Observational Study of Cortical Spreading Depression in Human Brain Trauma

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00803036

Acronym

COSBID-TBI

Enrollment

165

Registered

2008-12-05

Start date

2009-01-31

Completion date

2014-09-30

Last updated

2018-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Post-traumatic epilepsy questionnaire.	6, 12, and 24 months post-TBI

Countries

United Kingdom, United States

Outcome results