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

Stony Brook University logo

Stony Brook University

Status

Enrolling

Conditions

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

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06083441
IRB2019-00199

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Acute Brain Injury (ABI)
Description:
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
Treatment:
Diagnostic Test: Coma Recovery Scale-Revised (CRS-R)
Diagnostic Test: SeeMe
Control
Description:
Healthy subjects will undergo SeeMe and CRS-R assessment once.
Treatment:
Diagnostic Test: Coma Recovery Scale-Revised (CRS-R)
Diagnostic Test: SeeMe

Trial contacts and locations

1

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Central trial contact

Sima Mofakham, PhD; Charles Mikell, MD

Data sourced from clinicaltrials.gov

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