SeeMe: An Automated Tool to Detect Early Recovery After Brain Injury

Study Overview
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Brief Summary
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Early prediction of outcomes after acute brain injury (ABI) remains a major unsolved problem. Presently, physicians make predictions using clinical examination, traditional scoring systems, and statistical models. In this study, we will use a novel technique, SeeMe, to objectively assess the level of consciousness in patients suffering from comas following ABI. SeeMe is a program that quantifies total facial motion over time and compares the response after a spoken command (i.e. open your eyes) to a pre-stimulus baseline.

Detailed Description
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Acute brain injury (ABI) recovers at a variable rate. While some progress has been made in predicting long-term outcomes in traumatic brain injury (TBI) and intracranial hemorrhage, there is a critical need for short-term prediction of outcomes, in the first days and weeks after injury. With advances in machine learning and artificial intelligence, there is a growing interest in facial analysis and its application in neurological and psychiatric disorders. Here we describe SeeMe, a novel automated objective measure of consciousness based on microexpression analyses in response to auditory commands. In measuring the smallest muscular movements undetectable by clinical observation, this technique has the high spatial resolution needed to detect hidden signs of recovery and the high temporal resolution needed to study neural circuits.

Official Title
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SeeMe: A Pilot Study Developing Predictive, Real-Time Consciousness Assessment Metrics Based on Facial Expression Changes

Conditions
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Disorder of Consciousness, Consciousness, Loss of, Trauma, Brain, Traumatic Brain Injury, Acute Brain Injury

Intervention / Treatment
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* Diagnostic Test: SeeMe
* Diagnostic Test: Coma Recovery Scale-Revised (CRS-R)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older Healthy Volunteers Comatose patients (patients with a GCS < 9) due to an acute brain injury (traumatic brain injury, spontaneous subarachnoid hemorrhage, severe meningoencephalitis, etc.) Exclusion Criteria: A history of a neurologically debilitating disease (i.e., dementia, glioblastoma, Alzheimer's, multiple sclerosis, major vessel stroke, previous severe TBI, etc.) Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe. Pregnant subjects Comatose patients without a legal authorized representative (LAR) Prisoners or wards of the state Persons who have not attained the legal age for consent to treatments or procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute Brain Injury (ABI)<br>Patients that have suffered an ABI resulting in Coma (Glasgow Coma Scale (GCS) < 9) will undergo SeeMe and CRS-R assessment once a day until hospital discharge | Diagnostic Test: SeeMe<br>* A video-recorded SeeMe command following assessment by a trained professional once a day Each session involves three command sets that are played from an audio recording 10 times over the course of 8 minutes. These commands are Stick out your tongue, Open your eyes, and Show me a smile Each command set is recorded separately for a total of 3 videos per session. These videos are then analyzed by SeeMe to detect if subjects are responding to commands.<br>* Other names: SeeMe session;Diagnostic Test: Coma Recovery Scale-Revised (CRS-R)<br>* A video-recorded CRS-R score assessment by a trained professional once a day. A score of 10 or greater, an auditory score >2, or an arousal score > 0 means that a subject is responding to commands<br>|
| Control<br>Healthy subjects will undergo SeeMe and CRS-R assessment once. | Diagnostic Test: SeeMe<br>* A video-recorded SeeMe command following assessment by a trained professional once a day Each session involves three command sets that are played from an audio recording 10 times over the course of 8 minutes. These commands are Stick out your tongue, Open your eyes, and Show me a smile Each command set is recorded separately for a total of 3 videos per session. These videos are then analyzed by SeeMe to detect if subjects are responding to commands.<br>* Other names: SeeMe session;Diagnostic Test: Coma Recovery Scale-Revised (CRS-R)<br>* A video-recorded CRS-R score assessment by a trained professional once a day. A score of 10 or greater, an auditory score >2, or an arousal score > 0 means that a subject is responding to commands<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Command Following | Length of time until an intervention is able to detect that a subject is following commands | Measured Daily from enrollment until subject is following commands or date of death of any cause, whichever comes first, up to 60 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Consciousness, Acute brain injury, Consciousness Recovery, Consciousness Measurement, Facial Motion Analysis, Microscopic movements, Traumatic Brain Injury