Neurotrauma Clinical Trials

The Neurotrauma Clinical Trials Center 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 or spine trauma into various clinical trials under the direction of David O. Okonkwo, MD, PhD.  The clinical brain injury research is wide spanning and includes the conduct of clinical trials funded by the federal agencies and industry to study new therapies, novel brain monitoring, advanced neuroimaging, and biomarkers. 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:

Current Trials:

Investigating Treatments for the Prevention of Secondary Injury and Disability following TBI (Intrepid)

Multimodality Neuromonitoring in eXtreme Lateral Interbody Fusion (XLIF)

A Prospective, Concurrently-controlled, Multi-center Pivotal Trial for INFUSE® Bone Graft with the CAPSTONE® Spinal System and Posterior Supplemental Fixation for the Treatment of One-level or Two-level Symptomatic, Advanced Degenerative Disease of the Lumbosacral Spine Utilizing a Transforaminal Lumbar Interbody Fusion (TLIF) Approach

SyNAPSe®: A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Progesterone in Patients with Severe Traumatic Brain Injury

BOOST: A Phase 2, Randomized Clinical Trial of the Safety and Efficacy of Brain Tissue Oxygen (PbtO2) Monitoring in the Management of Severe Traumatic Brain Injury

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

AMPar Biomarker Screening: Validation of AMPA receptor peptide assay to improve diagnostic certainty of mild traumatic brain injury (mTBI)

Pending Trials:

Progesterone for the Treatment of Traumatic Brain Injury (ProTECT™ III)  

INTRUST: A Randomized Clinical Trial of Glyburide (RP-1127) for TBI

The HOPES Trial: HypOthermia for Patients requiring Evacuation of Subdural Hematoma: A Multicenter, Randomized Clinical Trial

A Double-Blind, Placebo-Controlled Study of AC105 in Patients with Acute Traumatic Spinal Cord Injury