UC Department of Neurosurgery

Research

Clinical Trials

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

Nurses and physicians, in collaboration with the staff at Cincinnati area hospitals (University, Good Samaritan,and Christ), work together to evaluate the safety and efficacy of new devices, drugs, procedures and techniques and to improve the quality of patient care.

Research Match

Additional clinical trials opportunities can be found at ResearchMatch, a registry created through a large network of major academic institutions— including the University of Cincinnati—funded by the National Center for Research Resources, a component of the National Institutes of Health.

ResearchMatch will help match any type of approved study that is looking for people to participate in their study. You may be contacted about different research opportunities ranging from a survey you can do at home to a clinical trial that may involve you traveling to the researcher’s institution.

Current Trials

The UC Neurosurgery Department is conducting the following clinical trials:

Brain Tumor Trials

Bevacizumab with or without AMG 386 in patients with Recurrent Glioblastoma or Gliosarcoma

The purpose of this study is to find out the effect of bevacizumab with or without a new investigational drug, AMG 386, on you and your tumor. Bevacizumab is a protein that works by preventing new cancer-related blood vessel formation. The U.S. Food and Drug Administration (FDA) has approved bevacizumab for the treatment of recurrent glioblastoma. However, treatment with bevacizumab alone has only modestly improved overall survival in patients with this type of brain tumor. For this reason, other drugs, such as AMG 386, are being evaluated.

Principal investigator: Kevin Redmond, MD
Sponsor: RTOG 1122

Rindopepimut/GM-CSF with Temozolomide for EGFRvIII-positive Glioblastoma
The purpose of this research study is to find out whether adding an experimental vaccine product called rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug called temozolomide helps to shrink brain tumors or possibly prevents brain tumors from growing which may help patients with brain tumors live longer than treatment with temozolomide alone. more info >>

Principal investigator: Rekha Chaudhary, MD
Sponsor: Celldex Therapeutics, CDX110-04

Rindopepimut/GM-CSF in Patients with Relapsed EGFRvIII-Positive Glioblastoma
The purpose of this study is to find out whether adding the investigational drug rindopepimut and GM-CSF to bevacizumab (also known as Avastin) helps to shrink brain tumors, prevent brain tumors from growing, or help subjects with brain tumors live longer than treatment with bevacizumab alone. more info >>

Principal investigator: Rekha Chaudhary, MD
Sponsor: Celldex Therapeutics, CDX110-06

DCVax®-Brain for Glioblastoma Multiforme (GBM)
The purpose of this study is to determine whether DCVax-Brain can slow the growth and recurrence of your brain tumor and whether DCVax-Brain can extend overall survival. Other goals of the study are to test the safety and activity of DCVax-Brain and to determine whether the study agent causes an immune response (how your body recognizes and defends itself against substances that appear foreign and harmful to your body) against your cancer cells as compared to standard treatment or another experimental treatment. more info >>

Principal investigator: Rekha Chaudhary, MD
Sponsor: Northwest Biotherapeutics, 020221

Acoustic Neuromas: Subtotal Resection & Radiosurgery
The purpose of this study is to analyze the effectiveness of subtotal removal followed by radiosurgery compared to complete removal for patients with large acoustic neuromas. more info >>

Principal investigator: Philip Theodosopoulos, MD
Sponsor: Investigator initiated

First-in-Human Study Evaluating AMG 595 in Subjects with Recurrent Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII)

Principal investigator: Rekha Chaudhary, MD
Sponsor: 20090505

Dasatinib or Placebo Combined with Chemoradiotherapy for Glioblastoma

Principal investigator: Rekha Chaudhary, MD
Sponsor: NCCTG N0877

Radiation Therapy with or without Temozolomide for Low-Grade Gliomas
This study is being conducted to compare the effects of adding the chemotherapy agent, temozolomide, to radiation for patients with low grade gliomas, WHO grade II astrocytoma, oligodendroglioma, or oligoastrocytoma.

Principal investigator: Luke Pater, MD
Sponsor: CTSU E3F05

Phase I/II Study of ABT-888 Combined with Temozolomide in Recurrent GBM

Principal investigator: Kevin Redmond, MD
Sponsor: RTOG 0929

Natural History of Postoperative Cognitive Function, Quality of Life, and Seizure Control in Patients with Supratentorial Low-Risk, Grade II Glioma

Principal investigator: Kevin Redmond, MD
Sponsor: RTOG 0925

Rituximab, Methotrexae, Procarbazine, Vincristine, and Cytarabine with and without Low-dose Whole-Brain Radiotherapy for Primary CNS Lymphoma

Principal investigator: Kevin Redmond, MD
Sponsor: RTOG 1114

Trental and Vitamin E for Prophalaxis of Radiation Necrosis
The purpose of this study is to determine whether the use of Trental and Vitamin E can help reduce the incidence of radiation necrosis (a lesion that usually occurs at the original tumor site) after radiosurgery. These two drugs are commonly used to treat radiation necrosis when it occurs but the hope is that these drugs can be used to prevent radiation necrosis from ever occurring.

Principal investigator: Ronald Warnick, MD
Sponsor: BTC-W1

Cancer Genome Atlas Patient Enrollment and Specimen Qualification Criteria Grade II-IV Gliomas

Principal investigator: Chris McPherson, MD
Sponsor: NIH 1308

A high throughput, sensitive and non-invasive technique for detection and quantification of EGFRvIII mutation in the peripheral blood of GBM patients

Principal investigator: Mustapha Bahassi, PhD
Sponsor: Investigator initiated

Head and Spine Tissue Bank and Registry
The purpose of this study is to collect tissue samples from patients with tumors involving the head, brain and spine. Researchers will then use the tissue samples at some point in the future to study how to prevent, diagnose and better treat these tumors.

Principal investigator: Christopher McPherson, MD

Ohio Brain Tumor Study
The study is a tissue bank that includes four sites in the State of Ohio.

Principal investigator: Christopher McPherson, MD

Cerebrovascular Trials

CLEAR III (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage) Phase III
The purpose of this research study is to define precisely the long-term effects of dissolving ventricular blood clots (blood in the ventricles or open spaces of the brain) with rt-PA, on the recovery of physical abilities of patients who have been diagnosed with cerebral hemorrhage. more info >>

Principal Investigator: Opeolu Adeoye, MD
Sponsor: National Institutes of Health

Wingspan™ Stent for Blocked Brain Arteries
The purpose of this study is to monitor the effectiveness of the Wingspan Stent System to open arteries in the brain that have become blocked by a clot or narrowed by plaque.

Principal investigator: Andrew Ringer, MD

Neuroform™ Stent for Wide-neck Aneurysms
The purpose of this study is to monitor the effectiveness of the Neuroform Stent in treating wide-neck aneurysms in the brain.

Principal investigator: Andrew Ringer, MD
Sponsor: Boston Scientific

Onyx Liquid Embolic System HD-500
The purpose of this study is to monitor the effectiveness of the Onyx Liquid Embolic System in treating aneurysms in the brain.

Principal investigator: Andrew Ringer, MD

CORDIS ENTERPRISE™ Vascular Reconstruction Device & Delivery System
The purpose of this study is to monitor the effectiveness of the Cordis Enterprise Device in treating aneurysms in the brain.

Principal investigator: Andrew Ringer, MD
Sponsor: Codman & Shurtleff

Familial Intracranial Aneurysm (FIA) Study

The purpose of this study is to identify the genes that may be important in the development of intracranial aneurysms. more info >>

Principal investigator: Joseph Broderick, MD
Sponsor: National Institutes of Health

Spine Trials

COAST: Condition of Approval Study for the Treatment of Lumbar Spinal Stenosis with X-STOP® PEEK IPD® in Moderately Symptomatic Patients
This study is designed to supplement pre-market safety and effectiveness data with information on the longer-term device performance in a population of patients with moderately impaired physical function at preoperative baseline who elect to undergo X-STOP® surgery.

Principal investigator: Christopher McPherson, MD
Sponsor: Medtronic Spine

Chiari Malformation Study
The goal of the study is to assess the utility of novel, MR-based hydrodynamic measures of spinal canal resistance and compliance by showing: (1) differences between adult patients diagnosed with Chiari Malformation (CM) and healthy, age/gender-matched volunteers; and (2) difference within the CM patient group before and after surgical treatment. The significance of the current study will be to demonstrate the importance of cerebral spinal fluid hydrodynamics in CM patients. As such, a new and more accurate method to assist in standard clinical diagnosis and treatment of CM may be possible.

Principal investigator: John Tew, MD
Sponsor: National Institutes of Health (NIH)

Parkinson's Trials

DBS Long Term Follow-Up
The purpose of this research study is to monitor the long-term safety and efficacy of bilateral stimulation of the subthalamic nucleus (STN) when using the Libra™/Libra™ XP Deep Brain Stimulation System to attempt to reduce some of the symptoms of advanced Parkinson’s disease that are not adequately controlled with medication. In order to participate in this research study you must have completed the prior study, C-04-01. You must still have the implanted system from that study.

Principal Investigator: George Mandybur, MD
Sponsor: Advanced Neuromodulation Systems, Inc. (ANS) d./b./a. St. Jude Medical Neuromodulation Division

Traumatic Brain Injury Trials

Invasive and Non-Invasive Monitoring of Spreading Depolarization by ElectroCorticography in Trauma and Stroke (INSPECT)
The aim of this study is to investigate methods of recording spreading depolarizations in non-surgical patients with acute brain injury.

Principal investigator: Jed Hartings, PhD
Sponsor: Department of Defense

Brain Tissue Oxygen Monitoring in Traumatic Brain Injury (BOOST II)
The purpose of this study is to find out which treatments that doctors prescribe to patients who have traumatic brain injury are the best. Treatment using a brain tissue oxygen monitor to measure the pressure of oxygen in the brain (pBtO2) will be measured against treatment using only an intracranial pressure monitor (ICP). By review the outcomes of the different treatment regimens, the investigators hope to identify what offers the most beneficial outcome for patients.

Principal investigator: Norberto Andaluz, MD
Sponsor: National Institute of Neurological Disorders and Stroke

Spreading Depression in Brain Trauma (COSBID-TBI)
The purpose of this study is to examine a form of brain seizure activity and its impact on recovery from brain injury. more info>

Principal investigator: Jed Hartings, PhD
Sponsor: Department of Defense

The Injury and Traumatic Stress (INTRuST) Consortium Biorepository
The purpose of this study is to create a repository to store human blood and blood products for future research. These studies will help us learn more about Post Traumatic Stress Disorder (PTSD), Traumatic Brain Injury (TBI), and other illnesses.

Principal Investigator: Norberto Andaluz, MD
Sponsor: US Army Medical Research & Material Command

The Injury and Traumatic Stress (INTRuST) Consortium Neuroimagin Acquisition and Archival
The purpose of this study is to collect and store brain images for future research studies. These studies will allow us to look at the size, shape, and structural connections of the brain and help us learn more about Post Traumatic Stress Disorder (PTSD), Traumatic Brain Injury (TBI), and other illnesses. This information will help us better understand how differences in brain structures may affect mood, motivation, how we react to stress, and other kinds of behaviors. They may also help us understand the risks for developing certain illnesses and how people respond to certain treatments.

Principal Investigator: Norberto Andaluz, MD
Sponsor: United States Army Medical Research And Material Command

CREATE – Cognitive Remediation after Traumatic Exposure Trial
The purpose of this research study is to learn about the effectiveness of two medications in reducing symptoms such as difficulties with memory, attention, and other thinking processes in participants with Posttraumatic Stress Disorder and/or Mild Traumatic Brain Injury. The two study drugs consist of either the drug methylphenidate (Ritalin) or galantamine (Razadyne). Download info flyer (PDF)