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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06083441
• Other study ID #: IRB2019-00199
• Status: Recruiting
• Start date: June 16, 2019
• Est. completion date: August 2025

Study information

• Verified date: October 2023
• Source: Stony Brook University
• Contact: Sima Mofakham, PhD
• Phone: 631-444-1278
• Email: sima.mofakham[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Brain Injury
• Brain Injuries
• Brain Injuries, Traumatic
• Consciousness Disorders
• Consciousness, Loss of
• Disorder of Consciousness
• Trauma, Brain
• Traumatic Brain Injury
• Unconsciousness
• Wounds and Injuries

Intervention

Diagnostic Test:
• 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.
• 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

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Cheng F, Yu J, Xiong H. Facial expression recognition in JAFFE dataset based on Gaussian process classification. IEEE Trans Neural Netw. 2010 Oct;21(10):1685-90. doi: 10.1109/TNN.2010.2064176. Epub 2010 Aug 19. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.