Observational Study of Cortical Spreading Depression in Human Brain Trauma
- Conditions
- Traumatic Brain Injury
- Registration Number
- NCT00803036
- Lead Sponsor
- University of Cincinnati
- Brief Summary
Since the primary damage from traumatic brain injury (TBI) is irreversible, the focus of medical management of TBI is preventing secondary injury that can be life-threatening and worsen patient outcome. Insight into the pathologic mechanisms of secondary injury, which are largely unknown, is required for developing better treatments.
In preliminary studies, the investigators have found that a pathologic brain activity, known as spreading depression, recurs in a large number of TBI patients in the first week after injury. Spreading depressions are short-circuits of brain function that arise spontaneously from an injury and spread repeatedly as waves into neighboring brain tissue. Animal research has shown that spreading depressions can cause secondary injury to the brain.
The primary objective of this observational study is to determine whether the occurrence or severity of spreading depression is related to worse neurologic recovery from TBI. Results from the study will determine whether monitoring of spreading depression should be used as a guide or target for improved medical management of the TBI patient.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
- 18-80 years old
- diagnosis of TBI
- craniotomy performed as per required treatment of TBI
- craniotomy surgery < 7 days after TBI
- GCS<13 at time of decision for surgery
- expected neuromonitoring for >72 hr
- any failure to meet above criteria
- pregnancy
- GCS 3 with fixed, dilated pupils
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of spreading depressions as assessed by continuous electrocorticography for 3-7 days after surgery. Primary neurologic outcome will be measured by the Glasgow Outcome Score - Extended. Six months post-TBI.
- Secondary Outcome Measures
Name Time Method Post-traumatic epilepsy questionnaire. 6, 12, and 24 months post-TBI
Trial Locations
- Locations (5)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
King's College Hospital
🇬🇧London, United Kingdom
University of Miami
🇺🇸Miami, Florida, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States