SeeMe: A Multimodal Behavioral-Electrophysiological Tool for Real-Time Detection of Motor Behavior in Brain Injury Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Lead Time to Detection of Command-Following by SeeMe Compared With Blinded CRS-R Assessment
研究概览
简要总结
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.
详细描述
- 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. 3. 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. 4. Study Design and Methodology
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TBI Patients
Patients with Traumatic Brain Injury receiving the SeeMe Auditory Stimulation protocol daily to detect covert motor responses
干预措施: SeeMe Multimodal Auditory Command Protocol (Diagnostic Test)
Healthy Control Cohort
Awake, healthy volunteers receiving the SeeMe protocol to establish "ground truth" for normal voluntary motor signatures and algorithm sensitivity.
干预措施: SeeMe Multimodal Auditory Command Protocol (Diagnostic Test)
Sedated/Paralyzed Patients
Patients undergoing general anesthesia and pharmacological paralysis receiving the SeeMe protocol to establish the algorithm's specificity and "noise floor."
干预措施: SeeMe Multimodal Auditory Command Protocol (Diagnostic Test)
结局指标
主要结局
Lead Time to Detection of Command-Following by SeeMe Compared With Blinded CRS-R Assessment
时间窗: 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.
次要结局
- Diagnostic Performance of SeeMe for Subsequent Confirmed Command-Following(From Day 1 until hospital discharge, typically within 45 days.)
- Rate of SeeMe-Detected Responsiveness in Participants Without Observable Command-Following at Enrollment(From Day 1 until hospital discharge, typically within 45 days.)
- False Positive Rate of SeeMe in Pharmacologically Paralyzed Controls(During the localized 60-minute window of the surgical anesthesia procedure.)
- Correlation Between SeeMe Motor Initiation and Beta-Band Event-Related Desynchronization (ERD)(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(Assessed at the end of R61 model development and validation, approximately Year 3.)
- Long-term Functional Outcome via Glasgow Outcome Scale-Extended (GOS-E)(6 months and 12 months post-injury.)
- Longitudinal Consciousness Recovery via Coma Recovery Scale-Revised (CRS-R)(6 months and 12 months post-injury.)
研究者
Sima Mofakham
Associate Professor of Neurosurgery
Stony Brook University