Traumatic Brain Injury (TBI) PatientsNCT07560631
SeeMe: Using Automated Facial Tracking to Detect Voluntary Behavior in Brain Injury
A study testing SeeMe Multimodal Auditory Command Protocol in people with Traumatic Brain Injury (TBI) Patients and Severe Traumatic Brain Injury, run by Stony Brook University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury (TBI) Patients, Severe Traumatic Brain Injury
- What is being tested?
- SeeMe Multimodal Auditory Command Protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (22+) with a history of acute traumatic brain injury
- Documented loss of consciousness with a Glasgow Coma Scale (GCS) score less than or equal to 8 upon hospitalization
- Clinically stable as determined by the primary neurosurgery or ICU team
- Intact auditory pathways as confirmed by BAERs
- Family consent for study participation
- Adults 22+ with no history of neurological or psychiatric disorders
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- Normal baseline neurological examination
- Intact auditory pathways
- Ability to provide informed consent
- Ability to follow simple auditory commands in English
- Adults (22+) undergoing elective spine surgery
- Requirement of general anesthesia and pharmacological paralysis (neuromuscular blockade) as part of the standard surgical procedure
- Clinically stable for study procedures as determined by the anesthesia and surgical teams.
- Intact auditory pathways
- Ability to provide informed pre-operative consent
Who cannot join
- Hearing Impairment confirmed via absence of Brainstem Auditory Evoked Responses (BAERs) that would prevent the patient from hearing the auditory commands
- No legal authorized representative (LAR) available to provide informed consent for the patients in a comatose state
- Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe.
- Pregnant women
- Any previous history of traumatic brain injury
- Any neurodegenerative disease such as dementia
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- Group 2: Healthy Control Cohort
- Hearing Impairment that would prevent the participant from hearing the auditory commands
- Any previous history of severe traumatic brain injury (TBI)
- Any neurodegenerative disease (e.g., dementia)
- Any motor impairment (e.g., facial palsy, carpal tunnel syndrome) that would interfere with facial or hand movement tracking
- Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe
- Pregnant women
- Group 3: Sedated/Anesthetized Cohort
- Hearing Impairment that would prevent the patient from hearing the auditory commands
- Any previous history of severe traumatic brain injury
- Any neurodegenerative disease such as dementia
- Significant baseline facial or hand motor deficits prior to the administration of anesthesia
- Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
Sima Mofakham, PhD, 631-444-1278, sima.mofakham@stonybrookmedicine.edu
About this study
Official title: SeeMe: A Multimodal Behavioral-Electrophysiological Tool for Real-Time Detection of Motor Behavior in Brain Injury Patients
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.
Read more
Primary Goals:
- Validation: Compare SeeMe's detection of voluntary motor recovery against gold-standard clinical examinations (CRS-R).
- Synchronization: Simultaneously record and time-lock electroencephalography (EEG) and electrocorticography (ECoG) with SeeMe-detected movements.
- 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.
Read the detailed description
- Study Rationale and Scientific Gap Standard clinical assessments for Traumatic Brain Injury (TBI), such as the Glasgow Coma Scale (GCS) and Coma Recovery Scale-Revised (CRS-R), are limited by human subjectivity, examiner bias, and low spatiotemporal resolution. Recent multicenter studies indicate that up to 25% of patients who appear "unresponsive" at the bedside may exhibit "Cognitive-Motor Dissociation" (CMD)-a state of covert awareness where the brain intends to move, but motor output is too microscopic for the naked eye to detect. Misclassifying these patients as unresponsive negatively impacts clinical outcomes due to the potential withholding of rehabilitative resources. This study validates SeeMe, a multimodal platform designed to bridge this diagnostic gap by objectively quantifying microscopic behavior in real-time.
- 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.
- Future Directions The data gathered during this R61 phase-specifically the synchronization of SeeMe and EEG-will define the physiological triggers and milestones for Phase R33. In the subsequent phase, the SeeMe-EEG platform will be integrated with Vagus Nerve Stimulation (VNS). This closed-loop system will test the hypothesis that precisely-timed VNS pulses, paired with SeeMe-detected motor intentions, can facilitate the reorganization of motor circuits and accelerate the recovery of goal-directed behavior after TBI.
- Being tested
- SeeMe Multimodal Auditory Command Protocol
- Keywords
- Traumatic Brain Injury, Disorders of Consciousness, Coma, Cognitive-Motor Dissociation, Covert Awareness, Computer Vision, Deep Learning, Artificial Intelligence
- Medical subject headings
- Brain Injuries, Traumatic, Consciousness Disorders, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeeMe Multimodal Auditory Command ProtocolDiagnostic test
Also called Computer-Vision Based Consciousness Assessment
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 group | Role | What they receive |
|---|---|---|
| TBI Patients | Experimental | Patients with Traumatic Brain Injury receiving the SeeMe Auditory Stimulation protocol daily to detect covert motor responses Receives: Diagnostic Test: SeeMe Multimodal Auditory Command Protocol |
| Healthy Control Cohort | Active comparator | Awake, healthy volunteers receiving the SeeMe protocol to establish "ground truth" for normal voluntary motor signatures and algorithm sensitivity. Receives: Diagnostic Test: SeeMe Multimodal Auditory Command Protocol |
| Sedated/Paralyzed Patients | Sham comparator | Patients undergoing general anesthesia and pharmacological paralysis receiving the SeeMe protocol to establish the algorithm's specificity and "noise floor." Receives: Diagnostic Test: SeeMe Multimodal Auditory Command Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Day 1 until hospital discharge, typically within 45 days.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 6 months and 12 months post-injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start30 Mar 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI) PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sima Mofakham, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560631
- Sponsor's protocol ID
- IRB2019--00199
- Other IDs
- 1R61MH138612-01
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SeeMe: A Multimodal Behavioral-Electrophysiological Tool for Real-Time Detection of Motor Behavior in Brain Injury Patients
- ClinicalTrials.gov ID
- NCT07560631
- Acronym / sponsor ID
- IRB2019--00199
- Keywords
- Traumatic Brain Injury, Disorders of Consciousness, Coma, Cognitive-Motor Dissociation, Covert Awareness, Computer Vision, Deep Learning, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Validation: Compare SeeMe's detection of voluntary motor recovery against gold-standard clinical examinations (CRS-R).
- Synchronization: Simultaneously record and time-lock electroencephalography (EEG) and electrocorticography (ECoG) with SeeMe-detected movements.
- 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.
Detailed description
- Study Rationale and Scientific Gap Standard clinical assessments for Traumatic Brain Injury (TBI), such as the Glasgow Coma Scale (GCS) and Coma Recovery Scale-Revised (CRS-R), are limited by human subjectivity, examiner bias, and low spatiotemporal resolution. Recent multicenter studies indicate that up to 25% of patients who appear "unresponsive" at the bedside may exhibit "Cognitive-Motor Dissociation" (CMD)-a state of covert awareness where the brain intends to move, but motor output is too microscopic for the naked eye to detect. Misclassifying these patients as unresponsive negatively impacts clinical outcomes due to the potential withholding of rehabilitative resources. This study validates SeeMe, a multimodal platform designed to bridge this diagnostic gap by objectively quantifying microscopic behavior in real-time.
- 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.
- Future Directions The data gathered during this R61 phase-specifically the synchronization of SeeMe and EEG-will define the physiological triggers and milestones for Phase R33. In the subsequent phase, the SeeMe-EEG platform will be integrated with Vagus Nerve Stimulation (VNS). This closed-loop system will test the hypothesis that precisely-timed VNS pulses, paired with SeeMe-detected motor intentions, can facilitate the reorganization of motor circuits and accelerate the recovery of goal-directed behavior after TBI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TBI Patients | Experimental | Diagnostic Test: SeeMe Multimodal Auditory Command ProtocolPatients with Traumatic Brain Injury receiving the SeeMe Auditory Stimulation protocol daily to detect covert motor responses |
| Healthy Control Cohort | Active comparator | Diagnostic Test: SeeMe Multimodal Auditory Command ProtocolAwake, healthy volunteers receiving the SeeMe protocol to establish "ground truth" for normal voluntary motor signatures and algorithm sensitivity. |
| Sedated/Paralyzed Patients | Sham comparator | Diagnostic Test: SeeMe Multimodal Auditory Command ProtocolPatients undergoing general anesthesia and pharmacological paralysis receiving the SeeMe protocol to establish the algorithm's specificity and "noise floor." |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adults (22+) with a history of acute traumatic brain injury
- Documented loss of consciousness with a Glasgow Coma Scale (GCS) score less than or equal to 8 upon hospitalization
- Clinically stable as determined by the primary neurosurgery or ICU team
- Intact auditory pathways as confirmed by BAERs
- Family consent for study participation
Key exclusion criteria (20 listed)
- Hearing Impairment confirmed via absence of Brainstem Auditory Evoked Responses (BAERs) that would prevent the patient from hearing the auditory commands
- No legal authorized representative (LAR) available to provide informed consent for the patients in a comatose state
- Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe.
- Pregnant women
- Any previous history of traumatic brain injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeeMe Multimodal Auditory Command ProtocolAlso: Computer-Vision Based Consciousness AssessmentA 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 | Diagnostic test | Healthy Control Cohort, Sedated/Paralyzed Patients, TBI Patients |
Primary outcome
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.
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.
7 secondary outcomes
Diagnostic Performance of SeeMe for Subsequent 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
Time frame: From Day 1 until hospital discharge, typically within 45 days.
False Positive Rate of SeeMe in Pharmacologically Paralyzed Controls
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)
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
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)
Time frame: 6 months and 12 months post-injury.
Longitudinal Consciousness Recovery via Coma Recovery Scale-Revised (CRS-R)
Time frame: 6 months and 12 months post-injury.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SeeMe Multimodal Auditory Command Protocol in people with Traumatic Brain Injury (TBI) Patients and Severe Traumatic Brain Injury, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sima Mofakham, PhD (631-444-1278, sima.mofakham@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.