Clinical Trials

The Duke Department of Neurosurgery is actively involved in clinical research to improve treatment options for patients at Duke and around the world. Our extensive research programs give our patients access to groundbreaking developments in patient care through carefully designed clinical trials.

We conduct clinical trials in the following areas:

  • Spine

  • Vascular, including arterial venous malformation and brain aneurysm

  • Brain tumors

  • Neurological disorders, such as Parkinson's, dystonia, and epilepsy

  • Pediatric brain tumor and injury

 

For Researchers

Clinical Research Units (CRU) provide the organizing structure for the conduct of any research in the School of Medicine in which a Duke faculty member is responsible for the involvement of human subjects. The CRU is the operating and business unit responsible for the integrity, financial accountability, regulatory compliance, quality, and academic productivity of this research activity. All research projects involving human subjects should be conducted within the Neurosurgery CRU. To initiate a research proposal first complete this intake form. For assistance, please contact the Neurosurgery CRU oversight team.

 

Current Trials

Protocol #: Pro00071347

Study Name (Short Title): LAANTERN

Brief Description of Study: A prospective registry for patients receiving laser interstitial thermal therapy (LITT) for abnormal neurological tissue (brain lesions or epilepsy)

NCT # (the clinicaltrials.gov registry number): NCT02392078

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02392078?term=LAANTERN&draw=2&rank=1

PI Name: Peter Fecci, MD, PhD

Lead CRC Name: Courtney E. Wimberly, MS

 

Protocol #: Pro00104955

Study Name (Short Title): SPR LBP RCT

Brief Description of Study: a comparison of SPRINT PNS (peripheral nerve stimulation) to standard interventional management for the treatment of chronic low back pain

NCT # (the clinicaltrials.gov registry number): NCT04246281

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04246281?term=sprint+pns&draw=2&rank=5

PI Name: Thomas Hopkins, MD, MBA

Lead CRC Name: Allison Spell, CCRP

 

Protocol #: Pro00106693

Study Name (Short Title): Saluda ECAP Study

Brief Description of Study:

NCT # (the clinicaltrials.gov registry number): NCT04319887

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT04319887?term=NCT04319887&draw=2&rank=1

PI Name: Nandan Lad, MD, PhD

Lead CRC Name: Allison Spell, CCRP

 

Protocol #: Pro00106738

Study Name (Short Title): SCS for SCI

Brief Description of Study: Spinal Cord Stimulation for Spinal Cord Injury

NCT # (the clinicaltrials.gov registry number): NCT04894734

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04894734?term=NCT04894734&draw=2&rank=1

PI Name: Nandan Lad, MD, PhD

Lead CRC Name: Allison Spell, CCRP

 

Protocol #: Pro00105872

Study Name (Short Title): Perioperative Evaluation of Cerebellar Tumors

Brief Description of Study: Impact of Cerebellar Functional Topography on Cognition and Motor Ataxia

ClinicalTrials.gov Identifier: NCT04463979

Clinicaltrials.gov link:  

https://clinicaltrials.gov/ct2/show/NCT04463979

PI: Allan Friedman, MD

Lead CRC Name: Claudia Pamanes, MPH

 

Pro00103904

Study Name (Short Title): The NOTICE Study

Brief Description of Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions

ClinicalTrials.gov Identifier: NCT04140344 https://clinicaltrials.gov/ct2/show/record/NCT04140344

PI: Oren Gottfried, MD

Lead CRC Name: Claudia Pamanes, MPH

 

Protocol #: Pro00090455

Study Name (Short Title): Cerapedics P-15L

Brief Description of Study: An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion with Instrumentation

NCT # (the clinicaltrials.gov registry number): NCT03438747

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT03947541?term=karikari&draw=2&rank=2

PI Name: Isaac Karikari, MD

Lead CRC Name: Alexia Bwensa

 

Protocol #: Pro00101198

Study Name (Short Title): DSOS

Brief Description of Study: A comprehensive, retrospective & prospective clinical registry collecting diagnostic & treatment variables along with disease specific & generic health related quality of life data & clinical specimens on treated patients with illnesses of the spine. 

NCT # (the clinicaltrials.gov registry number): NCT04217525

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04217525?term=courtney+goodwin&draw=2&rank=1

PI Name: C. Rory Goodwin, MD, PhD

Lead CRC Name: Alexia Bwensa

 

Protocol #: Pro00105200

Study Name (Short Title): Stryker Adherus Dural Sealant Trial

Brief Description of Study: The Study purpose is to demonstrate that Adherus Dural Sealant is safe and effective at achieving water-tight closure when used as an adjunct to standard methods of dural repair for spinal procedures as compared to DuraSeal Exact. Adherus Dural Sealant is intended as an adjunct to standard methods of dural repair, such as sutures, to provide watertight closure during spinal procedures.

NCT # (the clinicaltrials.gov registry number): NCT04498026

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04498026?term=stryker+adherus&draw=2&rank=1

PI Name: C. Rory Goodwin, MD, PhD

Lead CRC Name: Alexia Bwensa

 

Protocol #: Pro00102543

Study Name (Short Title): MTRON

Brief Description of Study: Metastatic Tumor Research and Outcomes Network

NCT # (the clinicaltrials.gov registry number): NCT02830451

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02830451  

PI Name: C. Rory Goodwin, MD, PhD

Lead CRC Name: Alexia Bwensa

 

Protocol #: Pro00102223

Study Name (Short Title): PCD2

Brief Description of Study: Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal deformity.

NCT # (the clinicaltrials.gov registry number): NCT04194996

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04194996?term=PCD2&draw=2&rank=1

PI Name: Christopher Shaffrey, MD

Lead CRC Name: Joshua Hoover, MS

 

Protocol #: Pro00102237

Study Name (Short Title): Globus

Brief Description of Study: The purpose of this study is to prospectively review outcomes of patients who have surgery with the ExcelsiusGPS™ robotics system in order to analyze screw placement accuracy. Patient demographics, intraoperative data and radiographic imaging to determine screw placement accuracy will be collected and reviewed. This information will be compared in a separate study to retrospectively collected data from sites who have done a similar number of cases without the robot.

NCT # (the clinicaltrials.gov registry number): NCT04257279

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04257279?term=GLOBUS+ROBOTICS&draw=2&rank=1#contacts

PI Name: Phillip Horne, MD, PhD

Lead CRC Name: Joshua Hoover, MS

 

Protocol #: Pro00074235

Study Name (Short Title): Temporal Patterns of Deep Brain Stimulation

Brief Description of Study: This study measures the effects of non-regular temporal patterns of deep brain stimulation on motor symptoms and neural activity in persons with Parkinson's disease or essential tremor.

NCT # (the clinicaltrials.gov registry number): NCT02553525

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02553525?term=NCT02553525&draw=2&rank=1

PI Name: Warren Grill, PhD

Lead CRC Name: Jennifer Peters

 

Protocol #: Pro00065476

Study Name (Short Title): Network Dynamics of Human Cortical Processing

Brief Description of Study: The goal of this study is to elucidate the network dynamics among brain regions that give rise to cognitive faculties (language, decision making, and memory) in humans.

NCT # (the clinicaltrials.gov registry number): N/A

Clinicaltrials.gov link: N/A

PI Name: Gregory Cogan, PhD

Lead CRC Name: Anna Thirakul

 

Protocol #: Pro00072892

Study Name (Short Title): Studying human cognition and neurological disorders using µECoG electrodes

Brief Description of Study: The purpose of this study is to observe the signals inside of the brain that are responsible for human behavior, such as language, memory, and decision making. The study will use an investigational device, called a micro-ECoG array to record signals from the brain.

NCT # (the clinicaltrials.gov registry number): N/A

Clinicaltrials.gov link: N/A

PI Name: Gregory Cogan, PhD

Lead CRC Name: Anna Thirakul

 

Protocol #: Pro00107571 

Study Name (Short Title): NuVasive CIB Study

Brief Description of Study: This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of select interbody implant devices in patients who undergo interbody fusion surgery of the cervical spine. Safety and performance will be measured by reported complications, radiographic outcomes, and PROs. This study is being undertaken to identify possible residual risks and to clarify mid- to long-term clinical performance that may affect the benefit/risk ratios of these interbody implants.

NCT # (the clinicaltrials.gov registry number): NCT04689854

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04689854?term=NCT04689854&draw=2&rank=1

PI Name: Michael Haglund, MD

Lead CRC Name: Joshua Hoover, MS

 

Protocol #: Pro00103019

Study Name (Short Title): Tissue Explant Study

Brief Description of Study: The purpose of this study is to collect brain tissue that is removed during epilepsy surgery. During the surgery, a portion of brain tissue is collected and sent to pathology for diagnostic purposes. After a portion of the brain tissue is used for pathology, excess tissue is typically discarded. For this study, Dr. Southwell wishes to use the remaining brain tissue for future research. The leftover brain tissue will be used to create a system to help scientists gain a better understanding of the causes of epilepsy as well as its treatment.

NCT # (the clinicaltrials.gov registry number): N/A

Clinicaltrials.gov link: N/A

PI Name: Derek Southwell, MD, PhD

Lead CRC Name: Jodi Lennon, RN, BSN

 

Protocol #: Pro00104765

Study Name (Short Title): NuVasive Lumbar Interbody Study

Brief Description of Study: This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of select interbody implant devices in patients who undergo interbody fusion surgery. Consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with degenerative conditions in the thoracic and/or lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled into the study, subjects will undergo interbody fusion surgery using one of the NuVasive interbody implant groups based on the surgeon's standard of care.

NCT # (the clinicaltrials.gov registry number): NCT04418830

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04418830?term=nct04418830&draw=2&...

PI Name: Khoi Than, MD, PhD

Lead CRC Name: Anna Thirakul

 

Protocol #:  Pro00103091

Study Name (Short Title):  SDIM - Spinal Deformity Intraoperative Monitoring: Understanding and managing intraoperative neuromonitoring changes during spinal deformity surgery: a prospective interventional study (SDIM)

Brief Description of Study:  A multicenter, international prospectively collected patient cohort undergoing high-risk spinal cord level surgery or spinal osteotomy procedures will be enrolled to establish the incidence of intraoperative alerts in high-risk spinal cord cases, and explore factors associated with mitigating injury.

NCT # (the clinicaltrials.gov registry number):  NCT03880292

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT03880292?term=SDIM&draw=2&rank=1

PI Name: Christoper Shaffrey, MD

Lead CRC Name: Karen Grace, RN, BSN, CCRC

 

Protocol #: Pro00103629

Study Name (Short Title): NACTN Spinal Cord Injury Registry

Brief Description of Study: The NACTN Spinal Cord Injury Registry is a network of clinical centers collecting de-identified data from patients admitted through the Emergency Department of a NACTN center at the time of injury with an initial (first time) spinal cord injury (SCI). Information will be collected on the natural history of SCI and course of treatment through the first 12 months from the date of injury or long as medically indicated. Data collected includes imaging information from CT or MRI scans, neurological and general medical outcome and rehabilitation evaluation. No intervention is given other than standard of care for spinal cord injury, intensive monitoring and frequent follow up care.

NCT # (the clinicaltrials.gov registry number):  NCT00178724

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00178724?term=NACTN&draw=2&rank=1

PI Name: Christopher Shaffrey, MD

Lead CRC Name: Karen Grace, RN, BSN, CCRC

 

Protocol #: Pro00104811

Study Name (Short Title): (ABBVIE M16-077)

A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Traumatic Cervical Spinal Cord Injury

Brief Description of Study: The purpose of this study is to see if elezanumab is safe and assess change in Upper Extremity Motor Score (UEMS) in participants with acute traumatic cervical SCI.

NCT # (the clinicaltrials.gov registry number): NCT04295538

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04295538?term=ABBVIE+M16-077&draw...

PI Name: Muhammad Abd-El-Barr, MD, PhD

Lead CRC Name: Karen Grace, RN, BSN, CCRC

 

Protocol #: Pro00103857

Study Name (Short Title): (SILVIA) SIJ Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial

Brief Description of Study: This is a multicenter randomized controlled, postmarket clinical study to determine the differences between subjects undergoing standard MLF surgery with S2AI fixation in the pelvis vs the additional placement of iFuse 3-D in the bedrock configuration during MLF surgery. Subjects will be monitored for sacroiliac (SI) joint pain and at two years post surgery a CT scan will be taken to assess S2AI screw loosening or any other findings.

NCT # (the clinicaltrials.gov registry number): NCT04062630

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04062630?term=SILVIA&draw=2&rank=1

PI Name: Khoi Than, MD, PhD

Lead CRC Name:  Karen Grace, RN, BSN, CCRC