NCT06083441

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2019

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

6 years

First QC Date

October 4, 2023

Last Update Submit

October 10, 2023

Conditions

Disorder of ConsciousnessConsciousness, Loss ofTrauma, BrainTraumatic Brain InjuryAcute Brain Injury

Keywords

ConsciousnessAcute brain injuryConsciousness RecoveryConsciousness MeasurementFacial Motion AnalysisMicroscopic movementsTraumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

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

Diagnostic Test: SeeMeDiagnostic Test: Coma Recovery Scale-Revised (CRS-R)

Control

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

Diagnostic Test: SeeMeDiagnostic Test: Coma Recovery Scale-Revised (CRS-R)

Interventions

SeeMeDIAGNOSTIC_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.

Also known as: SeeMe session
Acute Brain Injury (ABI)Control
Coma Recovery Scale-Revised (CRS-R)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

Acute Brain Injury (ABI)Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers: Adults 18-85 years old with no history of a neurologically debilitating disease (i.e., dementia, glioblastoma, Alzheimer's, multiple sclerosis, major vessel stroke, previous severe TBI, etc.) that are recruited via flyer and word of mouth Patients in a coma: Adults 18-85 years old with no history of a neurologically debilitating disease that are comatose (GCS \< 9) due to an acute brain injury. Patients in a comatose state will be identified during neurosurgical consultation in the hospital by the study physicians

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

Related 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.

    PMID: 20729164BACKGROUND

  • 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.

    PMID: 31888182BACKGROUND

  • 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.

    PMID: 21926026BACKGROUND

  • 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.

    PMID: 30508782BACKGROUND

  • 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.

    PMID: 36897921BACKGROUND

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

    PMID: 16350986BACKGROUND

MeSH Terms

Conditions

Consciousness DisordersUnconsciousnessBrain Injuries, TraumaticBrain Injuries

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Sima Mofakham, PhD

    Stony Brook Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sima Mofakham, PhD

CONTACT

631-444-1278sima.mofakham@stonybrookmedicine.edu

Charles Mikell, MD

CONTACT

631-444-7328charles.mikell@stonybrookmedicine.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor and Director of Research

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 16, 2023

Study Start

June 16, 2019

Primary Completion

June 1, 2025

Study Completion

August 1, 2025

Last Updated

October 16, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)