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 March 9, 2023

Protocol # Pro00112166

Study Name: HCRNq Core Data Project

Brief Summary: The Hydrocephalus Clinical Research Network (HCRN) has been established by philanthropic funding to conduct multi-institutional research (clinical trials and observational studies) on pediatric hydrocephalus. In addition to philanthropic funding, the HCRN has also received an NIH NINDS Challenge Grant to support the network infrastructure which allows for the conduct of this and other network studies. 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. The Core Data Project will be an invaluable resource to the HCRN and will help stimulate new research protocols, identify potential need for future expansion of the network to incorporate additional patient populations, and provide a descriptive understanding of children with hydrocephalus cared for within the network.

PI: Dr. Matthew Vestal

Sub-I: Drs. Herbert Fuchs and Gerald Grant

Study Coordinator: Hazani Benitez-Rosas

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

Sponsor: Duke University

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

Clinicaltrials.gov Identifier: NCT00670735

Protocol #: Pro00108630

Study Name: 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

CRC Email: Allison.spell@duke.edu

Protocol #: Pro00109334

Study Name: 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

PI Name: Dr. Peter Fecci, MD, PhD

Lead CRC Name: Anna Thirakul, CCRP

CRC Email: anna.thirakul@duke.edu

Protocol #: Pro00110138

Study Name: 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

PI: Dr. David Hasan

Lead CRC: Anna Thirakul

CRC Email: anna.thirakul@duke.edu

Protocol #: Pro00108759

Study Name: 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

PI Name: Derek Southwell, MD, PhD

Lead CRC Name: Jodi Lennon

CRC Email: Jodi.lennon@duke.edu

Protocol #: Pro00071347

Study Name: 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

PI: Peter Fecci, MD, PhD

Lead CRC: Courtney E. Wimberly, MS

CRC Email: Courtney.wimberley@duke.edu

Protocol #: Pro00104955

Study Name: SPR RESET Study

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

PI Name: Thomas Hopkins, MD, MBA

Lead CRC Name: Brittney Nickerson, CRC, ROT

CRC Email: Brittney.nickerson@duke.edu

Protocol #: Pro00106738

Study Name: SCS for SCI

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

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

Clinicaltrials.gov link

PI Name: Nandan Lad, MD, PhD

Lead CRC Name: Allison Spell, CCRP

CRC Email: Allison.spell@duke.edu

Protocol #: Pro00105872

Study Name: 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

PI: Allan Friedman, MD

Lead CRC Name: Brittney Nickerson, CRC, ROT

Protocol# 00103904

Study Name: The NOTICE Study

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

ClinicalTrials.gov Identifier: NCT04140344

PI: Oren Gottfried, MD

Lead CRC Name: Brittney Nickerson, CRC, ROT

CRC Email: Brittney.nickerson@duke.edu

Protocol #: Pro00101198

Study Name: 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

PI Name: C. Rory Goodwin, MD, PhD

Lead CRC Name: Courtney E. Wimberley, MS

CRC Email: Courtney.wimberley@duke.edu

Protocol #: Pro00102543

Study Name: MTRON

Brief Description of Study: Metastatic Tumor Research and Outcomes Network

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

Clinicaltrials.gov link

PI Name: C. Rory Goodwin, MD, PhD

Lead CRC Name: Courtney E. Wimberley, MS

CRC Email: Courtney.wimberley@duke.edu

Protocol #: Pro00074235

Study Name: 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

PI Name: Warren Grill, PhD

Lead CRC Name: Jennifer Peters

CRC Email: Jennifer.peters@duke.edu

Protocol #: Pro00103019

Study Name: 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

CRC Email: Jodi.lennon@duke.edu

Study title: NON-INVASIVE MONITORING OF TRAUMATIC BRAIN INJURY PROGRESSION USING THE INFRASCANNER 1 (MOBI-1)

IRB Number: Pro00110744

Short title: MOBI-1

PI: Dr. Anthony Fuller

Sub-I: Drs. Bradley Kolls and Alexander Limkakeng

Study Coordinator: Tammy Hawley (Surgery – Emergency Medicine)

Sponsor: US Department of Defense (DOD)

Status: Open

Accrual goal: 44

CT.gov link to study: https://clinicaltrials.gov/ct2/show/NCT04893837

CT.gov Identifier: NCT04893837

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

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

IRB Number: Pro00109412

Short title: PTC-AADC-MA Observational Study

PI: Dr. Matthew Vestal

Sub-I: Dr Muhammad Zafar

Study Coordinator: Hazani Benitez-Rosas

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

Sponsor: PTC Therapeutics, Inc.

Status: Open

Accrual goal: 3

CT.gov link to study:

CT.gov Identifier:

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.

Study title: Identifying mTOR Dependent Periods During Brain Development

IRB Number: Pro00108389

Short title: mTOR Dependence - Human Tissue Study

PI: Dr. Matthew Vestal

Sub-I: Drs. Derek Southwell

Study Coordinator: Hazani Benitez-Rosas

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

Sponsor: Duke University

Status: Open

Accrual goal: 20

CT.gov link to study: N/A

CT.gov Identifier: N/A

Brief Summary: The purpose of this study is to use any extra tissue samples obtained during brain surgery that may otherwise be discarded. These will mainly be limited to patients with epilepsy and receiving epilepsy surgery but can also extend to brain tumors and other neurological disorders requiring neurosurgical intervention. We will look at the cells with a microscope and also look for any changes in proteins and genes in this tissue.

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

IRB Number: Pro00110736

Short title: FlowSense Assessment Study

PI: Dr. Gerald Grant

Sub-I: Drs. Carter Lacey, Herbert Fuchs, Alexander Suarez, and Matthew Vestal.

Study Coordinator: Beth Perry

CRC Email: beth.perry@duke.edu

Sponsor: Rhaeos, Inc.

Status: Open

Accrual goal: 14

CT.gov link to study: https://clinicaltrials.gov/ct2/show/NCT05432986

CT.gov Identifier: NCT05432986

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.

Protocol #: Pro00103473

Study Short Title: Systematic Evaluation of VNS Parameters

Brief Description: 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.

NCT #: NCT05395026

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT05395026

PI: Warren Grill, PhD

Lead CRC: Jennifer Peters

CRC Email: Jennifer.peters@duke.edu