Neurosurgery Clinical Trials

BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia

Status: Recruiting
PI: Jaimie Henderson, MD
NCT00912041
Contact: Omar Rutledge, orutledge@stanford.edu

The purpose of the first phase of the pilot clinical study of the BrainGate2 Neural Interface System is 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. Another goal of the study is 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.

Individuals with limited or no ability to use both hands due to cervical spinal cord injury, brainstem stroke, muscular dystrophy, or amyotrophic lateral sclerosis (ALS) or other motor neuron diseases are being recruited into a clinical study at Massachusetts General Hospital (MGH) and Stanford University Medical Center. Clinical trial participants must live within a three-hour drive of Boston, MA or Palo Alto, CA. Clinical trial sites at other locations may be opened in the future. The study requires a commitment of 13 months.

Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE)

Status: Recruiting
PI: Casey Halpern, MD
Co-PI: Gerald Grant, MD, FACS
NCT02844465

The purpose of the study is to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for necrotization or coagulation of epileptogenic foci in patients with intractable mesial temporal lobe epilepsy.

The study will include approximately 120 adult patients with drug-resistant MTLE treated at selected epilepsy centers across the United States. After the Visualase procedure, patients will be followed for 12 months and evaluated for freedom from seizures, quality of life, adverse events, and neuropsychological outcomes.

The Role of the Striatum in Obsessive-Compulsive Disorder

PI: Casey Halpern, MD

Repetitive Transcranial Magnetic Stimulation to Improve Cognitive Function in TBI

Status: Recruiting
PI: Maheen Adamson, PhD
NCT02152540
Contact: Karen Cullen
karen.cullen@va.gov

The study will evaluate the safety, durability, and efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as a promising non- invasive therapeutic treatment for executive function (EF) deficits in Veterans with mild to moderate Traumatic Brain Injury (TBI).

Veterans, male and female, aged 20-65 with mild or moderate TBI, who are more than 2 months post-injury are being recruited. Patient evaluation, treatment with rTMS, and subsequent follow up will be conducted over a 7-9 month period.

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).

A Double-Blind, Controlled Phase 2 Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients with Chronic Motor Deficit from Traumatic Brain Injury (TBI)

Status: Closed to Enrollment, Active
PI: Gary K Steinberg, MD, PhD
NCT02416492
Contact: Kathy McDonald, kmcdonl@stanford.edu

The primary purpose of the clinical study is to evaluate the clinical efficacy of intracranial administration of SB623 cells on patients with chronic motor deficit from Traumatic Brain Injury. A secondary purpose of the study is 1) to evaluate the effect of intracranial administration of SB623 cells on disability parameters and 2) to evaluate the safety and tolerability of intracranial administration of SB623 cells. Patients with stable, chronic motor deficits secondary to focal traumatic brain injury must be between 12-60 months post TBI.

A Double-Blind, Controlled Phase 2B Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients with Chronic Motor Deficit from Ischemic Stroke

Status:Closed to Enrollment, Active
PI: Gary K Steinberg, MD, PhD
NCT02448641
Contact: Kathy McDonald, kmcdonl@stanford.edu

Controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from ischemic stroke. The ischemic stroke must be 6 month-60 month after injury.

The Neuroscience Brain Bank: Collection of Neurosurgical Tissue for Research (SQL 76892)

Status: Recruiting from clinics
PI: Gary K Steinberg, MD, PhD
Contact: Anthony Bet, abet0915@stanford.edu

Central Thalamic Deep Brain Stimulation for the Treatment of Traumatic Brain Injury

Status: Stanford is now accepting new patients for this trial.
PI: Jamie Henderson, MD
Contact: Omar Rutledge, orutledge@stanford.edu

Childhood Brain Tumor Tissue Consortium (CBTTC) Collection protocol

Status: Recruiting
PI: Gerald Grant, MD, FACS
Contact: Anthony Bet, abet0915@stanford.edu

Advancing Treatment for Pediatric Craniopharyngioma: Prospective Pilot Study Identifying Clinically Relevant Biological Targets for Medical Therapy

Status: Recruiting
PI: Gerald Grant, MD, FACS
Contact: Anthony Bet, abet0915@stanford.edu

The Park-Reeves Syringomyelia Research Consortium

Status: Ongoing, recruiting
PI: Gerald Grant, MD
Contact: Anthony Bet, abet0915@stanford.edu

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.
 

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

Status: Closed to Recruitment, Activities Continuing
PI: Laurence Katznelson, MD
NCT01794793
Contact: Anthony Bet, abet0915@stanford.edu

An Open-Label, Dose Finding, International Phase 2 Study with Once Monthly Subcutaneous Somavaratan in Adult Growth Hormone Deficiency (GHD) [Versartis International Trial in Adults with Long Acting Growth Hormone:The VITAL study]

Status: Closed to Recruitment, Activities Continuing
PI: Laurence Katznelson, MD
NCT02526420
Contact: Bharati Sanjanwala
bharatis@stanford.edu

Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in AGHD

Status: Recruiting
PI: Laurence Katznelson, MD
NCT02719990
Contact: Bharati Sanjanwala
bharatis@stanford.edu

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, MD
Status: Active, Recruiting
Contact:  Zoia Latev
lateva@stanford.edu

Prospective, Concurrently Controlled, Multi-center Study to Evaluate the Safety and Effectiveness of the Spinal Kinetics M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Symptomatic Cervical Radiculopathy

This is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy with or without cord compression. Some participating sites will enroll just M6-C patients, while others will enroll just ACDF patients.

Patients eligible for study enrollment will present with degenerative cervical radiculopathy requiring surgical intervention, confirmed clinically and radiographically, at one vertebral level from C3 to C7.

Status: Closed to Enrollment, Activities Continuing
PI: Lawrence Shuer, MD
NCT01609374

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