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Clinical Trials

A clinical trial is a biomedical research study involving human subjects that is designed to answer specific questions about the safety and efficacy of surgical treatments, drugs, supplements, vaccines, devices, new uses for older therapies, or other investigations. Clinical trials present a unique opportunity for physicians and patients to work together to improve individual and collective health care. Volunteers with a particular disease or condition are empowered to take an active role in their care, presented access to new options and treatment courses before they are widely available, and are able to influence the future of patient care.

For more information on clinical trials, visit the links below courtesy of clinicaltrials.gov:
Understanding clinical trials   
New clinical studies worldwide.     

CURRENT CLINICAL TRIALS

Seizure Prophylaxis in Aneurysm Repair (SPAR) Study
Principal Investigator: Aaron Cohen-Gadol, MD
Purpose: The goal is to examine the effectiveness of levetiracetam (Keppra) for seizure prevention in patients undergoing surgical repair of their unruptured brain aneurysms.

Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
Principal Investigator: Aaron Cohen-Gadol, MD
Purpose: The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and the Yellow 560 Microscope to help in the treatment of brain tumors and vascular lesions. The objectives aim to investigate the use of Fluorescein in assisting with evaluating complete tumor removal and thorough treatment for vascular lesions.

Aneurysm Wall Histology and Correlation with Cerebrospinal Fluid and Blood Plasma-Registry
Principal Investigator: Aaron Cohen-Gadol, MD
Purpose: This is a prospective registry to determine if subjects harboring brain aneurysms have any predictive markers between aneurysm wall tissue, cerebrospinal fluid, and blood plasma.

An Assessment of P-15 Bone Putty in Anterior Cervical Fusion with Instrumentation
Principal Investigator: Eric Potts, MD
Purpose: The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not inferior in effectiveness and safety to local autologous bone (control device) when applied in instrumented anterior cervical discectomy and fusion (ACDF) with use of a structural allograft ring in patients with degenerative cervical disc disease.

Success Using Neuromodulation with BURST (SunBurst) Study
Principal Investigator: Derron Wilson, MD
Purpose: The purpose of the study is to demonstrate the safety and efficacy of the Prodigy system for the treatment of chronic intractable pain of the trunk and/or limbs.

Incidence of Venous Thromboembolism in Children undergoing Elective Neurosurgical Procedures
Principal Investigator: Daniel Fulkerson, MD
Purpose: The purpose of this study is to determine how frequently children undergoing elective neurosurgical procedures develop blood clots in the deep veins of the legs while hospitalized.

The Park-Reeves Syringomyelia Consortium
Principal Investigator: Jodi Smith, MD
Purpose: The purpose of this multi-center registry is to learn about the major causes, natural history, and best treatments for syringomyelia and Chiari malformations.

IMRIS Multi-Center iMRI Neurosurgery Database (I-MiND)
Principal Investigator: Mitesh Shah, MD
Purpose: The purpose of this registry is to collect information regarding long-term outcomes of procedures utilizing intra-operative MRI, to improve current procedures and develop future uses for the IMRIS intra-operative MRI technology.

Spineology LIFT (Lumbar Interbody Fusion Trial)
Principal Investigator: Richard B. Rodgers, MD
Purpose: The purpose of this study is to evaluate the safety and effectiveness of SpineologyOptimesh 1500E deployable mesh filled with “AFT” allograft (investigational device) and stabilized with supplemental posterior pedicle screw fixation for treatment of degenerative disc disease.

Clinical Investigation into Novel Therapeutic Target in Traumatic Brain Injury and Spinal Cord Injury
Principal Investigator: Richard B. Rodgers, MD
Purpose: The purpose of this study is to determine if levels of acrolein, a neurotoxin, are elevated immediately following traumatic brain and spinal cord injuries.

RELIEF: A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
Principal Investigator: Steven James, MD
Purpose: The purpose of this study is to compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice.