SeeMe: A Multimodal Behavioral-Electrophysiological Tool for Real-Time Detection of Motor Behavior in Brain Injury Patients
Trial ID: NCT07560631
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-03-30
Completion date: 2029-12
Sponsor: Stony Brook University
Collaborators: National Institute of Mental Health (NIMH)
Conditions: Traumatic Brain Injury (TBI) Patients; Severe Traumatic Brain Injury
Interventions: SeeMe Multimodal Auditory Command Protocol
Locations: Stony Brook University Hospital
Countries: United States
Enrollment: 80
Age range: 22 Years - 85 Years
Sex: ALL

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.

Eligibility criteria:
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

Outcomes:
Lead Time to Detection of Command-Following by SeeMe Compared With Blinded CRS-R Assessment