Text Size

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

This study is currently recruiting participants.
Verified November 2010 by University of Cincinnati
Sponsor:
Collaborators:
University of Miami
University of Pittsburgh
Virginia Commonwealth University
King's College London
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00803036
First received: December 4, 2008
Last updated: November 8, 2010
Last verified: November 2010
History of Changes
  Purpose

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
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spreading Depressions as Secondary Insults After Traumatic Injury to the Human Brain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-traumatic epilepsy questionnaire. [ Time Frame: 6, 12, and 24 months post-TBI ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: January 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted to study hospitals who require neurosurgery for acute traumatic brain injury.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803036

Contacts
Contact: Jed A. Hartings, PhD 513-558-3567 jed.hartings@uc.edu

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Ross Bullock, MD, PhD     305-243-4456     RBullock@med.miami.edu    
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Jed A Hartings, PhD     513-295-2370     jed.hartings@uc.edu    
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: David O. Okonkwo, MD, PhD     412-647-2772     okonkwodo@upmc.edu    
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Bruce Mathern, MD     804-828-9165     bmathern@mcvh-vcu.edu    
United Kingdom
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Clemens Pahl, DM     44-7930-697838     clemenspahl@doctors.org.uk    
Sponsors and Collaborators
University of Cincinnati
University of Miami
University of Pittsburgh
Virginia Commonwealth University
King's College London
Investigators
Principal Investigator: Jed A. Hartings, PhD University of Cincinnati
  More Information

Additional Information:
This study is conducted as a branch of COSBID, the Co-Operative Study of Brain Injury Depolarizations.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jed A. Hartings, PhD, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00803036     History of Changes
Other Study ID Numbers: 08-96-12-01, CDMRP-W81XWH-08-2-0016
Study First Received: December 4, 2008
Last Updated: November 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Cincinnati:
spreading cortical depression
electroencephalography
traumatic brain injury
 intensive care
vascular hypotension
intracranial hypertension

Additional relevant MeSH terms:
Depression
Depressive Disorder
Brain Injuries
Behavioral Symptoms
Mood Disorders
Mental Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013