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

Sponsor
Stony Brook University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06083441
Collaborator
(none)
200
1
73.5
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: SeeMe
  • Diagnostic Test: Coma Recovery Scale-Revised (CRS-R)

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
SeeMe: A Pilot Study Developing Predictive, Real-Time Consciousness Assessment Metrics Based on Facial Expression Changes
Actual Study Start Date :
Jun 16, 2019
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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: 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.
Other Names:
  • SeeMe session
  • 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

    Control

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

    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.
    Other Names:
  • SeeMe session
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Detection of Command Following [Measured Daily from enrollment until subject is following commands or date of death of any cause, whichever comes first, up to 60 days.]

      Length of time until an intervention is able to detect that a subject is following commands

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stony Brook University Hospital Stony Brook New York United States 11794

    Sponsors and Collaborators

    • Stony Brook University

    Investigators

    • Principal Investigator: Sima Mofakham, PhD, Stony Brook Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sima Mofakham, Assistant Professor and Director of Research, Stony Brook University
    ClinicalTrials.gov Identifier:
    NCT06083441
    Other Study ID Numbers:
    • IRB2019-00199
    First Posted:
    Oct 16, 2023
    Last Update Posted:
    Oct 16, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Sima Mofakham, Assistant Professor and Director of Research, Stony Brook University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 16, 2023