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Scientists explore less invasive brain monitoring for TBI patients

NCT ID NCT03379220

Knowledge-focused Sponsor: University of Cincinnati Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether special electrodes placed on the brain or scalp can detect abnormal brain waves called spreading depolarizations in people with traumatic brain injury. Researchers monitored 147 adults in intensive care to see if these methods could work without major surgery. The goal was to find safer, less invasive ways to track brain health after injury.

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.

Participants

147 people

The number who actually took part.

Started

Mar 2017

Finished

Jun 2022

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.

Who is studied

Approximately 189 patients admitted to intensive care for treatment of TBI will be enrolled. The study will be conducted as an addition to TRACK-TBI (Transforming Research and Clinical Knowledge in Traumatic Brain Injury), an observational study conducted at 11 sites in the United States. The present study will be implemented at 7 of the 11 sites: University of Cincinnati, University of Pennsylvania, University of Pittsburgh, University of Miami, Massachusetts General Hospital, University of California San Francisco, and Baylor College of Medicine.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Inclusion Criteria: 1. Enrollment in TRACK-TBI CA cohort 2. Admission to intensive care 3. Documented TBI \<24 hr before anticipated placement of electrodes 4. Lobe of primary injury accessible for ECoG by burr hole or craniotomy access 5. Age ≥ 18 years 6. Acute brain CT for clinical care 7. Visual acuity/hearing adequate for testing 8. Fluency in English or Spanish 9. Ability to obtain informed consent Exclusion Criteria: 1. Significant polytrauma that would confound outcome assessment 2. Prisoners or patients in custody 3. Pregnancy 4. Patients on psychiatric hold 5. Major debilitating baseline mental health disorder that would interfere with follow-up and the validity of outcome 6. Major debilitating neurological disease impairing baseline awareness, cognition, or validity of follow-up and outcome assessment 7. Significant history of pre-existing conditions that would interfere with follow-up and outcome assessment 8. Low likelihood of follow-up 9. Current participation in an interventional trial 10. Penetrating TBI 11. Spinal cord injury with ASIA score of C or worse 12. Bilateral unreactive pupils or other evidence of unsurvivable injury 13. Evidence of coagulopathy (INR\>1.5 or thrombocytopenia) or infection, which contraindicate invasive monitoring

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Traumatic brain injury

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • University of California San Francisco

    San Francisco, California, 94110, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

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