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 August 30, 2023

Protocol #: Pro00109334

Study Title: REMASTer

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://classic.clinicaltrials.gov/ct2/show/NCT05124912

Clinicaltrials.gov Identifier: NCT05124912

Protocol #: Pro00105872

Study Title: Perioperative Evaluation of Cerebellar Tumors

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

Protocol #: Pro00103904

Study Title: The NOTICE Study

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

Protocol #: Pro00110736

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

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

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

Protocol #: Pro00074235

Study Title: Temporal Patterns of Deep Brain Stimulation

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

Protocol #: Pro00103473

Study Title: Systematic Evaluation of VNS Parameters

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

Protocol #: Pro00110138

Study Title: Ferritin and Iron burden in SAH sIRB (UDISCO)

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

Protocol #: Pro00110744

Study Title: MOBI-1

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

Protocol #: Pro00104955

Study Title: SPR RESET Study

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

Protocol #: Pro00106738

Study Title: SCS for SCI

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

Protocol #: Pro00108759

Study Title: Cell therapy for epilepsy

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

Protocol #: Pro00103019

Study Title: Tissue Explant Study

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

Protocol #: Pro00112166

Study Title: HCRNq Core Data Project

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

Protocol #: Pro00109412

Study Title: 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

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