We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu
Trial record 1 of 175 for:    spreading depression
Previous Study | Return to List | Next Study

Observational Study of Cortical Spreading Depression in Human Brain Trauma (COSBID-TBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00803036
Recruitment Status : Completed
First Posted : December 5, 2008
Last Update Posted : January 31, 2018
University of Miami
University of Pittsburgh
Virginia Commonwealth University
King's College London
Information provided by (Responsible Party):
Jed Hartings, 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.

Condition or disease
Traumatic Brain Injury

Layout table for study information
Study Type : Observational
Actual Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spreading Depressions as Secondary Insults After Traumatic Injury to the Human Brain
Actual Study Start Date : January 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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. [ Time Frame: Six months post-TBI. ]

Secondary Outcome Measures :
  1. Post-traumatic epilepsy questionnaire. [ Time Frame: 6, 12, and 24 months post-TBI ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to study hospitals who require neurosurgery for acute traumatic brain injury.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • any failure to meet above criteria
  • pregnancy
  • GCS 3 with fixed, dilated pupils

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803036

Layout table for location information
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United Kingdom
King's College Hospital
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
University of Cincinnati
University of Miami
University of Pittsburgh
Virginia Commonwealth University
King's College London
Layout table for investigator information
Principal Investigator: Jed A. Hartings, PhD University of Cincinnati
Additional Information:
Layout table for additonal information
Responsible Party: Jed Hartings, Associate Research Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00803036    
Other Study ID Numbers: 08-96-12-01
First Posted: December 5, 2008    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Keywords provided by Jed Hartings, University of Cincinnati:
spreading cortical depression
traumatic brain injury
intensive care
vascular hypotension
intracranial hypertension
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System