University of Wisconsin–Madison
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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:
PHONE:
Office of Clinical Trials 608-265-6507 ctrials@clinicaltrials.wisc.edu

ONLINE:
www.clinicaltrials.gov

BRAIN TUMOR
Please Visit:
Carbone Cancer Center Clinical Trials
Brain/Central Nervous System Clinical Trials

PEDIATRICS

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: 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 decompressin of the cranioverebral 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.

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 patietns who have evidence of atrialc ardipathy 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: MOST trial: Multi-arm Optimization of Stroke Thrombolysis
Investigator: Azam S. Ahmed, MD and Luke Bradbury, MD
Sponsor: National Institutes of Health
ClinicalTrials.gov identifier: NCT03735979
This is a three-arm, adaptive, Phase-3, blinded, randomized controlled clinical trial at approximately 110 sites in the United States, with the University of Wisconsin School of Medicine and Public Health being one of the participating sites.

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.

SPINE

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: 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: 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
Assistant 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
Stephanie Armstrong
Associate Research Specialist in Neurological Surgery
(608) 262-6493
armstrong@neurosurgery.wisc.edu

Victoria Harms
Associate Research Specialist in Neurological Surgery
(608) 262-7481
harms@neurosurgery.wisc.edu

Jenna Bock
Associate Research Specialist in Neurological Surgery
(608) 261-1577
bock@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 (Associate Professor Radiology and Neurological Surgery at the University of Wisconsin-Madison).
  • Mustafa K. Baskaya MD (Associate Professor Neurological Surgery & Director Skull Base Program at the University of Wisconsin-Madison).
  • Edward “Luke” Bradbury MD (Assistant 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 (Assistant 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 (Associate Professor Neurological Surgery at the University of Wisconsin-Madison).
  • Umadevi Wesley, PhD (research Professor Neurological Surgery at the University of Wisconsin-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