyes") versus neutral control commands ("Today is a sunny day").
Time frame: 6 months and 12 months post-injury.
The GOS-E is a standardized assessment of the patient's global functional recovery and level of independence. Scores range from 1 (Death) to 8 (Upper Good Recovery). This measure will be used to determine if the "Lead Time" or "Sensitivity" of early SeeMe motor detection in the acute phase is a significant predictor of long-term functional independence.
Time frame: 6 months and 12 months post-injury.
The CRS-R is the clinical gold standard for assessing consciousness. By performing this assessment at long-term follow-up, we can track the trajectory of patients who were "SeeMe positive" (detected by the algorithm) but "clinically negative" (undetected by humans) during their initial ICU stay to confirm if they eventually reached higher states of overt consciousness.
Contact information is provided by the study sponsor or research team.
Stony Brook University
Other
SeeMe: A Multimodal Behavioral-Electrophysiological Tool for Real-Time Detection of Motor Behavior in Brain Injury Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06871124
Brain Diseases, Brain Injuries
Cincinnati, Ohio, United States
View Trial DetailsNCT07606300
Brain Concussion, Brain Diseases
Columbus, Ohio, United States
View Trial DetailsNCT07269457
Brain Diseases, Brain Injuries
Lagos, Nigeria
View Trial DetailsNCT06899711
Brain Diseases, Brain Injuries
Baltimore, Maryland, United States
View Trial Details