Neurosurgery Clinical Trials
The Stanford Department of Neurosurgery is at the forefront of clinical trials, offering potential therapies not offered anywhere else in the world. Our studies examine therapies for everything from brain trauma and spinal cord injury to pediatric brain tumors and stroke. The results of these studies and the discoveries in our labs translate into new, innovative, and minimally-invasive therapies for patients.
Brain Tumor
Newly Diagnosed Glioma
A Phase I Study of Tumor Treating Fields with 5-Day Hypofractionated Stereotactic Radiosurgery and Concurrent and Maintenance Temozolomide in Newly Diagnosed Glioblastoma
PI: Scott Soltys, MD
NCT04474353
Contact:
Eleanor Brown eleanor9@stanford.edu 650-724-4606
Katy Barnick kbarnick@stanford.edu 650-497-8966
Follow-Up Study to Add Whole Brain Radiotherapy (WBRT) to Standard Temozolomide Chemo-Radiotherapy in Newly Diagnosed Glioblastoma (GBM) Treated with 4 Weeks of Continuous Infusion Plerixafor
PI: Lawrence Recht, MD
ClinicalTrials.gov#: NCT03746080
Contact: Neuro Onc CRCs
A Phase II Study of BPM31510 with Vitamin K1 in Subjects with Newly Diagnosed Glioblastoma (GB)
PI: Seema Nagpal, MD
NCT04752813
Contact: Neuro Onc CRCs
Pivotal, Randomized, Open-label Study of Optune (Tumor Treating Fields) Concomitant with RT & TMZ for the Treatment of Newly Diagnosed GBM (EF-32)
PI: Seema Nagpal, MD
NCT04471844
Contact: Neuro Onc CRCs
Recurrent High Grade Glioma
Phase I Clinical Trial of Locoregionally (LR) Delivered Autologous B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Adults with Recurrent Glioblastoma Multiforme (GBM)
PI: Reena Thomas, MD PhD
ClinicalTrials.gov#: NCT05474378
Contact: Neuro Onc CRCs
Brain Metastases
Study Assessing QBS72S For Treating Brain Metastases of Triple Negative Breast Cancer
PI: Melanie Hayden Gephart, MD
ClinicalTrials.gov#: NCT05305365
Contact: Neuro Onc CRCs
BRAF V600 Mutations
A Phase I, First-In-Human, Multicenter, Open-Label Study of ABM-1310, Administered Orally in Adult Patients with Advanced Solid Tumors
PI: Seema Nagpal, MD
NCT04190628
Contact: Neuro Onc CRCs
NTRK-Fusion Positive
A Phase I/II Study of PBI-200 in Subjects with NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors
PI: Seema Nagpal, MD
NCT04901806
Contact: Neuro Onc CRCs
Primary CNS Lymphoma
An Open-Label Phase II Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Tirabrutinib in Patients with Primary Central Nervous System Lymphoma (PCNSL)
PI: Neel Gupta, MD
ClinicalTrials.gov#: NCT04947319
Contact: Neuro Onc CRCs
CNS Diagnostic Imaging
A Phase I Study of [18F]DASA-23 as a PET Tracer for Evaluating Pyruvate Kinase M2 (PKM2) Expression in Healthy Volunteers and in Patients with Intracranial Tumors
PI: Guido Davidzon, MD SM
NCT03539731
Cerebrovascular Surgery
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of REC-994 in the Treatment of Symptomatic Cerebral Cavernous Malformation - REC-994-201
PI: Gary Steinberg, MD, PhD
Study Status: Not yet recruiting
Contact: Anthony Bet or Guiping Qin
Study of PHIL® (Precipitating Hydrophobic Injectable Liquid) Embolic System in the Treatment of Intracranial Dural Arteriovenous Fistulas
PI: Huy Do, MD
NCT03467542
Study Status: Enrolling
Research Coordinator: Hong Ye and Anthony Bet
Contact: hye2@stanford.edu or abet0915@stanford.edu
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) Protocol
PI: Gary Steinberg, MD
NCT02089217
Study Status: Enrolling
Research Coordinator: Guiping Qin
Contact: gqin68@stanford.edu
The Neuroscience Brain Bank: Collection of Neurosurgical Tissue for Research
PI: Gary Steinberg, MD
Study Status: Enrolling
Research Coordinator: Hong Ye
Contact: hye2@stanford.edu
A prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the efficacy and safety of clazosentan in preventing clinical deterioration due to delayed cerebral ischemia (DCI), in adult subjects with aneurysmal subarachnoid hemorrhage (aSAH)
PI: Gary Steinberg, MD
NCT03585270
Study Status: Enrollment open soon
Research Coordinator: Hong Ye
Contact: hye2@stanford.edu
A prospective, Multicenter study to Evaluate the Performance and Safety of the CerebroFlo EVD Catheter: C-CERFLO-001
PI: Lawrence Shuer, MD
NCT05113381
Contact: Anthony Bet or Guiping Qin
Functional Neurosurgery
A Continued Access Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
PI: Pejman Ghanouni, MD, PhD
NCT02289560
Study Status: Closed to Enrollment
A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
PI: Pejman Ghanouni, MD, PhD
NCT01827904
Study Status: Closed to Enrollment
Global Registry: ExAblate 4000 transcranial MR guided focused ultrasound (TcMRgFUS) of Neurological Disorders
PI: Pejman Ghanouni, MD, PhD
Study Status: Closed to Enrollment
Stereotactic Laser Ablation for Temporal Lobe Epilepsy
PI: Casey Halpern
NCT02844465
Study Status: Enrolling
Research Coordinator: Bharati Sanjanwala
Contact: bharatis@stanford.edu
Responsive neurostimulation for loss of control eating
PI: Casey Halpern, MD
NCT03868670
Study Status: Enrolling
Research Coordinator: Tricia Cunningham
Contact: tcunningham@stanford.edu
A 12-Month Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Deep Brain Stimulation of the Fornix (DBS-f) in Patients With Mild Probable Alzheimer’s Disease (ADvance II)
PI: Casey Halpern, MD
NCT03622905
Study Status: Enrolling
A Pivotal Clinical Trial of the Management of the Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Idiopathic Parkinson’s Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Neuro System
PI: Casey Halpern, MD
NCT03319485
Study Status: Closed to Enrollment
Giving Voice to Neuroethics
PI: Jaimie Henderson, MD
Study Status: Enrolling
Research Coordinator: Hong Ye
Contact: hye2@stanford.edu
Central Thalamic Deep Brain Stimulation for the Treatment of Traumatic Brain Injury
PI: Jaimie Henderson, MD
NCT02881151
Study Status: Enrolling
Research Coordinator: Hong Ye
Contact: hye2@stanford.edu
BrainGate2: Feasibility Study of an Intracortical Neural System for Persons with Tetraplegia
PI: Jaimie Henderson, MD
NCT00912041
Study Status: Enrolling
Research Coordinator: Hong Ye, Anthony Bet
Contact: hye2@stanford.edu or abet0915@stanford.edu
BrainGate3: Feasibility Study of a Fully-Implantable, Wireless Intracortical Neural Interface System for Persons with Tetraplegia
PI: Jaimie Henderson, MD
Study Status: Not yet enrolling
Contact:
BHV3000-202: Phase 2: A Double-Blind, Placebo Controlled, Crossover Trial of BHV-3000 (Rimegepant) for Treatment Refractory Trigeminal Neuralgia
PI: Michael Lim, MD
NCT03941834
Study Status: Enrolling
Contact: Anthony Bet
ENCASE II Randomized, two-arm, multicenter study to Evaluate the safety and efficacy of Dura Sealant Patch in reducing CSF leakage following elective cranial surgery
PI: Jaimie Henderson, MD
Study Status: Not yet enrolling
Banu Priya Rathinam Radha Rajasekaran
Head and Spine Trauma
Efficacy of Repetitive Transcranial Magnetic Stimulation for Improvement of Memory in Older Adults with TBI
Status: Recruiting
PI: Maheen Adamson, PhD
NCT03727737
Contact: Harlene Grewal Harlene.Grewal@va.gov
A Phase 1/2 Dose Escalation Study of AST-OPC1 in Subjects with Subacute Cervical Spinal Cord Injury
Status: Closed to Enrollment, Active
PI: Gary K Steinberg, MD, PhD
NCT02302157
Contact: neuroscienceclinicaltrial@stanford.edu
Pediatric Neurosurgery
Childhood Brain Tumor Tissue Consortium (CBTTC) Collection protocol
PI: Gerald Grant, MD, FACS
Study Status: Enrolling
Research Coordinator: Anthony Bet
Contact: abet0915@stanford.edu
Advancing Treatment for Pediatric Craniopharyngioma: Prospective Pilot Study Identifying Clinically Relevant Biological Targets for Medical Therapy
PI: Gerald Grant, MD, FACS
Study Status: Enrolling
Research Coordinator: Anthony Bet
Contact: abet0915@stanford.edu
Posterior Fossa Decompression with or without Duraplasty for Chiari type I Malformation with Syringomyelia
PI: Gerald Grant, MD, FACS
Study Status: Closed to Enrollment
Research Coordinator: Anthony Bet
Contact: abet0915@stanford.edu
The Park-Reeves Syringomyelia Research Consortium
PI: Gerald Grant, MD, FACS
Study Status: Enrolling
Research Coordinator: Anthony Bet
Contact: abet0915@stanford.edu
A Prospective Validation Evaluation of a Novel Non-Invasive Sensor Device for Safe and Simplified Intracranial Pressure (ICP) Monitoring
PI: Gerald Grant, MD, FACS
Study Status: Closed to Enrollment
Research Coordinator: Guiping Qin
Contact: gqin68@stanford.edu
HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)
PI: Kelly Mahaney, MD
Study Status: Enrolling
Research Coordinator: Hong Ye
Contact: hye2@stanford.edu
The Chiari Surgical Success Scale (CSSS) Observational Study
PI: Gerald Grant, MD, FACS
Contact: Anthony Bet or Guiping Qin
An Open-Label Trial to Address the Safety of the SmartFlow® Compatible Ventricular Cannula for Administering Eladocagene Exuparvovec to Pediatric Subjects: PTC-AADC-GT-002 (GENE TRANSFER)
PI: Gerald Grant, MD, FACS
Contact: Anthony Bet or Guiping Qin
An international, real-world, observational study of the natural history of subjects diagnosed with Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency: PTC- AADC- MA-406 AADC Observational Study
PI: Gerald Grant, MD, FACS
Contact: Anthony Bet or Guiping Qin
Peripheral Nerve Surgery
Nerve Transfers to Improve Upper Extremity Function and Quality of Life in Tetraplegic Patients
PI: Thomas Wilson, MD
Study Status: Enrolling
Research Coordinator: Hong Ye/ Anthony Bet
Contact: hye2@stanford.edu or abet0915@stanford.edu
Pituitary
A Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to assess efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly
Status: Recruiting
PI: Laurence Katznelson, MD
NCT04076462
Research Coordinator: Bharati Sanjanwala
Contact: bharatis@stanford.edu
A Phase 3, open-label, single-arm, multi-center trial to assess the long-term safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly
Status: Recruiting
PI: Laurence Katznelson, MD
NCT04125836
Research Coordinator: Bharati Sanjanwala
Contact: bharatis@stanford.edu
Spine
Improving Spine Care with Real-Time Objective Patient Tracking with Apple Watch
PI: Corinna Clio Zygourakis
NCT04379921
Contact: Parastou Fatemi
M6-C Artificial Cervical Disc IDE Post-Approval Study
PI: Lawrence Shuer, MD
NCT04122248
Contact: Anthony Bet or Guiping Qin
Stroke
A Phase 1/Phase 2 Safety, Tolerability and Efficacy Study of Intracerebral Transplantation of Neural Stem Cells (NR1) in Subjects with Chronic Ischemic Subcortical Stroke (ISS) and Early Evaluation of Potentially Useful Efficacy Parameters
NCT04631406
PI: Gary Steinberg, MD, PhD
Study Status: Enrolling
Research Coordinator: Guiping Qin gqin68@stanford.edu
Recruitment & screening Contact: Kathy McDonald kmcdonal@stanford.edu
A Randomized, Placebo-Controlled Study of the Efficacy and Safety of Intracerebral Stem Cells (CTX0E03) in Subjects with Disability Following an Ischemic Stroke (PISCES III)
PI: Gary Steinberg, MD
NCT03629275
Study Status: Enrolling
Research Coordinator: Anthony Bet, Guiping Qin
Contact: abet0915@stanford.edu or gqin68@stanford.edu
A Double-Blinded, Controlled Phase 2B Study for the Safety and Efficacy of Modified Stem Cells (SB623) in Patients with Chronic Motor Deficit from Ischemic Stroke
PI: Gary Steinberg, MD
Study Status: Closed to Enrollment
Research Coordinator: Guiping Qin
Contact: gqin68@stanford.edu
A Double-Blinded, Controlled Phase 2 Study for the Safety and Efficacy of Modified Stem Cells (SB623) in Patients with Chronic Motor Deficit from Traumatic Brain Injury
PI: Gary Steinberg, MD
Study Status: Closed to Enrollment
Research Coordinator: Guiping Qin
Contact: gqin68@stanford.edu
iCAS - Imaging Collaterals in Acute Stroke
The overall goal of the imaging the Collaterals in Acute Stroke (iCAS) study is to identify and quantify cerebral blood flow (CBF) delivered via collateral routes using arterial spin labeling (ASL), a non-contrast MRI technique, and to determine its impact on ischemic lesion growth and patient outcome. NCT02225730
PI: Gregory Zaharchuk, MD
Status: Completed
SHINE - Stroke Hyperglycemia Insulin Network Effort Trial
This is a Phase III multicenter, randomized and controlled clinical trial of 1400 patients within 12 hours of stroke symptom onset, with diabetes and glucose concentrations of over 110 mg/dL on initial evaluation to determine if treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in improved 3 month outcome after stroke. Protocol ID: 23077, NCT01369069
PI: James Quinn, MD
Status: Completed
Blood Transcriptome of Transient Ischemic Attack
This study will examine gene expression in the blood of patients with Transient Ischemic Attach (TIA) / minor strokes compared to various types of control subjects. The purpose of this study is to learn whether there are changes in molecules in blood called RNA change after TIA / minor stroke.
Protocol ID: 37711
PI: Paul George, MD, PhD
Status: Completed
SALVO - Statins Augment Small Vessel Function and Improve Outcomes in Acute Ischemic Stroke
The purpose of this research study is to learn whether people who are taking a type of drug, called statins have different outcomes after they have a stroke than people who do not take statins. Statins are a type of medicine used to lower cholesterol and prevent heart disease or stroke.
Protocol ID: 39700
PI: Christina Mijalski-Cells, MD
Status: Completed