Neurosurgery

Current Clinical Trials

If you are already enrolled in a neurosurgery trial and have specific questions related to your study, please call any of the doctors or nurses listed on the front page of your consent form.

If you have general questions related to neurosurgery clinical trials you may call Eileen Maloney-Wilensky, neurosurgery clinical research division director, at 215-662-6462.

Dystonia

Humanitarian Device Exemption (HDE#H0200007) of a Humanitarian Use Device for Medtronic Activa Therapy, allowing unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Dystonia.

Brain Tumors

ACT IV

An international, randomized, double-blind, controlled study of rindopepimut/GM-CSF with adjuvant temozolomide in patients with newly diagnosed, surgically resected, EGFRvIII-positive glioblastoma.

DCVax-L

A Phase III clinical trial evaluating DCVax-L, autologous dendritic cells pulsed with tumor lysate antigen for the treatment of glioblastoma multiform.

ReACT

A phase II study of rindopepimut/GM-CSF in patients with relapsed, EGFRvIII-positive glioblastoma.

NovoTTF-100A

A prospective, multi-center trial of NovoTTF-100A together with temozolomide compared to temozolomide alone in patients with newly diagnosed GBM.

Language Recovery

A total of 20 patients with newly diagnosed dominant-hemisphere brain tumors in regions that are classically associated with language function will be enrolled in this single-site pilot study at the University of Pennsylvania. The overall objective is to improve the accuracy of language mapping in brain tumor patients in order to maximize the amount of tumor resected while minimizing new post-operative language deficits. Enrolled patients undergo a comprehensive set of pre-operative tests, including standard-of-care structural and function MRI (fMRI) as well as neuropsychological language assessment, magnetoencephalography (MEG)-based language mapping, and cerebral perfusion measurements. After surgery with intra-operative language mapping, patients undergo post-operative structural MRI and repeat language evaluation.

ACRIN 6684

A multicenter phase II assessment of tumor hypoxia in glioblastoma using F-Fluoromisonidazole (FMISO) with PET and MRiI Indication: Newly diagnosed GBM.

Diamox

Pilot study using IV acetazolamide (Diamox) in MRI to induce changes in CBF and CBV in patients with non-enhancing grade II or III astrocytomas or oligodendroglioma.

Proton Radiation for Low Grade Gliomas

Objective: To evaluate the feasibility of proton beam radiation therapy in patients with low grade gliomas.

Proton/Photon Radiotherapy

Detection of vascular and neuronal changes following proton and/or photon radiotherapy in patients receiving skull base and/or brain radiation.

Proton Radiation

Phase II study using proton radiation for WHO Grade I-III meningiomas and emangiopericytomas.

BSI-201 (Iniparib)

Phase II study of the poly (ADP-ribose) polymerase-1 (PARP-1) inhibitor BSI-201 (iniparib), temozolomide in patients with newly diagnosed malignant glioma.

Vorinostat

Phase I/II study of Vorinostat (suberoylanilide hydroxamic acid [SAHA]), temozolomide, and radiation therapy in tatients with newly diagnosed glioblastoma.

Bevacizumab

A randomized phase II trial of concurrent bevacizumab and re-irradiation versus bevacizumab alone as treatment for recurrent glioblastoma.

Normal Pressure Hydrocephalus (NPH)

Endoscopic Third Ventriculostomy for Normal Pressure Hydrocephalus

Traditionally, patients with NPH have undergone surgery using a ventriculoperitoneal (VP) shunt. A VP shunt is a small drainage tube placed in the right ventricle (fluid-filled cavity) of the brain to remove cerebrospinal fluid (CSF, the fluid that surrounds the brain and spinal cord).

The purpose of this study is to see if a different type of surgical procedure, called endoscopic third ventriculostomy surgery (ETV) has better outcomes than VP shunt surgery for patients with NPH.

A total of 20 patients will be enrolled in this single-site pilot study at the University of Pennsylvania.

Spinal Fusion

Transforaminal Lumbar Interbody Fusion

Approximately 100 patients will be enrolled in this study across 4 sites in the United States. The University of Pennsylvania anticipates enrolling 20 patients.

The purpose of this study is to look at the effectiveness of a minimally invasive (smaller incision) versus an open (larger incision) surgical approach, for patients with lumbar stenosis, a narrowing of the spaces in the spine, resulting in pressure being applied to the nerve roots or spinal cord. The analysis also includes assessment of quality of life before and after surgery.

Severe Brain Injury

Traumatic Brain Injury Tissue Bank

The purpose of this study is to better understand the cellular, biochemical, and molecular events that occur after traumatic brain injury through the collection and analysis of blood, cerebral spinal fluid, and urine. This study also aims to evaluate the usefulness of thromboelastography (TEG), a blood test that rapidly generates blood clotting trends and allows for analysis of clotting function over time.

Neuro Intensive Care Unit-Based Studies

TVSH: Thromboembolism and Vasospasm in Subarachnoid Hemorrhage

The purpose of this study is to follow patients with subarachnoid hemorrhage, collecting blood and cerebral spinal fluid samples in order to examine the body's ability to form blood clots. The study also utilizes thromboelastography (TEG) blood tests to see if the body's cells are more likely to form clots after subarachnoid hemorrhage, with the hope of being able to better recognize patients at risk for stroke following this kind of injury.

PbtO2 CirQlator: The Effect of Intrathoracic Pressure Regulation Therapy on Regional Brain Oxygen Tension (PbtO2) in Patients with Severe Brain Injury

This research initiative examines the effect of negative sub-atmospheric intrathoracic pressure on regional brain oxygen tension (PbtO2) as measured using the Licox probe. The CirQlator Intrathoracic Pressure Regulator is a device that interfaces with the airway of a patient with a mechanical ventilator.

CnICP: An exploratory Study Comparing Non-Invasive Carotid Artery Pulse Wave Form Based Estimates of Intracranial Pressure (ICPCheck) to Gold Standard Invasive Monitoring ICP Results in Patients Undergoing Invasive ICP Monitoring

This is an observational study aimed at gathering information to determine the range of inter-patient variability of carotid artery pulse wave data compared to invasive ICP readings. Non-invasive carotid artery pulse wave form-based estimates of ICP will be studied in comparison to gold standard ICP monitoring ICP results.