An interventional study of SeeMe Multimodal Auditory Command Protocol in Traumatic Brain Injury (TBI) Patients and Severe Traumatic Brain Injury, sponsored by Stony Brook University. Recruiting at 1 site in United States. Open to participants aged 22 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Stony Brook University · Not applicable, Interventional, and Diagnostic
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:
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.
The SeeMe Technological Framework SeeMe is an innovative computer-vision sensing platform that utilizes vector analysis, cross-correlation, and deep neural networks (DNNs) to track individual facial pores and hand landmarks.
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.
Multimodal Brain-Behavior Synchronization The primary objective of the R61 phase is the seamless integration of SeeMe with electrophysiological activity (EEG/ECoG). By time-locking microscopic motor initiation with neural oscillations, the investigators aim to identify objective biomarkers of recovery.
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.
Study Design and Methodology
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.
Clinical and Neuroethical Oversight
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.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 80 is above the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Stony Brook University is the lead sponsor of 197 studies on the registry; 36 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 11 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with Traumatic Brain Injury receiving the SeeMe Auditory Stimulation protocol daily to detect covert motor responses
Diagnostic Test: SeeMe Multimodal Auditory Command Protocol
Awake, healthy volunteers receiving the SeeMe protocol to establish "ground truth" for normal voluntary motor signatures and algorithm sensitivity.
Diagnostic Test: SeeMe Multimodal Auditory Command Protocol
Patients undergoing general anesthesia and pharmacological paralysis receiving the SeeMe protocol to establish the algorithm's specificity and "noise floor."
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
Also known as: Computer-Vision Based Consciousness Assessment
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.
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.
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.
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.
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.
Multi-Class Command Classification Performance of the Bidirectional LSTM Model
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: Assessed at the end of R61 model development and validation, approximately Year 3.
Long-term Functional Outcome via Glasgow Outcome Scale-Extended (GOS-E)
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.
Longitudinal Consciousness Recovery via Coma Recovery Scale-Revised (CRS-R)
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.
Time frame: 6 months and 12 months post-injury.
Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in the primary publication will be made available. This includes numerical vector data from SeeMe facial/hand tracking heatmaps, synchronized EEG/ECoG power spectra (Beta, Alpha, Delta, Theta bands), and blinded CRS-R clinical scores. To protect participant privacy, raw high-resolution video files will not be shared; however, processed, anonymized displacement time-series and algorithmic classification outputs will be provided. The Study Protocol and Statistical Analysis Plan will also be available.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will be made available beginning 6 months after the primary manuscript is published and will remain accessible for a period of 5 years. This allows the primary research team time to complete secondary analyses while ensuring the data remains useful for the scientific community during the R33 transition phase.
Access criteria: Data will be shared with researchers who provide a methodologically sound proposal and have obtained IRB approval from their home institution. Proposals must be directed to the Principal Investigator (Sima Mofakham). To gain access, data requestors will need to sign a Data Use Agreement (DUA) that strictly prohibits any attempt to re-identify participants or use raw signal data for non-academic purposes.
Data sharing details ↗ · renaissance.stonybrookmedicine.edu
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2029, 45 months after the start.
Of 442 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 64. This study's planned 45 months is close to that.
Counting every sponsor, half of 464 studies reached it within 40 months; a quarter within 22 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.