Status:
COMPLETED
Spreading Depolarizations in Traumatic Brain Injury
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Brief Summary
This research aims to extend the application of spreading depolarization monitoring to non-surgical TBI patients, using intraparenchymal electrode arrays and scalp electroencephalography to detect dep...
Detailed Description
This study aims to develop the new clinical science of spreading depolarizations for routine monitoring of all TBI patients requiring intensive care. This will be accomplished by investigating automat...
Eligibility Criteria
Inclusion
- Enrollment in TRACK-TBI CA cohort
- Admission to intensive care
- Documented TBI \<24 hr before anticipated placement of electrodes
- Lobe of primary injury accessible for ECoG by burr hole or craniotomy access
- Age ≥ 18 years
- Acute brain CT for clinical care
- Visual acuity/hearing adequate for testing
- Fluency in English or Spanish
- Ability to obtain informed consent
Exclusion
- Significant polytrauma that would confound outcome assessment
- Prisoners or patients in custody
- Pregnancy
- Patients on psychiatric hold
- Major debilitating baseline mental health disorder that would interfere with follow-up and the validity of outcome
- Major debilitating neurological disease impairing baseline awareness, cognition, or validity of follow-up and outcome assessment
- Significant history of pre-existing conditions that would interfere with follow-up and outcome assessment
- Low likelihood of follow-up
- Current participation in an interventional trial
- Penetrating TBI
- Spinal cord injury with ASIA score of C or worse
- Bilateral unreactive pupils or other evidence of unsurvivable injury
- Evidence of coagulopathy (INR\>1.5 or thrombocytopenia) or infection, which contraindicate invasive monitoring
Key Trial Info
Start Date :
March 28 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2022
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT03379220
Start Date
March 28 2017
End Date
June 15 2022
Last Update
December 22 2025
Active Locations (7)
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1
University of California San Francisco
San Francisco, California, United States, 94110
2
University of Miami
Miami, Florida, United States, 33136
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
University of Cincinnati
Cincinnati, Ohio, United States, 45267