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
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
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
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
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
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
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
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
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
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
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
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