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

NCT ID: NCT06083441

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-16
• Study Completion Date: 2025-08-31

Brief Summary

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

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute Brain Injury (ABI)

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

SeeMe

Intervention Type: DIAGNOSTIC_TEST

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.

Coma Recovery Scale-Revised (CRS-R)

Intervention Type: DIAGNOSTIC_TEST

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

Control

Healthy subjects will undergo SeeMe and CRS-R assessment once.

SeeMe

Intervention Type: DIAGNOSTIC_TEST

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.

Coma Recovery Scale-Revised (CRS-R)

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

SeeMe

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.

Intervention Type: DIAGNOSTIC_TEST

Coma Recovery Scale-Revised (CRS-R)

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

SeeMe session

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Sima Mofakham

Assistant Professor and Director of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sima Mofakham, PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook Medicine

Locations

Stony Brook University Hospital

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sima Mofakham, PhD

Role: CONTACT

sima.mofakham@stonybrookmedicine.edu

631-444-1278

Charles Mikell, MD

Role: CONTACT

charles.mikell@stonybrookmedicine.edu

631-444-7328

Facility Contacts

Sima Mofakham, PhD

Role: primary

sima.mofakham@stonybrookmedicine.edu

631-444-7328

Charles Mikell, MD

Role: backup

charles.mikell@stonybrookmedicine.edu

631-444-7328

References

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Reference Type: BACKGROUND

PMID: 20729164 (View on PubMed)

Zhao Y, Xu J. A Convolutional Neural Network for Compound Micro-Expression Recognition. Sensors (Basel). 2019 Dec 16;19(24):5553. doi: 10.3390/s19245553.

Reference Type: BACKGROUND

PMID: 31888182 (View on PubMed)

Valstar MF, Pantic M. Fully automatic recognition of the temporal phases of facial actions. IEEE Trans Syst Man Cybern B Cybern. 2012 Feb;42(1):28-43. doi: 10.1109/TSMCB.2011.2163710. Epub 2011 Sep 15.

Reference Type: BACKGROUND

PMID: 21926026 (View on PubMed)

Chouinard B, Scott K, Cusack R. Using automatic face analysis to score infant behaviour from video collected online. Infant Behav Dev. 2019 Feb;54:1-12. doi: 10.1016/j.infbeh.2018.11.004. Epub 2018 Nov 30.

Reference Type: BACKGROUND

PMID: 30508782 (View on PubMed)

Saadon JR, Yang F, Burgert R, Mohammad S, Gammel T, Sepe M, Rafailovich M, Mikell CB, Polak P, Mofakham S. Real-time emotion detection by quantitative facial motion analysis. PLoS One. 2023 Mar 10;18(3):e0282730. doi: 10.1371/journal.pone.0282730. eCollection 2023.

Reference Type: BACKGROUND

PMID: 36897921 (View on PubMed)

Kalmar K, Giacino JT. The JFK Coma Recovery Scale--Revised. Neuropsychol Rehabil. 2005 Jul-Sep;15(3-4):454-60. doi: 10.1080/09602010443000425.

Reference Type: BACKGROUND

PMID: 16350986 (View on PubMed)

Other Identifiers

IRB2019-00199

Identifier Type: -

Identifier Source: org_study_id