Current Clinical Trials
Dystonia
- Humanitarian Device Exemption (HDE) for Medtronic Activa. Dystonia Therapy (HDE# H0200007).
Brain Tumors
- HSPPC-96 PHASE 2, multi-center, open-label investigation of HSPPC-96 vaccine with temozolomide in patients with newly diagnosed Glioblastoma Multiforme
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HSPPC-96 is an autologous, tumor-derived heat shock protein (glycoprotein 96 or gp96)-peptide complex vaccine that is individually prepared from specimens of the patient's own tumor. Vaccine administration begins after tumor resection and chemoradiation.
- ICT-107 Phase 2, A Randomized, Double blind, Controlled Phase IIb Study of the Safety and Efficacy of ICT 107 in Newly Diagnosed Patients with Glioblastoma Multiforme Following Resection and Chemoradiation
ICT 107 is a DC vaccine designed to induce immunity capable of rejecting an established tumor, especially if the tumor is in a minimal residual state such as after complete surgical resection. The DCs that secrete IL 12 provided in ICT 107 are a potent vaccine adjuvant. In addition it has been shown that the antigens targeted by the peptides are expressed on GBM cells. By targeting multiple antigens with MHC Class I peptides that induce the T cell immune response most associated with clinical benefit, ICT 107 can prevent the emergence of antigen negative escape variants.
- Language Recovery in Brain Tumor Patients: Multi-modal evaluation of language network remodeling in brain tumor patients.
A total of 20 patients will be enrolled in this single-site pilot study at the University of Pennsylvania.
The overall objective of the proposed project 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.
Treatment for 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.
Spine Tumor
- Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression (MESCC): Quality of Life and Cost-Effectiveness Outcomes.
The purpose of this research study is to look at outcomes of treatment for surgical and non-surgical treatment for single, symptomatic, metastatic epidural spinal cord compression (MESCC).
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 to enroll 20 patients.
The purpose of this study is to look at the effectiveness of 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) and the quality of life before and after the procedure.
Severe Brain Injury
- ProTECT™ III: Progesterone for the Treatment of Traumatic Brain Injury.
A total of 1140 subjects will be enrolled from the 17 Neurological Emergencies Treatment Trials (NETT) Network Hub/Spokes (sites).
For patients to be eligible, the study drug must be able to be initiated within 4 hours of injury. Time for drug preparation will vary from site to site. In general, at least 20 minutes should be allowed for drug preparation.
- Sponsored by: NETT = "Neurological Emergencies Treatment Trials"
- Randomized Clinical Trial of the Safety and Efficacy of Brain Tissue Oxygen (pBrO2) Monitoring in the Management of Severe Traumatic Brain Injury.
The primary purpose of this study is to test the effectiveness of treatment to reduce the fraction of time that brain oxygen levels are below the critical threshold of 20 mm Hg.
- Sponsored by: NIH
- Validation of NIRS CBF with XeCTCBF.
The purpose of this study is to further evaluate an investigative device which is a non-invasive (outside the body) continuous brain blood flow monitor (NIRCBF) that measures changes in the flow of blood and oxygen in your brain during the period of time that you are most at risk for vasospasm (A narrowing of the artery in the brain that limits blood flow to the brain).
Individuals who are diagnosed with an aneurysmal subarachnoid hemorrhage (aSAH, a leak in an artery of the brain) or a traumatic brain injury may be eligible to participate in this research study.
- Sponsored by: NIH
- The use of the Bispectral Index Monitoring System to Detect Seizures in the Brain-Injured Patient: a Prospectively Collected Database.
The purpose of this study is to learn more about the role of the Bispectral analysis (BIS monitor, a sticker detector that reads brain waves from the forehead) in seizure detection. A BIS monitor will be placed and clinical data will be recorded for up to 10 days. This monitor will be compared to the occurrence of seizures with continuous electroencephalography [cEEG] monitoring.
