Department of Neurosurgery

Patients at Penn Neurosurgery can benefit from a variety of breakthrough clinical trials that can help improve the quality of life for those with neurological disorders. 

Ever wonder what a clinical trial is? This video will help explain some of the ins and outs of one of the most important steps of modern medical research.

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

Movement Disorders

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.

Principal Investigator: Gordon Baltuch, MD, PhD

Glioblastoma Multiforme and Other Brain Tumors

DCVAX-L and DCVAX-EA

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

Principal Investigator: Steven Brem, MD

CDX110-05 Compassionate Use Protocol

A study of rindopepimut/GM-CSF in patients with newly-diagnosed or relapsed, EGFRvIII-positive glioblastoma.

Principal Investigator: James Schuster, MD, PhD

Proton/Photon Radiotherapy

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

Principal Investigator: Michelle Alonso-Basanta, MD, PhD

Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma

This study is open to patients who are at least 6 months following initial treatment for glioblastoma with radiation and chemotherapy and have recurred. The area that needs to be treated should be 6cm or less. Patients will be randomized to Avastin alone or Avastin plus radiation which will consist of 10 radiation treatments. Proton beam radiation will be used if approved by the patient's insurance company.

Principal Investigator: Robert Lustig, MD

Brain Tissue for Single Cell mRNA Variation

For patients undergoing epilepsy surgical resection, tumor resection, and NPH requiring placement of a shunt catheter, collection of cortical tissue to generate the mRNA expression profile of human neurons and compare to corresponding phenotype and electrophysiological data.

Principal Investigator: M. Sean Grady, MD

Penn Neurosurgery – CHOP Tumor Tissue Bank

Collection and banking of tumor tissue and blood as a resource for research aimed at obtaining a better understanding of the molecular genetic events that cause initiation and progression of nervous system tumors.

Principal Investigator: Donald O'Rourke, MD

Phase 2, Open-Label, Imaging Trial of I-124-CLR1404 in Patients with Newly Diagnosed or Recurrent Glioblastoma

This study will test a new agent, I-124-CLR1404, that could be used in scanning patients with brain cancer. Patients who have been diagnosed with brain cancer (glioma) that is new or has returned after standard therapy and will be having surgery or a biopsy will be asked to participate in this study. This agent allows cancer cells to be seen by radiology scanning equipment. This research is being done to help us determine the best dose of the study drug and ideal timing of the scans.

Principal Investigator: Abass Alavi, MD

Neuro-Imaging Studies

Intraoperative Imagery of Solid Tumors with Indocyanine Green

Our specific aim is to determine if ICG administered pre-operatively, then imaged intraoperatively using our camera will aid in the identification of suspected nodules tumor, margins, lymph nodes and satellite nodules tumors in various regions of the body.

Principal Investigator: John Lee, MD

Multishell

Whether edema-invariant msHARDI tractography allows accurate white matter fiber reconstruction in conjunction with a Cognitive Neuro-Psych Battery.

Principal Investigator: Steven Brem, MD

High resolution MRI and MRS to Evaluate Therapeutic Response to Novo-TTF in Brain Tumors

Imaging study using advanced Magnetic Resonance Imaging (MRI) techniques to evaluate brain tumors and treatment response from Novo-TTF (Optune) treatment therapy.

Advanced MRI techniques such as DTI, MR Perfusion and MR Spectroscopy may help assess treatment response earlier than changes in tumor volume which can be measured with standard MRI methods.

Principal Investigator: Suyash Mohan, MD

Spinal Studies

Dynesys 522

A prospective non-randomized study to assess the safety profile and fusion rates following posterior lateral fusion with the Dynesys Spinal System as an adjunct to fusion compared to a literature control.

Principal Investigator: William C Welch, MD

Degenerative Disc Tissue Bank

Collection and banking of tissue from many histopathologic subsets of spinal disc degeneration as a resource for research aimed at understanding the molecular genetic events that cause initiation and progression of degenerative disc disease.

Principal Investigator: Neil Malhotra, MD

Trigeminal Neuralgia

Finding Genes that Predispose to Trigeminal Neuralgia

The purpose of this study is to find out if classic trigeminal neuralgia (TN 1) has a genetic component and understand the inheritance of trigeminal neuralgia. This is a prospective study that will involve the collection of a saliva sample, storage and subsequent DNA analysis.

Principal Investigator: John Lee, MD

Long-Term Follow-up of Surgically-Evaluated Patients with Trigeminal Neuralgia: A Systematic Comparison of Treatments and Control

Trigeminal neuralgia (TGN): disorder consists of shooting, intermittent, overwhelming facial pain. Treatments include: medication; gamma knife radiosurgery (GKS); & microvascular decompression (MVD). Present studies do not provide evidence necessary to identify the most therapeutic treatment for TGN that cannot be managed by medication. By collecting info from patient TGN evaluation and comparing outcomes of MVD, GKS, & no intervention, the treatment with better patient outcomes can be identified

Principal Investigator: John Lee, MD

Epilepsy

Epilepsy Research Collaborative

A comprehensive analysis of patients with medically refractory seizures focused on improving medical management and care through the analysis of (1) advanced brain imaging, (2) effects of anesthetic on EEG, (3) grid registration, (4) brain computer interface algorithms, and (5) continuous iEEG data.

Principal Investigator: Timothy Lucas, MD, PhD

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.

Principal Investigator: M. Sean Grady, MD

NeuroCritical 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.

Principal Investigator: Sherman Stein, MD

RISCIS

Evaluation of the efficacy and safety of riluzole in the treatment of patients with acute spinal cord injury. Secondary objectives are to evaluate the effects of riluzole on overall neurologic recovery, sensory recovery, functional outcomes, quality of life outcomes, health utilities, mortality and adverse events.

Principal Investigator: James Schuster, MD, PhD

SAGE-547

An open-label study of SAGE-547 Injection in adult patients diagnosed with SRSE who are undergoing therapy with a continuous IV infusion of an AED (third-line agent) ≥ 24 hours, but have not achieved an electroencephalographic state of seizure-suppression.

Principal Investigator: Joshua Levine, MD

Share This Page: