Clinical Trials

NEUROSURGERY CLINICAL RESEARCH CONTACT INFORMATION:
Stephanie Wilbrand, PhD 608-265-9248 wilbrand@neurosurgery.wisc.edu

FOR ADDITIONAL INFORMATION OR OTHER STUDIES THE UW IS CONDUCTING:
https://clinicaltrials.uwhealth.org/

BRAIN TUMOR
Please Visit:
Carbone Cancer Center Clinical Trials

PEDIATRICS

Title: HCRN. Hydrocephalus Clinical Research Network Core Data Project: Characterizing Patients Populations within the HCRN
Investigator: Dr. Raheel Ahmed, MD, PhD
Sponsor: University of Utah School of Medicine

To establish and maintain a neurosurgical hydrocephalus patient event database to investigator the clinical management of pediatric Hydrocephalus. The University of Wisconsin School of Medicine and Public Health and the American Family Children’s Hospital are on of 30 sites that are part of the Clinical Centers of the Hydrocephalus Clinical Research Network.

Title: DNA Methylation in Familial Chiari I Malformation
Investigator: Dr. Bermans Iskandar, MD and Dr. Reid Alisch, PhD
Sponsor: The American Syringomyelia & Chiari Alliance Project (ASAP)

This study hypothesizes that familial Chiari I is epigenetic in origin, and proposes to employ a whole genome DNA methylation approach on tissues obtained from familial Chiari I subjects and unaffected controls. While evidence that Chiari I can be inherited continues to accumulate, a unified genetic basis or mode of inheritance has not been identified.

Saliva Sample Tutorial Video – Click here

Title: DNA Methylation in Spina Bifida
Investigator: Dr. Bermans Iskandar, MD and Dr. Reid Alisch, PhD
Sponsor: ICTR Translational Basic & Clinical Pilot Award RFA – University of Wisconsin-Madison

This study hypothesizes that epigenetic modifications contribute to heritable conditions that can be influenced by environmental factors without a change in the DNA sequence. Thus, we believe that alterations in epigenetic modifications cause inherited forms of spina bifida that lack an obvious genetic predisposition but have perceptible links to environmental conditions. Findings from this research will provide critical molecular insights into the heritable basis of these malformations.

Saliva Sample Tutorial Video – Click here

CEREBROVASCULAR / STROKE

Title: Sleep SMART. Sleep for Stroke Management and Recovery Trial
Investigator: Robert J. Dempsey, MD & Jamie Elliott, MD, PhD
Sponsor: National Institutes of Health
ClinicalTrials.gov identifier: NCT03812653
Investigator-initiated, phase 3 multicenter, prospective randomized open, blinded-endpoint controlled trial to test whether treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure is effective for secondary prevention and recovery after stroke.

The University of Wisconsin School of Medicine and Public Health is one of over 100 locations in the U.S. participating in this trial. 

Title: SATURN. Statins Use in Intracerebral Hemorrhage Patients.
Investigator: Azam S. Ahmed, MD
Sponsor: National Institutes of Health
ClinicalTrials.gov: NCT03936361

This is a Multi-Center, pragmatic, prospective, randomized, open-label and blinded-endpoint assessment (PROBE) clinical trial. The purpose of this study is to determine the effects of continuation vs. discontinuation of statins on the risk of ICH recurrence during 24 months of follow-up in patients presenting with a spontaneous lobar ICH while taking a statin drug.

The University of Wisconsin School of Medicine and Public Health is one of over 120 locations in the U.S. participating in this trial.

Title: CAPTIVA: Comparison of Antocoagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Investigator: Dr. Azam S. Ahmed, MD
Sponsor: National Institutes of Health
ClinicalTrials.gov: NCT05047172

A two-stage Phase III trial, double -blinded for patients with stroke within 30 days. Stroke is attributed to 70-99% stenosis of a major intracranial artery.

The University of Wisconsin School of Medicine and Public Health is one of over 150 locations in the U.S. participating in this trial. 

Title: VERIFY: Validation of Early Prognostic Data for Recovery Outcome after Stroke for Future Higher Yield Trials (Verify)
Investigator: Dr. Azam S. Ahmed, MD
Sponsor: National Institutes of Health
ClinicalTrials.gov: NCT05338697

This study will validate biomarkers of upper extremity motor outcome in the acute ischemic stroke window. Inclusion are adult patients enrolled within 48 to 96 hours of acute stroke onset and with motor deficits in the acutely affected upper extremities.

The University of Wisconsin School of Medicine and Public Health is one of over 35 locations in the U.S. participating in this trial. 

Title: The Repeated ASSEssment of SurvivorS in ICH (REASSESS)
Investigator: Dr. Azam S. Ahmed, MD
Sponsor: National Institutes of Health
ClinicalTrials.gov: NCT05611918

This study will conduct long-term cognitive, functional and neuropsychiatric performance assessment to determine if evacuation of spontaneous intracerebral hemorrhage (ICH) reduces the risk of later cognitive decline in the aging brain.

Title: Kaneka Endovascular Embolization and Protection (KEEP) Post Market Study
Investigator: Dr. Azam S. Ahmed, MD
Sponsor: Kaneka Medical LLC.
ClinicalTrials.gov: NCT05563051

The purpose of this study is to evaluate both short- and long-term clinical performance and safety of the commercially available i-ED COILS.

OTHERS

Title: External Ventricular Drain Infections (EVD Consortium)
Investigator: Dr. Azam S. Ahmed, MD
Sponsor: The University of Wisconsin, Department of Neurological Surgery

This stud wants to reduce the rate of infections among patients with external ventricular drains by utilizing a standardized protocol for EVD placement and maintenance.

SPINE

Title: SLIP II Registry
Investigator: Daniel K. Resnick, MD
Sponsor: Lahey Clinic
ClinicalTrials.gov identifier: NCT 03570801

The purpose of this study is to determine the comparative effectiveness of decompression alone versus decompression and fusion for patients with degenerative grade I spondylolisthesis and symptomatic lumbar spinal stenosis.

COMPLETED CLINICAL TRIALS

Title: DEFUSE 3 trial: Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3.
Investigator: Azam S. Ahmed, MD
Co-Investigator: Luke ‘Edward’ Bradbury, MD
Sponsor: National Institutes of Health, coordinating site: Stanford University
ClinicalTrials.gov identifier: NCT02586415

This study is a prospective, randomized, multi-center, Phase III, adaptive design, population enrichment, blinded endpoint, controlled trial. The purpose is to evaluate if endovascular treatment leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-16 hours after stroke onset. The University of Wisconsin School of Medicine and Public Health is one of 45 locations in the U.S. participating in this trial.
Results: http://www.nejm.org/doi/full/10.1056/NEJMoa1713973

Title: The MISTIE III trial: Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III
Investigator: Azam S. Ahmed, MD
Sponsor: John Hopkins University coordinating site, National Institutes of Health
ClinicalTrials.gov identifier: NCT01827046
Website: http://braininjuryoutcomes.com/mistie-iii-about

This study is a Phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of Intracerebral Hemorrhage (ICH). The purpose is to determine the efficacy of using a combination of minimally invasive surgery and clot lysis with rt-PA to remove ICH improves functional outcome. The University of Wisconsin School of Medicine and Public Health is one of over 70 locations worldwide participating in this trial.

Title: North American Spine Society (NASS) Spine Registry Pilot
Investigator: Daniel K. Resnick, MD
Sponsor: North American Spine Society

The main purpose for this pilot registry is research and quality improvement for spine care. The NASS Spine Registry Pilot aims to test registry processes ultimately aimed at collecting data to enhance understanding of spine care treatments and their resulting patient outcomes, as well as examine the natural history of spine disorders. 13 site across the U.S are participating in this Pilot study.

Title: The RISCIS trial: A Multi-Center, Randomized, Placebo-Controlled, Double-Blinded, Trial Efficacy and Safety of Riluzole in Acute Spinal Cord Injury. Phase II/III
Investigator: Nathaniel P. Brooks, MD
Sponsor: AOSpine North America, Sponsor/CRO representative monitoring
ClinicalTrials.gov identifier: NCT01597518
This is an international, multi-center, prospective, double-blinded, randomized, placebo-controlled Phase II/III clinical trial to evaluate if Riluzole at a dose of 100 mg BID for the first 24 hours followed by 50 mg BID for 13 days is superior to placebo in subjects with acute traumatic Spinal Cord Injury (SCI).
The study will involve up to 35 investigational sites and enroll 351 subjects (includes 10% allowance for attrition).

Title: Chiari Surgery Outcomes Study
Investigator: Bermans J. Iskandar, MD
Study Sponsor: American Syringomyelia and Chiari Alliance Project Inc.

A research project collecting pilot data to evaluate surgical approaches and outcomes in surgery for patients with Chiari type I malformation and Syringomyelia. The study will collect data on the characteristics of subjects who ultimately undergo surgical intervention. Dr. Iskandar and the University of Wisconsin School of Medicine and Public Health will be the coordinating center collecting and compiling data from 12 clinical sites across the United States.

Title: The Park-Reeves Syringomyelia Research Consortium (PRSRCC) Study
Investigator: Bermans J. Iskandar, MD
Study Sponsor: The Park Reeves Syringomyelia Research Consortium
Website: https://park-reeves.wustl.edu/

The purpose of this study is to create the Park Reeves Syringomyelia Registry, a multi-institutional, online, comprehensive database to collect and store prospective and retrospective data regarding Chiari I Malformations and Syringomyelia. Results from this study will help better understand the pathogenesis of Syringomyelia and how best to treat it as well as answer long-standing questions regarding the optimal surgical techniques for Chiari Malformation. The University of Wisconsin School of Medicine and Public Health and the American Family Children’s Hospital are one of more than 30 clinical sites across the United States participating in this study.

Title: CSM-S Trial: Cervical Spondylotic Myelopathy Surgical Trial
Investigator: Daniel K. Resnick, MD
Sponsor: Patient-Centered Outcomes Research Institute (PCORI), Lahey Clinic
ClinicalTrials.gov identifier: NCT02076113

The purpose of the study is to determine the optimal surgical approach (ventral vs dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM). There are no established guidelines for the management of patients with CSM, which represents the most common cause of spinal cord injury and dysfunction in the US and in the world. The University of Wisconsin School of Medicine and Public Health is one of over 15 locations in the U.S. participating in this trial.

Title: Neural Networks in Epilepsy. Neural Network Analysis in Childhood Onset Epilepsy.
Investigator: Dr. Raheel Ahmed, MD, PhD
Sponsor: ICTR. Institute for Clinical and Translational Research – University of Wisconsin

This study wants to assess the underlying neural networks in childhood epilepsy. A total of 5 sites are participating in this study and the University of Wisconsin, Department of Neurological Surgery is the coordinating center.

Title: ARCADIA trial: Atrial Cardiopathy and Antithrombotic Drugs in Prevention after Cryptogenic Stroke
Investigator: Luke Bradbury, MD & Azam S. Ahmed, MD
Sponsor: National Institutes of Health
ClinicalTrials.gov identifier: NCT03192215

This is a multi-center, biomarker-driven, randomized, double-blinded, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknow cause. The University of Wisconsin School of Medicine and Public Health is one of over 120 locations in the U.S. participating in this trial.

Title: ARCADIA-CSI: Cognition and Silent Infarcts
Investigator: Luke Bradbury, MD
Sponsor: National Institutes of Health

ARCADIA-CSI is an ancillary study to the ARCADIA trial that will add two outcomes (cognition and silent infarction) to the parent trial. The purpose of ARCADIA-CSI is to determine the effect of apixaban vs aspirin on these two additional outcomes in patients with stroke of unknown cause and atrial cardiopathy. The University of Wisconsin School of Medicine and Public Health is one of over 120 locations in the U.S. participating in this trial.

Title: NIRS. Near Infrared Spectroscopy for early detection of cerebral vasospasm in patients with subarachnoid hemorrhage
Investigator: Dr. Azam S. Ahmed, MD
Sponsor: The University of Wisconsin, Department of Neurological Surgery.

The novelty of this study is to investigate an existing technology for sensitivity in detecting ischemia within the cerebral cortex in patients with aneurysmal subarachnoid hemorrhage.

Title: MRgLITT Registry. MRI guided laser interstitial thermal therapy Registry
Investigator: Dr. Raheel Ahmed, MD, PhD
Sponsor: Hospital for Sick Children – Toronto (Canada)

The goal of this project is to compare the effectiveness of two treatment strategies in children with medically intractable Epilepsy. The University of Wisconsin School of Medicine and Public Health and the American Family Children’s Hospital is one of 10 sites in the Unites States and Canada participating in this project.

Title: NITE 1: Feasibility Study of the treatment of Acute Ischemic Stroke using the NOVIS Transcarotid Neuroprotection System in Transcarotid Embolectomy
Investigator: Dr. Azam  S. Ahmed, MD
Sponsor: Silk Road Medical 

A prospective, multi-center, single arm feasibility study for the endovascular treatment of patients with acute ischemic anterior circulation strokes due to large vessel embolic occlusions using the transcarotid approach with flow reversal. Patients enrolled into the NITE 1 Study will have failed transfemoral therapy and will be followed immediately from post-op to 90 days.

Title: Posterior Fossa Decompression with or without Duraplasty for Chiari type I Malformation with Syringomyelia
Investigator: Bermans J. Iskandar, MD
Study Sponsor: PCORI (Patient-Centered Outcomes Research Institute)

Chiari type I malformation and Syringomyelia is treated with neurosurgical decompression of the craniocerebral junction with either of two technical variations: posterior fossa decompression with duraplasty (PFDD) or posterior fossa decompression without duraplasty (PFD) The Hypothesis of this study is that PFD will be associated with fewer surgical complications and less harm to patients that PFDD. The University of Wisconsin School of Medicine and Public Health and the American Family Children’s Hospital are one of 47 clinical sites across the United States participating in this study.

Title: I-ACQUIRE
Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
Site Principal Investigator: Bernadette Gillick, PhD, MSPT, PT (University of Wisconsin-Madison)
Co-PI: Dr. Robert Dempsey, MD (University of Wisconsin-Madison)
Protocol Principal Investigators: Dr. Sharon Ramey (Roanoke, VA) and Dr. Warren Lo (Columbus, OH)
Sponsor: National Institutes of Health
Clinicaltrials.gov identifier: NCT03910075

I-ACQUIRE is a specific form of pediatric constraint induced movement therapy and has been shown to be effective in children with hemiplegia. This study compares two doses of I-ACQUIRE treatment to typical rehabilitation (physical and/or occupational therapy) treatment in children (ages 8 months-36 months) with hemiplegia due to Perinatal Arterial Stroke (PAS). The goal is to find the amount of I-ACQUIRE therapy that helps the child gain the most arm and hand use. Thirteen treatment sites are located throughout the United States of America.

Title: Structural Stability of Carotid Plaque and Symptomatology
Investigator: Robert J. Dempsey, MD
Sponsor: National Institutes of Health
ClinicalTrials.gov identifier: NCT02476396
Enrollment completed, data analysis ongoing
A research project looking at the differences in the plaque in people with symptomatic and asymptomatic carotid stenosis (narrowing of the carotid arteries). The study uses various techniques to look at the differences in people who have carotid stenosis and the causes and consequences of carotid stroke.

Title: C-Arm Cone Beam CTP Guided Interventions for Treatment of Cerebral Ischemia
Investigator: Dr. Beverly Aagaard-Kienitz, MD
Sponsor: National Institutes of Health

The overarching objective of our proposal is to develop a One-Stop-Shop imaging using the available C-arm cone-beam CT (C-arm CBCT) data acquisition systems currently widely available worldwide in interventional angiography suites to enable acute ischemic stroke patients to be imaged, triaged, treated, and assessed using a single modality in one room.