Recruiting

SeeMe

Sponsor:

Stony Brook University

Code:

NCT07560631

Conditions

Traumatic Brain Injury (TBI) Patients

Severe Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Accepted

Interventions

SeeMe Multimodal Auditory Command Protocol

Study Details

Brief 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

Study ID

NCT07560631

Start date

Mar 30, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Accepted

Group 1: Traumatic Brain Injury (TBI) Cohort

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Group 2: Healthy Control Cohort

Inclusion Criteria:

  • Adults 22+ with no history of neurological or psychiatric disorders
  • Normal baseline neurological examination
  • Intact auditory pathways
  • Ability to provide informed consent
  • Ability to follow simple auditory commands in English

Exclusion Criteria:

  • 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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: TBI Patients

Patients with Traumatic Brain Injury receiving the SeeMe Auditory Stimulation protocol daily to detect covert motor responses

active comparator: Healthy Control Cohort

Awake, healthy volunteers receiving the SeeMe protocol to establish "ground truth" for normal voluntary motor signatures and algorithm sensitivity.

sham comparator: Sedated/Paralyzed Patients

Patients undergoing general anesthesia and pharmacological paralysis receiving the SeeMe protocol to establish the algorithm's specificity and "noise floor."

Interventions

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

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. ]

Central Contacts and Locations

Central contacts

Sima Mofakham, PhD

631-444-1278sima.mofakham@stonybrookmedicine.edu

Locations

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Sima Mofakham, PhD

631-444-1278sima.mofakham@stonybrookmedicine.edu

More Information

Sponsor

Stony Brook University

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • Traumatic Brain Injury
  • Disorders of Consciousness
  • Coma
  • Cognitive-Motor Dissociation
  • Covert Awareness
  • Computer Vision
  • Deep Learning
  • Artificial Intelligence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2026-05-05.