Clinical Trials | Duke Department of Neurosurgery

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

updated December 10, 2024

Key Longitudinal Associations with Risk and Glioblastoma Outcomes

IRB Number: Pro00114859

Short title: Key LARGO

PI: Kyle M. Walsh, PhD

Collaborators: Quinn Ostrom, PhD

Study Coordinator: Courtney E. Wimberly (GBMsurvey@duke.edu)

Sponsor: Glioblastoma Research Organization and StacheStrong

Status: Enrolling

Accrual goal: 200

CT.gov link to study: https://clinicaltrials.gov/study/NCT06625684

CT.gov Identifier: NCT06625684

Brief Summary: This observational study aims to investigate the various factors influencing outcomes and risks in adults diagnosed with glioblastoma (GBM). Glioblastoma is a highly aggressive and malignant brain tumor, and understanding the factors that affect patient outcomes is crucial for improving management strategies and patient care.

The main questions the study aims to answer are

How do genetic and immune system factors impact survival and quality of life in GBM patients?
What occupational and medical history factors are linked to the risk of getting GBM?

Participants fill out an online survey about their medical history and lifestyle.

Participants will have the chance to give a blood sample (from the outer arm) up to two times during the study for genetic and immune system testing. Tests are for research only. Blood samples will be given using a home collection kit provided by the study team.

Eligibility: Eligible participants are adults aged 18 and older with a confirmed diagnosis of glioblastoma who read English or Spanish. The study aims to include a diverse population to ensure the findings are broadly applicable.

Post-Market Surveillance Study to Evaluate The Long-Term Safety and Effectiveness of the WEB Device

Protocol Number: Pro00114139

Short title: WEB PAS Study

PI: Erik F. Hauck, MD

Sub-I: David Hasan, MD

Study Coordinator: Amayrani Calvario Salgado

Sponsor: Microvention

Status: Open

Accrual goal: 12

CT.gov link to study: https://clinicaltrials.gov/study/NCT04839705?cond=NCT04839705&rank=1

CT.gov Identifier: NCT04839705

Brief Summary: A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

A Phase 2, multicenter, double-blind, randomized, placebocontrolled, study to assess the safety of amantadine hydrocholoride (HCl) intravenous (IV) solution (MR-301), 50 mg/mL, in patients with severe traumatic brain injury (TBI)

Protocol Number: Pro00115049

Short Title: Shinkei TBI Study

Brief Summary: The objective of this study is to assess the safety and tolerability of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution, 50 mg/mL (MR-301) in improving rate of recovery in patients with severe non-penetrating Traumatic Brain Injury (TBI)

PI: Katharine Colton, MD

Sub-I: Cherylee Chang, MD; Gabriel Torrealba-Acosta, MD

Study Coordinator: Amayrani Calvario Salgado

Sponsor: Shinkei Therapeutics

Status: Open

Accrual Goal: 4

CT.gov link to study: https://clinicaltrials.gov/study/NCT06253923?cond=NCT06253923&rank=1

CT.gov Identifier: NCT06253923

REMASTer

Protocol #: Pro00109334

Brief Summary: 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.

PI: Peter Fecci, MD, PhD

Lead Study Coordinator: Courtney Wimberly, MS

CRC Email: courtney.wimberly@duke.edu

Clinicaltrials.gov link: https://www.clinicaltrials.gov/study/NCT05124912

Clinicaltrials.gov Identifier: NCT05124912

Perioperative Evaluation of Cerebellar Tumors

Protocol #: Pro00105872

Brief Summary: Impact of Cerebellar Functional Topography on Cognition and Motor Ataxia.

PI: Allan Friedman, MD

Lead Study Coordinator: Brittney Nickerson, CRC, ROT

CRC Email: brittney.nickerson@duke.edu

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

Clinicaltrials.gov Identifier: NCT04463979

The NOTICE Study

Protocol #: Pro00103904

Brief Summary: Neurosurgery and OrThopedics Communication Evaluation Study Following Lumbar Fusions

PI: Oren Gottfried, MD

Lead Study Coordinator: Brittney Nickerson, CRC, ROT

CRC Email: brittney.nickerson@duke.edu

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/record/NCT04140344

Clinicaltrials.gov Identifier: NCT04140344

Assessment of Flow in Cerebrospinal Fluid Shunts with a Wireless Thermal Anisotropy Measurement Device, Phase B

Protocol #: Pro00110736

Brief Summary: Patients with an existing implanted ventriculoperitoneal (VP) shunt and who are experiencing shunt malfunction symptoms will be recruited by the clinical investigators at each investigational site in accordance with the inclusion and exclusion criteria. Assessment of shunt flow will be performed non-invasively with the study device; physician and clinical staff will be blinded to the device result. Standard-of-care assessment of shunt function will be performed and surgical intervention will occur based on the judgement of the treating neurosurgeon without the use of study device data. This trial will evaluate the ability of the study device to identify shunt malfunctions in need of surgical revision.

PI: Gerald Grant, MD

Lead Study Coordinator: Hazani Benitez-Rosas

CRC Email: hazani.benitez-rosas@duke.edu

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT05432986

Clinicaltrials.gov Identifier: NCT05432986

Assessment of CSF Shunt Flow With Thermal Measurements B (STEALTH)

Protocol #: Pro00110736

Brief Summary: Assessment of Flow in Cerebrospinal Fluid Shunts with a Wireless Thermal Anisotropy Measurement Device, Phase B

PI: Gerald Grant, MD

Lead Study Coordinator: Hazani Benitez-Rosas

CRC Email: hazani.benitez-rosas@duke.edu

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT05432986

Clinicaltrials.gov Identifier: NCT05432986

Temporal Patterns of Deep Brain Stimulation

Protocol #: Pro00074235

Brief Summary: 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.

PI: Warren Grill, PhD

Lead Study Coordinator: Jennifer Peters

CRC Email: jennifer.peters@duke.edu

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02553525

Clinicaltrials.gov Identifier: NCT02553525

Systematic Evaluation of VNS Parameters

Protocol #: Pro00103473

Brief Summary: This study measures the activation of the vagus nerve and the side effects of vagus nerve stimulation (VNS) (such as neck muscle contractions, changes in heart rate) across a range of stimulation parameters typically used in VNS therapy for epilepsy

PI: Warren Grill, PhD

Lead Study Coordinator: Jennifer Peters

CRC Email: jennifer.peters@duke.edu

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT#05395026

Clinicaltrials.gov Identifier: NCT05395026

Ferritin and Iron burden in SAH sIRB (UDISCO)

Protocol #: Pro00110138

Brief Summary: 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).

PI: David Hasan, MD, MSC

Lead Study Coordinator: Hazani Benitez-Rosas

CRC Email: hazani.benitez-rosas@duke.edu

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/record/NCT03754725

Clinicaltrials.gov Identifier: NCT03754725

MOBI-1

Protocol #: Pro00110744

Brief Summary: MOBI-1 is a multicenter clinical trial that will evaluate the use of the infrascanner for the monitoring of traumatic intracranial hematomas.

PI: Bradley Kolls, MD, PhD

Lead Study Coordinator: Tammy Hawley (Surgery-Emergency Medicine)

CRC Email: tammy.hawley@duke.eduu

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04893837

Clinicaltrials.gov Identifier: NCT04893837

SPR RESET Study

Protocol #: Pro00104955

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

PI: Nandan Lad, MD, PhD

Lead Study Coordinator: Brittney Nickerson, CRC, ROT

CRC Email: brittney.nickerson@duke.edu

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04246281

Clinicaltrials.gov Identifier: NCT04246281

SCS for SCI

Protocol #: Pro00106738

Brief Summary: Spinal Cord Stimulation for Spinal Cord Injury

PI: Nandan Lad, MD, PhD

Lead Study Coordinator: Allison Spell, CCRP

CRC Email: allison.spell@duke.edu

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04894734

Clinicaltrials.gov Identifier: NCT04894734

Cell Therapy for Epilepsy

Protocol #: Pro00108759

Brief Summary: This two-stage study is designed to evaluate the safety (Stage 1 and Stage 2) and efficacy (Stage 2) of inhibitory neuron transplantation in people with drug resistant mesial temporal lobe epilepsy (MTLE). In Stage 1, participants will receive transplants of NRTX-1001, an investigational cell product containing inhibitory neurons. In Stage 2, participants will be randomized to undergo either NRTX-1001 transplantation or a sham surgical procedure (which omits cell delivery). In both stages, participants will continue ongoing medical management of their epilepsy.

PI: Derek Southwell, MD, PhD

Lead Study Coordinator: Jodi Lennon, RN, BSN

Email: derek.southwell@duke.edu

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT05135091

Clinicaltrials.gov Identifier: NCT05135091

Tissue Explant Study

Protocol #: Pro00103019

Brief Summary: 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.

PI: Derek Southwell, MD, PhD

Lead Study Coordinator: Jodi Lennon, RN, BSN

CRC Email: jodi.lennon@duke.edu

HCRNq Core Data Project

Protocol #: Pro00112166

Brief Summary: The HCRN consists of multiple Clinical Centers and the Data Coordinating Center (DCC). The HCRN Core Data Project will obtain data about all neurosurgical hydrocephalus events from the network Clinical Centers, and create a database to be used by HCRN investigators. The ongoing maintenance of the Core Data Project serves two main purposes: 1) it will help investigators understand the variability, progression, and current treatment practices for hydrocephalus in children, with an ultimate goal of better guiding and assessing therapeutic intervention and providing recommendations on patient care and, 2) it will provide pilot and descriptive data necessary for hypothesis generation and study design (i.e. preliminary power analyses, recruitment projections) for studies under development by the HCRN. This multi-institutional database will be maintained throughout the lifetime of the HCRN, and may be useful for tracking trends in pediatric hydrocephalus over time.

PI: Matthew Vestal MD

Lead Study Coordinator: Hazani Benitez-Rosas

CRC Email: hazani.benitez-rosas@duke.edu

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00670735

Clinicaltrials.gov Identifier: NCT00670735

An International, Real-World, Observational Study of the Natural History of Subjects Diagnosed with Aromatic L-Amino Acid Decarboxylase Deficiency (AADC-d) (PTC_AADC_MA Observational Study

Protocol #: Pro00109412

Brief Summary: The purpose of this study is to describe the natural history of aromatic l-amino acid decarboxylase deficiency (AADC-d) in subjects on standard of care. Given the extreme rarity of AADC-d, there is limited information about the clinical presentation of this disease, prognostic factors, treatment patterns, and utilization of healthcare resources.

PI: Matthew Vestal, MD

Lead Study Coordinator: Hazani Benitez-Rosas

CRC Email: hazani.benitez-rosas@duke.edu