Clinical Trial: Spreading Cortical Depressions

The purpose of this study is to examine the occurrence, characterization and neurological outcome of cortical spreading depression (a form of seizure activity).

Cortical spreading depression is a result of the brain’s normal electrical circuitry being damaged by a brain injury. The frequency of this is unknown; however, some researchers have reported up to a 55% occurrence in a similar brain-injured population. The normal brain can recover from this seizure activity; however in the injured brain, it is unknown if recovery from this seizure activity is delayed. This seizure activity may impede the normal blood flow to adjacent areas of the brain, potentially impairing recovery.

In order to detect these electrical events early after a brain injury and determine whether they are harmful to the brain, it is necessary to continuously measure and monitor different aspects of altered brain function. The electrical activity will be examined and compared with the physiologic values displayed on the patient’s monitor (such as the heart rate, blood and brain pressure, blood flow, oxygenation values) during the course of five days after surgery.

It is of research interest to compare physical and psychological outcome (physical and mental recovery and abilities) after traumatic brain injury in this sub-population (group of brain injured patients requiring brain surgery). Our goal in this research is to understand further the relationship of cortical spreading depression and the physical and psychological outcomes in subjects who have had traumatic brain injuries.

We anticipate that 200 subjects with the relative type of injury will be enrolled in this study over a four year period at five study sites in the United States and Europe. At the University of Pittsburgh site, we anticipate entering 75 participants. Male and females are to be included within the age range of 18-80 years old.

For more information, please visit the study's page on the clinicaltrials.gov website.