Neurotrauma Clinical Trials

The Neurotrauma Clinical Trials Center, under the direction of David O. Okonkwo, MD, PhD, is comprised of a team of clinicians who assume responsibilities over the screening and enrollment of patients with mild, moderate, and severe traumatic brain injury (TBI). Clinical brain injury research is wide spanning and includes clinical trials funded by federal agencies and industry to study new therapies, novel brain monitoring, advanced neuroimaging, and biomarkers.

The center also houses the National TBI Biospecimens Repository. This repository, under the direction of Ava Puccio, RN, PhD, supports the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study, a multi-center initiative funded by the National Institutes of Health (NIH), and is the largest centralized collection of biological samples from TBI patients in the United States.

The Department of Neurological Surgery has pioneered efforts using hypothermia and cerebral blood flow monitoring in the treatment of severe head injury and has conducted landmark investigations into the mechanisms of induction and recovery of head trauma and secondary injury.

Current clinical neurotrauma studies include:

BOOST3

Brain Oxygen Optimization in Severe TBI Phase-3 (BOOST3) is a research study to learn if either of two strategies for monitoring and treating patients with TBI in the intensive care unit (ICU) is more likely to help them get better.

Stem Cells for TBI

The purpose of this study is to evaluate the safety and effectiveness of a suspension of SB623 cells administered by injection around an area of traumatic injury in the brain. SB623 is derived from modified stem cells obtained from bone marrow of another adult human.

HDFT

The purpose of this study is to evaluate High Definition Fiber Tracking (HDFT), an MRI-based diagnostic method. Imaging results will be compared to neuropsychological testing results to potentially 'map' areas of damage following a TBI.

TRACK-TBI

The purpose of this research study is to measure and examine the chemicals released in the brain and blood after a head injury. Specifically, blood and cerebrospinal fluid (CSF, the fluids that surround the brain) will be examined to see how biomarkers (the chemicals contained in the fluids) relate to how severe the injury is and recovery after the injury (neurological outcome).

BTRC

The purpose of this research study is to measure and examine the chemicals released in the brain and blood after a head injury. Specifically, blood and cerebrospinal fluid (CSF, the fluids that surround the brain) will be examined to see how biomarkers (the chemicals contained in the fluids) relate to how severe the injury is and recovery after the injury (neurological outcome).

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).