Observational Study of Cortical Spreading Depression in Human Brain Trauma

Traumatic Brain Injury Clinical Trial

— COSBID-TBI  

Official title:

Spreading Depressions as Secondary Insults After Traumatic Injury to the Human Brain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803036
• Other study ID #: 08-96-12-01
• Secondary ID: CDMRP-W81XWH-08-
• Status: Completed
• Phase: N/A
• First received: December 4, 2008
• Last updated: January 30, 2018
• Start date: January 2009
• Est. completion date: September 2014

Study information

• Verified date: January 2018
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Depression
• Traumatic Brain Injury

Locations

Country	Name	City	State
United Kingdom	King's College Hospital	London
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of Miami	Miami	Florida
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (5)

Lead Sponsor	Collaborator
University of Cincinnati	King's College London, University of Miami, University of Pittsburgh, Virginia Commonwealth University

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-traumatic epilepsy questionnaire.		6, 12, and 24 months post-TBI

External Links

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