TBI-SD

Principal Investigator: Lee Chung
Keywords: Traumatic Brain Injury , Spreading Depolarization Department: Neurology
IRB Number: 00100466 Co Investigator:  
Specialty: Neurology, Neurosurgery, Neurology
Sub Specialties: EEG, Trauma - Neuro Critical Care, Neuro Critical Care
Recruitment Status: Active, not recruiting

Contact Information

Lee Chung
lee.chung@hsc.utah.edu
865-850-3589

Brief Summary

Secondary deterioration that occurs in the days following traumatic brain injury (TBI) is a major cause of mortality and morbidity.  Its prevention is the goal of neurocritical care.  Secondary deterioration occurs as a consequence of known systemic (e.g., hypotension, hyperthermia) and intracranial (e.g., brain swelling, hemorrhage, seizure, vasospasm) insults, as well as unknown factors. Preliminary studies have shown that a cortical pathology known as spreading depolarization occurs in a large percentage of patients (~50%) in the days following TBI.  Spreading depolarizations (SD) are waves of mass neuronal/astrocytic depolarization that actively propagate a breakdown of ion homeostasis through injured brain cortex and may cause expansion of tissue damage.

The objective of this study is to determine whether SDs act as secondary insults and should be treated to improve neurologic outcome after TBI.  The occurrence, characteristics, and impact of SD on neurological outcome will be assessed in patients requiring a craniotomy to treat TBI.  A strip of electrodes is placed on the brain during neurosurgery to monitor SD by electrocorticography (ECoG) during neurocritical care.  The primary outcome measure will be the Glasgow Outcome Scale Extended (GOS-E) score at 6 months after injury.  Standard-of-care medical and physiologic data will be collected to achieve secondary objectives of determining the role of SD in the TBI disease process. 

Hypothesis:  The incidence/severity of SD activity occurring after TBI is significantly correlated with neurologic outcome (GOS-E at 6 months).   

Secondary Objectives:  1. Determine the relationship of SD severity/incidence with delayed deterioration, as measured, for instance, by PbrO2, ICP, cerebral blood flow, radiographic imaging, and neurologic exams.  2. Identify characteristics of initial injury, physiology and therapies (e.g. CT, glucose, blood pressure, temperature, medications, neuroimaging, etc) associated with SD occurrence.  3. Determine relationship of early SD occurrence with development of post-traumatic cognitive impairment and poor quality of life (cognitive and QoL assessments at 6 mo. follow-up).

Inclusion Criteria

All patients who require neurosurgical intervention (i.e. craniotomy) for treatment of TBI will be recruited for this study.  The craniotomy may be emergent, upon admission to the hospital, or become a management necessity within 7 days of the injury.  The subject population includes all races, ethnicities, and sex/gender groups.  There are no selection criteria based on race, ethnicity, sex/gender, or HIV status.  The subject population will reflect the demographics of the area in which each study site normally provides treatment for such injuries.  The proposed study will be conducted in the neuro critical care unit (NCCU) to include those patients aged 18+ years seeking treatment for TBI.

No special populations are to be included in this research, such as children, prisoners or pregnant women.  Although there are no known risks to these populations, we wish to exclude children and pregnant women.  There is no reason to unnecessarily endanger the unborn child or children until additional data on SD are obtained.  Also, a separate, age-specific study in children would be required due to logistic considerations of conducting this study in adult ICUs.  The data obtained from this study may provide additional data to warrant extension of similar, future studies to additional populations.          

Inclusion Criteria

  • Age: 18+ years old
  • Diagnosis of TBI
  • Craniotomy performed as per required medical treatment of TBI
  • Craniotomy surgery < 7 days after injury/ictus
  • GCS < 13 at time of decision for surgery
  • Expected neuromonitoring for > 72 hours

Exclusion Criteria

Exclusion Criteria

  • Any failure to meet inclusion criteria
  • Pregnancy
  • GCS 3 with fixed, dilated pupils