Recruiting

Observational Study

Sponsor:

Stony Brook University

Code:

NCT06083441

Conditions

Disorder of Consciousness

Consciousness, Loss of

Trauma, Brain

Traumatic Brain Injury

Acute Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

SeeMe

Coma Recovery Scale-Revised (CRS-R)

Study Details

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.

Conditions

Disorder of Consciousness

Consciousness, Loss of

Trauma, Brain

Traumatic Brain Injury

Acute Brain Injury

Study ID

NCT06083441

Start date

Jun 16, 2019

Status verified date

Oct, 2023

Completion date

Aug, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Control

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

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.

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sima Mofakham, PhD

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

Charles Mikell, MD

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

Locations

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Sima Mofakham, PhD

631-444-7328sima.mofakham@stonybrookmedicine.edu

Charles Mikell, MD

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

More Information

Sponsor

Stony Brook University

Last update posted

Oct 16, 2023

Last verified

Oct, 2023

Keywords

  • Consciousness
  • Acute brain injury
  • Consciousness Recovery
  • Consciousness Measurement
  • Facial Motion Analysis
  • Microscopic movements
  • Traumatic Brain Injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2023-10-16.