Palmer Lab

Neurosurgery Clinical Trials

A I/IIA Study of the Safety and Efficacy of Modified Stromal Cells (SB623) in Patients with Stable Ischemic Stroke
The primary purpose of the clinical study is to determine the safety of a modified stem cell SB623 when administered to chronic, stable ischemic stroke patients. A second purpose is to determine whether SB623 might improve stroke symptoms. Chronic, stable ischemic stroke patients must be between 6 and 60 months after their stroke, and with only this one prior stroke, and with no further improvement from physical therapy.
PI: Gary K. Steinberg, MD, PhD (NCT01287936)

Familial Intracranial Aneurysm (FIA) Study
To explore genetic and environmental factors associated with the incidence of familial intracranial aneurysms.  The study continues to enroll non-familial affected patients. 
PI: Gary K. Steinberg, MD, PhD (NCT00071565)

North American Clinical Trials Network (NACTN) The Department of Neurosurgery is a member of the North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury, whose mission is to bring promising therapies out of the laboratory and into clinical trials.  A recent Phase I trial showed that the oral medication Riluzole may have some efficacy in reducing impairment if given during the first two weeks after spinal cord injury. A Phase II trial is now being planned to examine the safety and efficacy of Riluzole in more detail.
PI: Graham Creasey

The Canadian Multicentre CSF Monitoring and Biomarker Study (CAMPER)
The Department of Neurosurgery will this year become the first US site in this multi-center study supported by the Rick Hansen Institute of Canada to monitor pressure around the spinal cord during the first week after spinal cord injury and to sample cerebrospinal fluid for biomarkers of injury.
PI: Graham Creasey

Evaluation of Pudendal Nerve Block and Stimulation for Voiding and Continence
This Phase I four-year clinical trial supported by the Department of Defense will evaluate a second generation neural prosthesis for restoring bladder emptying and continence using electrical stimulation without posterior rhizotomy.
PI: Graham Creasey

M6®-C Artificial Cervical Disc IDE Pivotal StudyThis two year, multi-center clinical trial is looking at the safety and effectiveness of the Spinal Kinetics M6-C artificial cervical disc in patients with symptomatic cervical radiculopathy, requiring surgical intervention at one vertebral level from C3 to C7. The M6-C artificial cervical disc is an advanced generation artificial disc designed to replicate the anatomic, physiologic and biomechanical characteristics of the native disc.
PI: Lawrence Shuer

A Study of Patient Reported Outcomes after Stereotactic Radiosurgery for Trigeminal Neuralgia
PI: Scott G. Soltys, MD (NCT01364285)

Radiosurgical Neuromodulation for Refractory Depression
Co-PIs: Hugh Brent Solvason, MD, PhD and John Adler, MD (NCT01403441)

A Phase I Trial of Vorinostat Concurrent with Stereotactic Radiotherapy in Treatment of Brain Metastases from Non-Small Cell Lung Cancer 
PI: Griff Harsh, MD (NCT00946673)

Comparison of Overall Survival Post-CyberKnife Radiosurgery Treatment of Patients with 1–3 versus 4 or more Brain Metastases 
PI:  Steven D. Chang, MD; Co-Investigators: Judith A Murovic, MD, Griffith Harsh, MD, Gordon Li, MD, Iris C. Gibbs, MD, Scott Soltys, MD, Steve Hancock, MD (NCT01778764)

A Study of Amifostine for Prevention of Facial Numbness in Patients Receiving Stereotactic Radiosurgery for Trigeminal Neuralgia 
PI: Scott Soltys, MD (NCT01364259)

A Phase I/II Trial of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases
To determine the optimal radiation dose for large brain metastases.
PI: Scott Soltys, MD (NCT00928226)

Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults
To elucidate the effects of growth hormone replacement in patients with growth hormone deficiency on cognitive function using structural and functional neuroimaging and cognitive testing. 
PI: Laurence Katznelson, MD (NCT01007071)

An Open Label, Multi-Center Pasireotide Roll-Over Protocol for Patients who have Completed a Previous Novartis-sponsored Pasireotide Study and are Judged by the Investigator to Benefit from Continued Pasireotide Treatment
PI: Laurence Katznelson, MD (NCT01794793)

An Acromegaly, Open-label, Multi-center, Safety Monitoring Program for Treating Patients with SOM230 (Pasireotide) LAR who have Need to Receive Medical Therapy (ACCESS)
PI: Laurence Katznelson, MD (NCT01995734)

A Randomized, Double-Blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients with Cushing's Disease
PI: Laurence Katznelson, MD (NCT01374906)

A Phase II Study of Rindopepimut/GM-CSF in Patients with Relapsed EGFRvIII-Positive Glioblastoma (ReACT)
To study if adding the experimental vaccine rindopepimut (also known as CDX-110) to bevacizumab can improve progression free survival (slow the growth of tumors) in patients with relapsed EGFRvIII positive glioblastoma.
PI: Gordon Li, MD (NCT01498328)

Progesterone for the Treatment of Traumatic Brain Injury (ProTECT III)
The ProTECT study will determine if intravenous (IV) progesterone, started within 4 hours of injury and given for a total of 96 hours, is more effective than placebo for treating victims of moderate to severe acute traumatic brain injury.
Stanford PI: Jim Quinn, MD
Sub-PI: Marco Lee, MD (NCT00822900)

An International, Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma (ACT IV)
PIs: Lawrence Recht, MD and Seema Nagpal, MD (NCT01480479)

A Phase I/ll Trial of Temozolomide and Hypofractionated Radiotherapy in the Treatment of Supratentorial Glioblastoma Multiforme
To determine the safety and effectiveness of 1 week versus 6 weeks of hypofractionated radiotherapy in combination with temozolomide 
PI: Scott G. Soltys, MD (NCT01120639)

The Park-Reeves Syringomyelia Research Consortium
A multi-center research effort to create a disease registry of syringomyelia and chiari I malformation to study these disorders, their natural history and clinical course.
PI: Gerald Grant, MD

Bone Flap Resorption after Cranioplasty in Children: A Multicenter Retrospective Study
A multi-center, retrospective review of pediatric cranioplasty patients to determine what risk factors play a role in infection and bone flap resorption.
PI: Gerald Grant, MD

Investigation of DTI MRI as a Correlate to Pain Relief and Facial Numbness in Patients Following Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia
PI: Scott Soltys, MD (NCT01364272)

BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons with Tetraplegia
To obtain preliminary device safety information and to demonstrate the feasibility of people with tetraplegia using the System to control a computer cursor and other assistive devices with their thoughts. Additionally to determine the participants’ ability to operate communication software, such as e-mail, simply by imagining the movement of their own hand. The study is invasive and requires surgery.
PI: Jaimie Henderson, MD (NCT00912041)

DuraSeal TM Exact Spine Sealant System Post-Approval Study
The purpose of this clinical trial is to compare DuraSeal Exact Spine Sealant with other fibrin sealants in preventing cerebrospinal fluid (CSF) leak after primary repair of Dura.  Duraseal Spine Sealant is indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure.
PI: Harminder Singh, MD; Co-PIs: Marco Lee, MD, PhD; Jason Lifshutz, MD

For questions about these clinical trials please contact our clinical trials research coordinator Maria Coburn at 650-736-9551 or


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