Disorder of ConsciousnessNCT06083441
SeeMe: An Automated Tool to Detect Early Recovery After Brain Injury
An observational study of Disorder of Consciousness and Consciousness, Loss of, run by Stony Brook University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder of Consciousness, Consciousness, Loss of, Trauma, Brain
- What is being tested?
- SeeMe and Coma Recovery Scale-Revised (CRS-R)
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2019to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
Sima Mofakham, PhD, 631-444-7328, sima.mofakham@stonybrookmedicine.edu
Charles Mikell, MD, 631-444-7328, charles.mikell@stonybrookmedicine.edu
About this study
Official title: SeeMe: A Pilot Study Developing Predictive, Real-Time Consciousness Assessment Metrics Based on Facial Expression Changes
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.
Read the 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.
- Conditions
- Disorder of Consciousness, Consciousness, Loss of, Trauma, Brain, Traumatic Brain Injury, Acute Brain Injury
- Being tested
- SeeMe, Coma Recovery Scale-Revised (CRS-R)
- Keywords
- Consciousness, Acute brain injury, Consciousness Recovery, Consciousness Measurement, Facial Motion Analysis, Microscopic movements, Traumatic Brain Injury
- Medical subject headings
- Consciousness Disorders, Unconsciousness, Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeeMeDiagnostic test
Also called SeeMe session
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)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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: SeeMe; Diagnostic Test: Coma Recovery Scale-Revised (CRS-R) | |
| Control | Healthy subjects will undergo SeeMe and CRS-R assessment once. Receives: Diagnostic Test: SeeMe; Diagnostic Test: Coma Recovery Scale-Revised (CRS-R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Command Following
Length of time until an intervention is able to detect that a subject is following commands
Measured: Measured Daily from enrollment until subject is following commands or date of death of any cause, whichever comes first, up to 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start16 Jun 2019
- Primary completionJun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sima Mofakham, Stony Brook University
- Investigators
- Sima Mofakham, PhD, Principal investigator, Stony Brook Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083441
- Sponsor's protocol ID
- IRB2019-00199
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20729164Zhao Y, Xu J. A Convolutional Neural Network for Compound Micro-Expression Recognition. Sensors (Basel). 2019 Dec 16;19(24):5553. doi: 10.3390/s19245553.
PubMed 31888182Valstar 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.
PubMed 21926026Chouinard 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.
PubMed 30508782Saadon 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.
PubMed 36897921Kalmar K, Giacino JT. The JFK Coma Recovery Scale--Revised. Neuropsychol Rehabil. 2005 Jul-Sep;15(3-4):454-60. doi: 10.1080/09602010443000425.
PubMed 16350986
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SeeMe: A Pilot Study Developing Predictive, Real-Time Consciousness Assessment Metrics Based on Facial Expression Changes
- ClinicalTrials.gov ID
- NCT06083441
- Acronym / sponsor ID
- IRB2019-00199
- Conditions
- Disorder of Consciousness, Consciousness, Loss of, Trauma, Brain, Traumatic Brain Injury, Acute Brain Injury
- Keywords
- Consciousness, Acute brain injury, Consciousness Recovery, Consciousness Measurement, Facial Motion Analysis, Microscopic movements, Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 16 Jun 2019 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Brain Injury (ABI) | – | Diagnostic Test: SeeMe, Diagnostic Test: Coma Recovery Scale-Revised (CRS-R)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 | – | Diagnostic Test: SeeMe, Diagnostic Test: Coma Recovery Scale-Revised (CRS-R)Healthy subjects will undergo SeeMe and CRS-R assessment once. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeeMeAlso: SeeMe sessionA 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. | Diagnostic test | Acute Brain Injury (ABI), Control |
| 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 | Diagnostic test | Acute Brain Injury (ABI), Control |
Primary outcome
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.
Length of time until an intervention is able to detect that a subject is following commands
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Background: PubMed 20729164Cheng 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.
- Background: PubMed 31888182Zhao Y, Xu J. A Convolutional Neural Network for Compound Micro-Expression Recognition. Sensors (Basel). 2019 Dec 16;19(24):5553. doi: 10.3390/s19245553.
- Background: PubMed 21926026Valstar 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.
- Background: PubMed 30508782Chouinard 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.
- Background: PubMed 36897921Saadon 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.
- Background: PubMed 16350986Kalmar K, Giacino JT. The JFK Coma Recovery Scale--Revised. Neuropsychol Rehabil. 2005 Jul-Sep;15(3-4):454-60. doi: 10.1080/09602010443000425.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sima Mofakham, PhD principal investigator
Stony Brook Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder of Consciousness and Consciousness, Loss of, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sima Mofakham, PhD (631-444-1278, sima.mofakham@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06083441, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.