Observational Study of Cortical Spreading Depression in Human Brain Trauma

NCT00803036 | Completed DMC

• 2 other identifiers: 08-96-12-01CDMRP-W81XWH-08-2-0016
• Study Type: observational
• Target: 165
• Locations: 2 countries
• Sites: 5

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.

Conditions

Traumatic Brain Injury

Keywords

spreading cortical depression; electroencephalography; traumatic brain injury; intensive care; vascular hypotension; intracranial hypertension

Outcome Measures

Primary Outcomes (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.

  Six months post-TBI.

Secondary Outcomes (1)

• Post-traumatic epilepsy questionnaire.

  6, 12, and 24 months post-TBI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cincinnati: lead
• University of Miami: collaborator
• University of Pittsburgh: collaborator
• Virginia Commonwealth University: collaborator
• King's College London: collaborator

Study Sites (5)

University of Miami

Miami, Florida, 33136, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Related Links

• This study is conducted as a branch of COSBID, the Co-Operative Study of Brain Injury Depolarizations.

MeSH Terms

Conditions

Brain Injuries, Traumatic; Hypotension; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jed A. Hartings, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Professor

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: January 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2014
• Last Updated: January 31, 2018

Record last verified: 2018-01

Locations

US (4); GB (1)