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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:
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
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
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
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
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
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
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
Department ofNeurosurgery231 Albert Sabin WayPO Box 670515Cincinnati, OH 45267-0515
Mailing AddressUniversity of Cincinnati College of MedicineDepartment of NeurosurgeryPO Box 670515Cincinnati Ohio 45267-0515