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

Traumatic Brain Injury (TBI) Trials

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

Cerebrovascular Trials

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.

Principal Investigator: Dr. Charles Prestigiacomo

Clinical Trials Registry: https://clinicaltrials.gov/study/NCT04451525

Spine Trials

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

Closed Trials or in Follow Up

• SD-II: Development and Validation of Spreading Depolarization (SD) Monitoring for TBI Management
• ASTRAL
• BOOST3
• EpiBioS4Rx
• Blood Pressure After Endovascular Stroke Therapy (BEST-II)
• CREST-2
• Jazz Band Spine Surgery Registry study 
• 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