University of Wisconsin–Madison
Clinical Trials

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: 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: 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: 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: 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: 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.

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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.

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CEREBROVASCULAR / STROKE

Title: Structural Stability of Carotid Plaque and Symptomatology
Investigator: Robert J. Dempsey, MD
Sponsor: National Institutes of Health
ClinicalTrials.gov identifier: NCT02476396

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: 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: 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: 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.

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. 

OTHERS

Title: External Ventricular Drain Infections (EVD Consortium)
Investigator: Dr. Joshua Medow, MD, PhD
Sponsor: The University of Wisconsin, Department of Neurological Surgery

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

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.

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.

nih strokenet logo NIH StrokeNet What is StrokeNet? In September of 2013, the National Institutes of Health (NIH) funded the stroke trials network, NIH StrokeNet. StrokeNet is an infrastructure of 25 Regional Coordinating Centers across the U.S., a National Coordinating Center at the University of Cincinnati, and a National Data Management Center (Medical University of South Carolina). The primary goal of this network is to maximize efficiencies to develop, promote and conduct high-quality, large and small, multi-site clinical trials and research studies focused on key interventions in stroke prevention, treatment and recovery. This network which involves more than 200 hospitals is designed to serve as the infrastructure and pipeline for new potential treatments for patients with stroke and those at risk for stroke, as well as an educational platform for stroke physicians and clinical trial coordinators. The University of Wisconsin-Madison is one of 25 Regional Coordinating Center that works with various hospitals throughout Wisconsin and northern Illinois. For additional information, please visit www.nihstrokenet.org The University of Wisconsin Regional Coordinating Center for Stroke Research – UWRCC24 The University of Wisconsin Hospital & Clinics Department of Neurological Surgery 600 Highland Avenue Madison, Wisconsin 53792-8660 Principal Investigator Robert J. Dempsey MD Chairman and Manucher J. Javid Professor of Neurological Surgery Director of Comprehensive Stroke Center (608) 265-5967 dempsey@neurosurgery.wisc.edu Co-Investigator Azam S. Ahmed MD Associate Professor of Neurological Surgery and Radiology (608) 263-1410 azam.ahmed@neurosurgery.wisc.edu Research Program Manager & Educational/Training Contact Stephanie M. Wilbrand, PhD Clinical Research Manager in Neurological Surgery (608) 265-9248 wilbrand@neurosurgery.wisc.edu Clinical Research Coordinators Jenna Bock Associate Research Specialist in Neurological Surgery (608) 261-1577 bock@neurosurgery.wisc.edu Thomas Staniszewski Associate Research Specialist in Neurological Surgery (608) 262-6493 staniszewski@neurosurgery.wisc.edu Cedric Williams Associate Research Specialist in Neurological Surgery (608) 262-7481 cwilliams@neurosurgery.wisc.edu Andrea Strayer, NP NP/Research Nurse in Neurological Surgery (608) 2262-8633 strayer@neurosurgery.wisc.edu Past Fellows: 2017-2018    Ignasius Esene, MD/PhD (Medical Practice Cameroon) 2016-2017    Sepideh Chagharvand, MD (University of Wisconsin-Madison 2015-2016    Kyle I Swanson MD (Barrow Neurological Institute) 2014-2015    Christopher Baggott MD (University of Wisconsin-Madison) 2013-2014    Patel Biraj MD (Virginia Tech Carilion School of Medicine) Collaborators

  • Beverly Aagaard-Kienitz MD (Professor Radiology and Neurological Surgery at the University of Wisconsin-Madison).
  • Mustafa K. Baskaya MD (Professor Neurological Surgery & Director Skull Base Program at the University of Wisconsin-Madison).
  • Edward “Luke” Bradbury MD (Associate Professor Neurology at the University of Wisconsin-Madison).
  • Bermans J. Iskandar MD (Professor Neurological Surgery & Director Pediatric Neurosurgery at the University of Wisconsin-Madison).
  • Joshua E. Medow MD (Associate Professor Neurological Surgery at the University of Wisconsin-Madison).
  • David B. Niemann MD (Associate Professor Department of Neurological Surgery and Radiology at the University of Wisconsin-Madison).
  • Justin A. Sattin MD (Associate Professor Neurology at the University of Wisconsin-Madison).
  • Raghu Vemuganti PhD (Professor Neurological Surgery at the University of Wisconsin-Madison).
  • Umadevi Wesley, PhD (Distinguished Research Professor Neurological Surgery at the University of Wisconsin-Madison)
  • Jamie Elliott, MD, PhD (Assistant Professor Neurology at the University of Wisconsin-Madison)
  • Eric Adelman, MD (Associate Professor Neurology at the University of Wisconsin-Madison)
  • Nathalie Wheeler, MD (Assistant Professor Neurology at the University of Wisconsin-Madison)
  • Erick Tarula, MD (Assistant Professor Neurology at the University of Wisconsin-Madison)
  • Marcus Chacon, MD (Associate Professor of Neurology at the University of Wisconsin-Madison)
  • Jerdan Ruff, MD (Assistant Professor of Neurology at the University of Wisonsin-Madison)

Affiliated Satellites •    Aurora Health Care www.aurorahealthcare.org •    Alexian Brothers Health System www.alexianbrothershealth.org •    Marshfield Clinic www.marshfieldresearch.org •    Gundersen Health System www.gundersenhealth.org •    Ho-Chunk House of Wellness www.health.ho-chunk.com •    Meriter Hospital www.meriter.com •    Swedish American Health www.swedishamerican.org For more information, please visit: http://nihstrokenet.org/the-network/about-us/wisconsin

STROKE PREVENTION IN THE WISCONSIN NATIVE AMERICAN POPULATION – THE ONEIDA NATION ClinicalTrials.gov: NCT04382963 Sponsors: Wisconsin Partnership Program, The University of Wisconsin-Madison, and the Department of Neurological Surgery Investigator: Dr. Robert J. Dempsey, MD Co-Investigator: Dr. Carol C. Mitchell, PhD Tribal Advisors: Dr. Ravinder Vir, MD and Deborah Danforth – Oneida Nation Research Program Manager: Dr. Stephanie Wilbrand, PhD

Oneida Picture 1                                        Oneida Picture 2

The Oneida Comprehensive Health Division and the University of Wisconsin-Madison have initiated a partnership to decrease stroke and stroke risk factors in the Oneida Nation through an Educational and Clinical Research Program. Stroke Awareness Team:  A Partnership between the University of Wisconsin-Madison Department of Neurosurgery and the Oneida Comprehensive Health Division The University of Wisconsin-Madison Department of Neurosurgery and the Oneida Comprehensive Health Division have created a partnership to provide information to the Oneida community about the signs and symptoms of stroke.  One of the key factors for preventing stroke is for individuals to understand the risk factors for stroke and how to modify their risk factors to decrease their risk for stroke.  This is important in the Native American community, as Native Americans are considered to be at higher risk for stroke. For more information: https://oneidastrokeprogram.wisc.edu/

2021

NIH StrokeNet Biweekly Update 26-March 2021.pdf
NIH StrokeNet Biweekly Update 12-March 2021.pdf
NIH StrokeNet Biweekly Update 12-Feb 2021.pdf
NIH StrokeNet Biweekly Update 29-Jan 2021.pdf
NIH StrokeNet Biweekly Update 15-Jan 2021.pdf

2020

NIH StrokeNet Biweekly Update 4-Dec 2020.pdf
NIH StrokeNet Biweekly Update 20-Nov 2020.pdf
NIH StrokeNet Biweekly Update 6-Nov 2020.pdf
NIH StrokeNet Biweekly Update 23-Oct 2020.pdf
NIH StrokeNet Biweekly Update 9-Oct 2020.pdf
NIH StrokeNet Biweekly Update 25-Sep 2020.pdf
NIH StrokeNet Biweekly Update 11-Sep 2020.pdf
NIH StrokeNet Biweekly Update 14-August 2020.pdf
NIH StrokeNet Biweekly Update 31-July 20.pdf
NIH StrokeNet Biweekly Update 3-July 2020.pdf
NIH StrokeNet Biweekly Update 19-June 2020 v2.pdf
NIH StrokeNet Biweekly Update 5-June 2020 v2.pdf
NIH StrokeNet Biweekly Update 22-May 2020.pdf
NIH StrokeNet Biweekly Update 8-May 2020.pdf
NIH StrokeNet Biweekly Update 24-April 2020.pdf
NIH StrokeNet Biweekly Update 10-April 2020.pdf
NIH StrokeNet Biweekly Update 27-March 2020.pdf
NIH StrokeNet Biweekly Update 13-March 2020 v2.pdf
NIH StrokeNet Biweekly Update 28-February 2020.pdf
NIH StrokeNet Biweekly Update 14-February 2020.pdf
NIH StrokeNet Biweekly Update 31-January 2020.pdf
NIH StrokeNet Biweekly Update 17-January 2020.pdf

2019

NIH StrokeNet Biweekly Update 20-Dec 2019.pdf
NIH StrokeNet Biweekly Update 6-Dec 2019.pdf
NIH StrokeNet Biweekly Update 22-November 2019.pdf
NIH StrokeNet Biweekly Update 8-November 2019.pdf
UW RCC24 – October 2019 Newsletter.pdf
UW RCC24 – September 2019 Newsletter.pdf
UW RCC24 – August 2019 Newsletter.pdf
UW RCC24 – July 2019 Newsletter.pdf
UW RCC24 – June 2019 Newsletter.pdf
UW RCC24 – May 2019 Newsletter.pdf
UW RCC24 – April 2019 Newsletter.pdf
UW RCC24 – March 2019 Newsletter.pdf
UW RCC24 – February 2019 Newsletter.pdf
UW RCC24 – January 2019 Newsletter.pdf

2018

UW RCC24 – December 2018 Newsletter.pdf
UW RCC24 – November 2018 Newsletter.pdf
UW RCC24 – October 2018 Newsletter.pdf
UW RCC24 – September 2018 Newsletter.pdf
UW RCC24 – August 2018 Newsletter.pdf
UW RCC24 – July 2018 Newsletter.pdf
UW RCC24 – June 2018 Newsletter.pdf
UW RCC24 – May 2018 Newsletter.pdf
UW RCC24 – April 2018 Newsletter.pdf
UW RCC24 – March 2018 Newsletter.pdf
UW RCC24 – February 2018 Newsletter.pdf
UW RCC24 – January 2018 Newsletter.pdf

2017

UW RCC24 – December 2017 Newsletter.pdf
UW-RCC24 – November 2017 – Newsletter.pdf
UW-RCC24 – October 2017 – Newsletter.pdf
UW-RCC24 – September 2017 – Newsletter.pdf
UW-RCC24 – August 2017 – Newsletter.pdf
UW RCC24 – July 2017 Newsletter.pdf
UW-RCC24 – June 2017 – Newletter.pdf
UW-RCC24 – May 2017 – Newsletter.pdf
UW-RCC24 – April 2017 – Newsletter.pdf
UW-RCC24 – March 2017 – Newsletter.pdf
UW-RCC24 – February 2017 – Newsletter.pdf
UW RCC24 – January 2017 Newsletter.pdf