New camera system spots hidden signs of awareness in brain injury patients
NCT ID NCT07560631
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new computer system called SeeMe that can detect tiny movements in people with severe traumatic brain injury (TBI). Current exams may miss these movements, leading to misdiagnosis. The study will involve 60-80 TBI patients and aims to see if SeeMe can find signs of awareness earlier than standard tests.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Group 1: Traumatic Brain Injury (TBI) Cohort Inclusion Criteria: * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stony Brook University Hospital
RECRUITINGStony Brook, New York, 11794, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Sleep patterns in coma may reveal who will wake up
- Could the type of IV fluid change brain injury recovery?
- A walk a day may reboot the brain after injury — trial puts it to the test
- Ear-Clip nerve zaps may wake hidden awareness after brain injury
- Gut-Brain link after severe head injury: a new clue to preventing further damage