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.

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.

Advance Neuromodulation DBS

A 12-month double-blind, randomized, controlled feasibility study to evaluate the safety, efficacy and tolerability of deep brain stimulation of the fornix (DBS-f) in patients with mild probable Alzheimer's disease.

MEMES

The purpose of this research is to evaluate the feasibility of using direct deep brain recording and stimulation to improve the rate of learning and to the encoding and retrieval of memories in human subjects. Targeted population for this study is Parkinsons disease patients undergoing deep brain stimulation.

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.

CDX110-05 Compassionate Use Protocol

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

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.

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.

CAR-T in EGFRvIII+ Glioblastoma

Determine the safety and feasibility of using CART-EGFRvIII (autologous T cells transduced with a lentiviral vector to express a chimeric antigen receptor specific for EGFRvIII) in the treatment of glioblastoma.

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.

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.

Cranial Block

Assessment of the effectiveness of analgesia by scalp nerve block with various agents in their first 24 hours following elective craniotomy.

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.

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.

Advanced Imaging for Meningiomas

Imaging study to determine whether advanced imaging including diffusion, perfusion and MR spectroscopy can predict the histologic grade, tumor consistency and growth rate of meningiomas. This study also plans to validate diffusion and perfusion measurement with histology by directly correlating imaging findings with Ki67, microvessel density and collagen content from surgical samples.

HARDI MRI Sequencing

Integration of High Angular Resolution Diffusion Imaging (HARDI)-based tractography with intra-operative neuronavigation to determine the feasibility of integrating HARDI as an eventual surgical adjunct and reduce risk to eloquent brain regions.

Multishell

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

Retrospective Analysis of Diffusion-based Cerebral White Matter Tractography

Retrospective analysis of diffusion-based cerebral white matter tractography with the objective of characterizing cerebral white matter tracts in patients with brain lesions and analyzing the surgical, prognostic, clinical, and rehabilitation-associated significance of white matter tracts in patient's harboring brain lesions.

Advanced MRI Methods for Detecting Pseudoprogression of Glioblastomas

Imaging study using advanced MRI techniques for the evaluation of treatment response in patients with glioblastomas (GBM).

To determine whether a combination of diffusion tensor imaging (DTI) and MRI perfusion imaging parameters can distinguish GBM patients with true progression (TP) from mixed response and pseudo-progression (PsP).

Accurate identification of PsP from TP is critical as patients with TP may require a change in treatment strategy while those with PsP may not.

Advanced 7T MR Imaging and Spectroscopy of Brain Tumors

Imaging study to establish clinical utility of advanced MRI and MR Spectroscopy techniques on a 7 Tesla MRI scanner. (University of Pennsylvania is one of the few institutions around the world to have access to this level of technology).

To improve the non-invasive biochemical characterization of brain tumors in vivo, including detection of the oncometabolite 2-hydroxyglutarate (2HG) as a surrogate imaging biomarker for isocitrate dehydrogenase (IDH1) mutation.

In vivo 2HG detection by MR Spectroscopy will enable detailed molecular characterization of a clinically important subset of human gliomas, with implications for diagnosis as well as monitoring of targeted therapies.

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 Perfuion and MR Spectroscopy may help assess treatment response earlier than changes in tumor volume which can be measured with standard MRI methods.

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.

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.

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.

Long-term follow-up of surgically-evaluated patients with trigeminal neuroalgia: 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.

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.

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.

Neurointensive 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.

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.

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.