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New treatment option for Traumatic Brain Injury (TBI) Patients
Official title SeeMe: Using Automated Facial Tracking to Detect Voluntary Behavior in Brain Injury
ClinicalTrials.gov ID: NCT07560631
What this study is testing
- What it's testing
- Objective: This prospective interventional study introduces "SeeMe," an automated, high-resolution computer vision platform designed to objectively quantify microscopic, auditory command-evoked movements in patients with Traumatic Brain Injury (TBI). Current clinical assessments, such as the Glasgow Coma Scale (GCS) and Coma Recovery Scale-Revised (CRS-R), rely on subjective human observation and often fail to detect low-amplitude motor responses, potentially misclassifying up to 25% of patients as unresponsive.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 85. Healthy volunteers may be eligible.
You may be able to join if
- Group 1: Traumatic Brain Injury (TBI) Cohort
- Adults (22+) with a history of acute traumatic brain injury
- Documented loss of consciousness with a Glasgow Coma Scale (GCS) score less than or equal to 8 upon hospitalization
- Clinically stable as determined by the primary neurosurgery or ICU team
- Intact auditory pathways as confirmed by BAERs
You likely can't join if
- Hearing Impairment confirmed via absence of Brainstem Auditory Evoked Responses (BAERs) that would prevent the patient from hearing the auditory...
- No legal authorized representative (LAR) available to provide informed consent for the patients in a comatose state
- Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe.
- Pregnant women
- Any previous history of traumatic brain injury
- Any neurodegenerative disease such as dementia Group 2: Healthy Control Cohort Inclusion Criteria:
See the full eligibility criteria
- Group 1: Traumatic Brain Injury (TBI) Cohort
- Adults (22+) with a history of acute traumatic brain injury
- Documented loss of consciousness with a Glasgow Coma Scale (GCS) score less than or equal to 8 upon hospitalization
- Clinically stable as determined by the primary neurosurgery or ICU team
- Intact auditory pathways as confirmed by BAERs
- Family consent for study participation
- Hearing Impairment confirmed via absence of Brainstem Auditory Evoked Responses (BAERs) that would prevent the patient from hearing the auditory commands
- No legal authorized representative (LAR) available to provide informed consent for the patients in a comatose state
- Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe.
- Pregnant women
- Any previous history of traumatic brain injury
- Any neurodegenerative disease such as dementia Group 2: Healthy Control Cohort Inclusion Criteria:
- Adults 22+ with no history of neurological or psychiatric disorders
- Normal baseline neurological examination
- Intact auditory pathways
- Ability to provide informed consent
- Ability to follow simple auditory commands in English Exclusion Criteria:
- Hearing Impairment that would prevent the participant from hearing the auditory commands
- Any previous history of severe traumatic brain injury (TBI)
- Any neurodegenerative disease (e.g., dementia)
- Any motor impairment (e.g., facial palsy, carpal tunnel syndrome) that would interfere with facial or hand movement tracking
- Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe
- Pregnant women Group 3: Sedated/Anesthetized Cohort Inclusion Criteria:
- Adults (22+) undergoing elective spine surgery
- Requirement of general anesthesia and pharmacological paralysis (neuromuscular blockade) as part of the standard surgical procedure
- Clinically stable for study procedures as determined by the anesthesia and surgical teams.
- Intact auditory pathways
- Ability to provide informed pre-operative consent Exclusion Criteria:
- Hearing Impairment that would prevent the patient from hearing the auditory commands
- Any previous history of severe traumatic brain injury
- Any neurodegenerative disease such as dementia
- Significant baseline facial or hand motor deficits prior to the administration of anesthesia
- Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe
- Pregnant women
The study team makes the final eligibility decision.
Where it's taking place
- Stony Brook, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stony Brook, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.