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Completed

NCT Number: NCT00803036

Observational Study of Cortical Spreading Depression in Human Brain Trauma

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

King's College Hospital, London, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

    Time frame: Six months post-TBI.

Secondary outcomes

  1. Post-traumatic epilepsy questionnaire.

    Time frame: 6, 12, and 24 months post-TBI

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • King's College London
  • University of Miami
  • University of Pittsburgh
  • Virginia Commonwealth University

Registry information

Official study title

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

Acronym: COSBID-TBI

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Dec 5, 2008
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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