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New camera system spots hidden signs of awareness in brain injury patients

NCT ID NCT07560631

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

22 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Brain Injuries, Traumatic Coma Consciousness Disorders traumatic brain injury

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Stony Brook University Hospital

    RECRUITING

    Stony Brook, New York, 11794, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.