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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.
Mission: To improve the quality of life for patients with neurosurgical disorders through scientific clinical research that advances disease understanding and contributes to evidence-based guidelines for optimal care.
Values:
Vision: To be nationally and internationally renowned for excellence in clinical neurosurgical research.
You can contact Clinical Trials to discuss enrollment or to learn more about current trials at:513-558-3122NSClinResearch@ucmail.uc.edu
INDICT: We are the lead and coordinating center for a national, multi-center study focused on spreading depolarizations (SD), sometimes called “brain tsunamis”, a type of pathogenic brain activity often seen in TBI and other types of brain injuries. The primary goals of this study are to determine (1) the feasibility of implementing a treatment protocol for intensive care of severe TBI that is guided by real-time SD monitoring, and (2) the effects of this protocol to reduce secondary injury and improve cerebral physiology. This study targets patients who had an emergency craniotomy or craniectomy to treat an acute TBI with the placement of a subdural electrode strip. Participants are randomized to either standard of care treatment or SD guided treatment. Data on SD occurrence is used to guide treatment in a tier-based therapeutic escalation and de-escalation protocol, with the intent being suppression of SDs. This trial is sponsored by the Department of Defense to learn how to treat brain-injured soldiers best.
Principal Investigator: Jed Hartings, PhD
Clinical trials registry: https://clinicaltrials.gov/study/NCT05337618?term=indict&rank=1
TRACK Studies: TRACK-TBI NET is a multi-faceted Phase 2 TBI clinical trial network that builds on the well-established infrastructure of its foundation: the longitudinal, observational TRACK-TBI study. This institutional and public-private partnership is comprised of 18 Clinical Enrollment/Study Sites, 7 Cores, and a Contract Research Organization, for a total of nearly 50 collaborating institutions, corporations, and philanthropic organizations. Following a decade of progress, the TRACK-TBI NETWORK is strategically positioned to transition from an observational natural history study to a robust platform for TBI intervention trials. Funded in part by the United States Department of Defense US Army Medical Materiel Development Activity (DoD USAMMDA) via the Medical Technology Enterprise Consortium, TRACK-TBI NET invites all members of the TBI research community, across academic, public, and private platforms, to propose candidate pharmaceutical agents for Phase 2 studies.
Principal Investigator: Dr. Laura Ngwenya
TRACK-TBI Network
Early Neuromodulation in TBI: The proposed study is a diagnostic/monitoring and treatment/intervention type of pilot clinical trial. The EEG monitoring of cognitive recovery is the diagnostic component while AtES is the proposed intervention. We have a parallel study design where patients with moderate to severe TBI will be randomly either assigned an active or sham A-tES in the acute phase of injury. Both the groups will receive active A-tES during the 3-month follow-up session. Potential subjects who are treated by co-I Dr Ngwenya and Dr Foreman presenting with moderate-severe TBI will be identified by clinical and research staff and/or co-Is in the neurosurgical services.
Principal Investigator: Ishita Basu, PhD
BEACH: Sponsored by the National Institute on Aging, this phase 2a pilot study aims to assess the safety and tolerability of drug MW189 in patients with Intracerebral Hemorrhage (ICH). In animal models of acute brain injuries such as ICH and Traumatic Brain Injury (TBI), MW189 attenuates neuroinflammation, reduces cerebral edema, and improves functional and cognitive performance. The trial seeks to establish if these targets are modified in humans with ICH. Participants are enrolled within 24h of their last known normal and randomized to receive either study drug (MW189) or placebo every 12 hours for 5 days.
Principal Investigator: Dr. Norberto Andaluz
Clinical trials registry: https://www.clinicaltrials.gov/study/NCT05020535
GTX-104-003: The purpose of this Phase 3 trial is to evaluate the safety and tolerability of GTX-104 (IV nimodipine) compared to oral nimodipine. Patients with aneurysmal subarachnoid hemorrhages (aSAH) will be enrolled and randomized to receive either oral nimodipine (as done as standard of care) or GTX-104 for up to 21 days. This trial is sponsored by Acasti Pharma.
Principal Investigator: Dr. Charles Prestigiacomo
Clinical Trials Registry: https://clinicaltrials.gov/study/NCT05995405
RESTORE: The objective of this post-market study is to evaluate outcomes such as successful revascularization, good functional outcome, revascularization time, and procedure related major neurological complications with the SOFIA® Flow Plus 6F Aspiration Catheter when used in conjunction with the direct aspiration as first line treatment technique for patients with acute ischemic stroke.
Clinical Trials Registry: https://clinicaltrials.gov/study/NCT04451525
ADOGWA GENE STUDIES: The goal of these UC initiated concurrent trials is to accelerate the development of individualized, targeted medical management to prevent and treat chronic post-surgical pain (CPSP) patients after spinal surgery. Enrolled patients will have samples collected to determine their CYP2D6 genotype, which determines how your body breaks down CYP2D6-metabolized opioids. Participants are then randomized to either the standard postoperative pain medication protocol OR CYP2D6 genotype-guided medication recommendation.
Principal Investigator: Dr. Owoicho Adogwa
MT-3921-A01: The purpose of this study is to compare the efficacy and safety of intravenous (IV) infusions of MT-3921 to placebo in subjects with acute traumatic cervical spinal cord injury. Subjects meeting eligibility criteria will enter a 6-month double-blind period. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double-blind manner. A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MT-3921 in Subjects with Acute Traumatic Cervical Spinal Cord Injury.
Principal Investigator: Dr. Justin Virojanapa
Clinical Trials Registry: https://clinicaltrials.gov/study/NCT04683848
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The UC Neurosurgery Department is currently conducting the following clinical trials:
Department ofNeurosurgery231 Albert Sabin WayPO Box 670515Cincinnati, OH 45267-0515
Mailing AddressUniversity of Cincinnati College of MedicineDepartment of NeurosurgeryPO Box 670515Cincinnati Ohio 45267-0515