Automated tool for detecting early recovery after brain injury
SeeMe: A Pilot Study Developing Predictive, Real-Time Consciousness Assessment Metrics Based on Facial Expression Changes
This study is testing a new tool that looks at how patients with brain injuries respond to sounds to see if it can help predict their recovery better than current methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Stony Brook University Academic / other |
| Locations | 1 site (Stony Brook, New York) |
| Trial ID | NCT06083441 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the prediction of recovery outcomes in patients with acute brain injury (ABI) by utilizing a novel tool called 'SeeMe.' This tool objectively assesses consciousness levels by analyzing facial motion in response to auditory commands, allowing for the detection of subtle recovery signs that traditional methods may miss. The study will involve comatose patients and healthy volunteers, measuring their responses over time to establish a baseline for comparison. By leveraging advances in machine learning and facial analysis, the research seeks to provide more accurate short-term predictions of recovery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are comatose due to acute brain injuries.
Not a fit: Patients with a history of neurologically debilitating diseases or those without a legal authorized representative may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate assessments of recovery potential in patients with brain injuries.
How similar studies have performed: While there is growing interest in facial analysis for neurological conditions, this specific approach using the 'SeeMe' tool is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stony Brook, New York
- Stony Brook University Hospital — Stony Brook, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sima Mofakham, PhD — Stony Brook Medicine
- Study coordinator: Sima Mofakham, PhD
- Email: sima.mofakham@stonybrookmedicine.edu
- Phone: 631-444-1278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.