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.
Cerebrovascular Surgery
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
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
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
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
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
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
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
Research Coordinator: Vyvian Ngo
Contact: vyviann@stanford.edu
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
Research Coordinator: Vyvian Ngo
Contact: vyviann@stanford.edu
Global Registry: ExAblate 4000 transcranial MR guided focused ultrasound (TcMRgFUS) of Neurological Disorders
PI: Pejman Ghanouni, MD, PhD
Study Status: Closed to Enrollment
Research Coordinator: Vyvian Ngo
Contact: vyviann@stanford.edu
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
Research Coordinator: Vyvian Ngo
Contact: vyviann@stanford.edu
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
Research Coordinator: Vyvian Ngo
Contact: vyviann@stanford.edu
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
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 GrewalHarlene.Grewal@va.gov
Many older adults with Traumatic Brain Injury (TBI) report cognitive problems that last for months or years. The most common cognitive deficits occur in the areas of verbal fluency, attention, working memory, planning, and mental flexibility. This study will evaluate the safety, durability and efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as a promising non-invasive therapeutic treatment for improving memory in older adults with mild or moderate Traumatic Brain Injury (TBI) who have been experiencing residual memory or cognitive problems. Patients aged 50-75 years with mild or moderate TBI, who are more than 6 months post-injury and currently experiencing memory or cognitive problems, are being recruited. Evaluation, treatment with rTMS, and subsequent follow up will be conducted over a 6-8 month period. In addition, advanced neuroimaging (PET MRI) will be conducted.
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
The purpose of this study is to evaluate the safety of 3 sequential escalating doses of AST-OPC1 administered at a single time-point between 14 and 30 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).
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
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
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
Stroke
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: RECRUITING
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: RECRUITING
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: RECRUITING
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: RECRUITING