SeeMe: Using Automated Facial Tracking to Detect Voluntary Behavior in Brain Injury
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.
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.
調査の概要
詳細な説明
- 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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Sima Mofakham, PhD
- 電話番号：631-444-1278
- メール：sima.mofakham@stonybrookmedicine.edu
研究場所
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New York
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Stony Brook、New York、アメリカ、11794
- 募集
- Stony Brook University Hospital
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コンタクト：
- Sima Mofakham, PhD
- 電話番号：631-444-1278
- メール：sima.mofakham@stonybrookmedicine.edu
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：TBI Patients
Patients with Traumatic Brain Injury receiving the SeeMe Auditory Stimulation protocol daily to detect covert motor responses
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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
他の名前：
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アクティブコンパレータ：Healthy Control Cohort
Awake, healthy volunteers receiving the SeeMe protocol to establish "ground truth" for normal voluntary motor signatures and algorithm sensitivity.
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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
他の名前：
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偽コンパレータ：Sedated/Paralyzed Patients
Patients undergoing general anesthesia and pharmacological paralysis receiving the SeeMe protocol to establish the algorithm's specificity and "noise floor."
|
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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Lead Time to Detection of Command-Following by SeeMe Compared With Blinded CRS-R Assessment
時間枠：From Day 1 until hospital discharge, typically within 45 days.
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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.
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From Day 1 until hospital discharge, typically within 45 days.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Diagnostic Performance of SeeMe for Subsequent Confirmed Command-Following
時間枠：From Day 1 until hospital discharge, typically within 45 days.
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Sensitivity, specificity, positive predictive value, and negative predictive value of SeeMe-detected responses for subsequent blinded CRS-R-confirmed command-following.
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From Day 1 until hospital discharge, typically within 45 days.
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Rate of SeeMe-Detected Responsiveness in Participants Without Observable Command-Following at Enrollment
時間枠：From Day 1 until hospital discharge, typically within 45 days.
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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.
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From Day 1 until hospital discharge, typically within 45 days.
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False Positive Rate of SeeMe in Pharmacologically Paralyzed Controls
時間枠：During the localized 60-minute window of the surgical anesthesia procedure.
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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.
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During the localized 60-minute window of the surgical anesthesia procedure.
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Correlation Between SeeMe Motor Initiation and Beta-Band Event-Related Desynchronization (ERD)
時間枠：At each synchronized recording session from Day 1 through hospital discharge, typically within 45 days.
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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) |
At each synchronized recording session from Day 1 through hospital discharge, typically within 45 days.
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Multi-Class Command Classification Performance of the Bidirectional LSTM Model
時間枠：Assessed at the end of R61 model development and validation, approximately Year 3.
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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").
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Assessed at the end of R61 model development and validation, approximately Year 3.
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Long-term Functional Outcome via Glasgow Outcome Scale-Extended (GOS-E)
時間枠：6 months and 12 months post-injury.
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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.
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6 months and 12 months post-injury.
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Longitudinal Consciousness Recovery via Coma Recovery Scale-Revised (CRS-R)
時間枠：6 months and 12 months post-injury.
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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.
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6 months and 12 months post-injury.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB2019--00199
- 1R61MH138612-01 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
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