Current Enrolling Trials

Our office of clinical trials coordinates and conducts investigational studies for the Department of Neurosurgery.

Clinical research professionals work with physicians and nurses, in collaboration with the staff at UC Medical Center to evaluate the safety and efficacy of new devices, drugs, procedures and techniques and to improve the quality of patient care.

The UC Neurosurgery Department is currently conducting the following clinical trials:

TRAUMATIC BRAIN INJURY TRIALS

SD-II: Development and Validation of Spreading Depolarization (SD) Monitoring for TBI Management

Under the leadership of Dr. Jed Hartings, we are the lead and coordinating center for a national, multi-center study aimed at understanding spreading depolarizations, sometimes called “brain tsunamis”, a type of pathogenic brain activity often seen in TBI and other types of brain injuries. This study aims to: 1) Develop signal-processing methods for automated bedside detection of spreading depolarizations in both invasive (ECoG) and non-invasive EEG recordings. 2) Determine the incidence of spreading depolarizations in TBI patients requiring intensive care, using EEG, depth electrodes, and subdural strips, and 3) Determine whether spreading depolarizations are independently associated with worse neurologic outcomes across the continuum of TBI severity.

Lead Study Principal investigator: Jed Hartings, PhD

Site Principal Investigator: Laura Ngwenya, MD, PhD

ASTRAL

We are actively recruiting patients for a clinical study called ASTRAL. The ASTRAL study, sponsored by Biogen, is a double-blind, multidose, placebo-controlled, Phase 2 study to assess the safety and effectiveness of IV BIIB093 (also known as glibenclamide or glyburide) in patients with brain contusion. The study will enroll approximately 160 participants. Rationale: BIIB093 targets the SUR1-TRPM4 channel. Hypothesis: By blocking the SUR1-TRPM4 channel, BIIB093 may potentially reduce edema and associated secondary damage. Study Treatment: Continuous, 3-stage, 96-hour infusion of BIIB093 (low dose or high dose) or matching placebo.

Principal Investigator: Laura Ngwenya, MD, PhD, UC Neurosurgery

Brain Oxygen Optimization in Severe TBI Phase-3 (BOOST-3)

BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone. Both of these alternative strategies are used in standard care. It is unknown if one is more effective than the other. In both strategies the monitoring and goals help doctors adjust treatments including the kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. The results of this study will help doctors discover if one of these methods is more safe and effective.

Principal Investigator: Natalie Kreitzer, MD, UC Emergency Medicine

EpiBioS4Rx

The Epilepsy Bioinformatics Study for Antiepileptogenic Therapy (EpiBioS4Rx) is a large, international, multicenter Center without Walls (CWOW) to address this pressing need by using studies of animals and patients with traumatic brain injury (TBI) leading to post-traumatic epilepsy (PTE) to develop the techniques and patient populations necessary to carry out future cost effective full-scale clinical trials of epilepsy prevention therapies.

Principal Investigator: Brandon Foreman, MD, UC Neurology

CEREBROVASCULAR TRIALS

Blood Pressure After Endovascular Stroke Therapy-II (BEST-II)

The purpose of this study is to assess the safety of lowering blood pressure in acute stroke patients that are successfully treated with a mechanical thrombectomy procedure. Patients enrolled in this study are randomly assigned to one of the three systolic BP (SBP) targets: ≤180 mmHg, <160 mmHg, and <140 mmHg (40 patients in each group). Treatment begin soon after the blood clot causing the stroke is removed, using anti-hypertensive medication given intravenously with a goal to lower and maintain the SBP below assigned target for 24 hrs.

Principal Investigator: Charles Prestigiacomo, MD, UC Neurosurgery

CREST-2

Patients with narrowing in their carotid artery without stroke or stroke warning signs (TIAs or mini-strokes) caused by that artery are eligible to participate in a research study called CREST-2. CREST-2 study is comparing intensive medical management alone to intensive medical management used in combination with a procedure to remove plaque buildup from the carotid artery in the neck. For more information, visit: www.crest2trial.org

Principal Investigator: Matthew Flaherty, MD, UC Neurology

SPINE TRIALS

Jazz Band Spine Surgery Registry Study

The Jazz Band Spine Surgery Registry study enrolls patients who are undergoing thoracic and/or lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System. By collecting medical, imaging, and patient-reported into a comprehensive database, we seek to improve patient care and outcomes.

Principal Investigator: Rani Nasser, MD, UC Neurosurgery

Closed Trials or in Follow Up

• Minimally Invasive Surgery + rt-PA for ICH Evacuation (MISTIE III)
• Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)
• WEAVE™ Trial: Wingspan® Stent System Post Market Surveillance Study
• Invasive and Non-invasive monitoring  of SPreading depolarization by Electro Corticography in Trauma and stroke (INSPECT)
• INvestigating TREatments for the Prevention of secondary Injury and Disability following TBI (INTREPID)
• Cancer Genome Atlas Patient Enrollment and Specimen Qualification Criteria Grade II-IV Gliomas
• Rindopepimut/GM-CSF in Patients with Relapsed EGFRvIII-Positive Glioblastoma
• Dasatinib or Placebo Combined with Chemoradiotherapy for Glioblastoma
• First-in-Human Study Evaluating AMG 595 in Subjects with Recurrent Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII)
• EDGE-NEWTON: Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage
• COAST: Condition of Approval Study for the Treatment of Lumbar Spinal Stenosis with X-STOP® PEEK IPD®
• DBS Long Term Follow-Up
• CLEAR III (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage) Phase III
• The Injury and Traumatic Stress (INTRuST) Consortium Neuroimagin Acquisition and Archival
• The Injury and Traumatic Stress (INTRuST) Consortium Biorepository
• Acoustic Neuromas: Subtotal Resection & Radiosurgery
• Chiari Malformation Study
• RAMP: Prospective, Randomized, Multicenter Clinical Study Comparing Axial Lumbar Interbody Fusion (AxiaLIF®) and Transforaminal Lumbar Interbody Fusion (TLIF) Spinal Procedures
• Brain Tissue Oxygen Monitoring in Traumatic Brain Injury (BOOST II)
• Spreading Depression in Brain Trauma (COSBID-TBI)
• CREATE – Cognitive Remediation after Traumatic Exposure Trial
• Adherus™ Dural Sealant in Cranial Procedures
• Monitoring of Delayed Ischemia after Subarachnoid Hemorrhage
• Angio-Seal™ Vascular Closure Device Following Interventional Radiology Procedures
• PRET: Patients Prone to Recurrence after Endovascular Treatment
• Target Imaging for Assistance in Treatment of Parkinson's
• SLV334 in Traumatic Brain Injury
• Clazosentan in Aneurysmal Subarachnoid Hemorrhage (CONSCIOUS-3)
• Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON)
• Carotid Occlusion Surgery Study (COSS)
• Clazosentan in Aneurysmal Subarachnoid Hemorrhage
• INFUSE® Bone Graft for Spine Fusion
• Libra™ Deep Brain Stimulator for Parkinson's Disease
• Duragen Plus to Minimize Adhesions after Lumbar Discectomy
• Gliadel Wafers & Permanent I-125 Seeds for Glioblastoma
• Biomarkers for Subarachnoid Induced Cerebral Vasospasm
• IVH Removal: Intraventricular rt-PA
• Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST)
• Comparison of Dura Sealants for Cranial Surgery
• New Spinal Sealant for Dura Repair
• Eon™ Spinal Cord Stimulator for Chronic Back & Leg Pain
• Prevention of Disability after Spinal Cord Injury (Cethrin)
• Prevention of Seizures after Brain Injury
• Near-infrared Spectroscopy to Detect Bleeding in the Brain
• Brain Stimulation for Arm/Hand Weakness After a Stroke
• Assessment of Surgery for Cervical Spondylotic Myelopathy
• Lumbar Stabilization using the AxiaLif system
• Evaluation of the PathFinder™ System for Pedicle Screw Insertion
• Evaluation of the CODA Expandable Fusion Cage
• FlexiCore™ Artificial Disc for the Treatment of Discogenic Pain
• ChillerStrip™ Hypothermia System for Aneurysm Surgery
• Safety and Tolerability of DTI-015 in Patients with Recurrent GBM
• Hemicraniectomy and Durotomy Upon Deterioration from Infarction Related Swelling (HeADDFIRST)
• Evaluation of ForSite Device to Measure Pupillary Size
• National Acute Brain Injury Study: Hypothermia II
• Prevention of Vasospasm & New Infarction after Aneurysmal SAH Following Administration of Clazosentan
• Evaluation of a Single IV Dose of Dexanabinol in Patients Suffering from Severe TBI
• Procrit® (Epoetin Alfa) Administered Perioperatively Versus Standard of Care in Blood Conservation in Subjects Undergoing Major Elective Spinal Surgery
• DuraSeal™ System as an Adjunct to Sutured Dural Repair During Cranial Surgery