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:
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Spine
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Vascular, including arterial venous malformation and brain aneurysm
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Brain tumors
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Neurological disorders, such as Parkinson's, dystonia, and epilepsy
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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 #: Pro00108983
Short title: Gene therapy study
CT.gov: https://clinicaltrials.gov/ct2/show/NCT04903288
CT.gov Identifier: NCT04903288
Brief Summary:This study will have a trial phase and an extension phase. The primary objective of the trial phase is to assess the safety of the SmartFlow® MR Compatible Ventricular Cannula for administering eladocagene exuparvovec to pediatric participants with aromatic L-amino acid decarboxylase (AADC) deficiency. The extension phase is designed to capture additional clinical information for eladocagene exuparvovec, including changes in motor development, AADC-specific symptoms, and other pharmacodynamic (PD) measures.
PI: Dr. Matthew Vestal
Sub-I: Dr. Muhammad Zafar
Study Coordinator: Claudia Pamanes
Sponsor: PTC Therapeutics
Protocol #: Pro00108630
Study Name (Short Title): Mainstay RESTORE RCT
Brief Description of Study: ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation (RESTORE)
NCT # (the clinicaltrials.gov registry number): NCT04803214
Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04803214?term=mainstay+restore&draw=2&rank=2
PI Name: Nandan Lad, MD, PhD & Christopher Brown, MD
Lead CRC Name: Allison W. Spell, CCRP
Protocol #: Pro00109334
Study Name (Short Title): REMASTer
Brief Description of Study: This is a randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of radiographic progression evidence after stereotactic radiosurgery (SRS), with or without resection.
NCT # (the clinicaltrials.gov registry number): NCT05124912
Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT05124912?term=NCT05124912&draw=2&rank=1
PI Name: Dr. Peter Fecci, MD, PhD
Lead CRC Name: Anna Thirakul, CCRP
Protocol #: Pro00110138 (pending IRB approval)
Study Name (Short Title): Ferritin and Iron burden in SAH sIRB
Brief Description of Study: This is a Phase I/IIA, multi-center, randomized, double blinded, Placebo vs. Deferiprone, where subjects will be recruited and randomized 1:1 to receive deferiprone or placebo. Sixty-six (66) adult subjects are planned to be enrolled with 10 alternate subjects who will be recruited to replace those that screen fail, drop out, or are removed from the study. We will recruit men and non-pregnant women of any ethnic background between the age ≥ 18 and ≤ 75 years that have ruptured intracranial aneurysm causing SAH and intraventricular hemorrhage (IVH) requiring placement of an external ventricular drain (EVD).
NCT # (the clinicaltrials.gov registry number): NCT03754725
Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/record/NCT03754725?term=Ferritin&cond=Subarachnoid+Hemorrhage&draw=2&rank=2
PI: Dr. David Hasan
Lead CRC: Anna Thirakul
Protocol #: Pro00108759
Study Name (Short Title): Neurona
Brief Description of Study: This study is designed in two stages to evaluate the safety (Stage 1 and Stage 2) and efficacy (Stage 2) of NRTX-1001 in participants with drug resistant mesial temporal lobe epilepsy (MTLE). In Stage 1, participants will have surgical treatment with NRTX-1001. In Stage 2, participants will be randomized to either surgical treatment with NRTX-1001 or to a sham surgery (which is surgery that omits the placement of Investigational Cells) in combination with ongoing medical management.
NCT # (the clinicaltrials.gov registry number): NCT05135091
Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT05135091?term=neurona&draw=2&rank=1
PI Name: Derek Southwell, MD, PhD
Lead CRC Name: Jodi Lennon
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: Peter Fecci, MD, PhD
Lead CRC: 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: Muhammad Abd-El-Barr, MD, PhD
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
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