The faculty of the Department of Neurological Surgery at Northwestern University Feinberg School of Medicine believe that research plays a critical role in the advancement of care. Learn more about the innovative research projects in each of our medical specialties.
- MISTIE III (Minimally Invasive Surgery Plus rt-PA for ICH Evacuation Phase III)
PI: Babak S. Jahromi, MD, PhD
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
The purpose of this study is to test a minimally invasive, catheter-based surgical procedure with administration of a drug called rt-PA (recombinant tissue plasminogen activator) as a treatment for intracerebral hemorrhage (ICH) to break up and remove blood clot. Subjects enrolled in this study are randomized to one of two study groups—standard medical treatment (no surgery or study drug) or surgical treatment. Follow-up is for one year to determine if the surgical procedure and rt-PA help patients recover more fully compared to standard medical treatment. Study candidates must be 18-80 years of age and diagnosed with certain types of ICH.
FRED (Pivotal Study of the MicroVention Flow Re-Direction Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms)
PI: Sameer A. Ansari, MD, PhD
Sponsor: MicroVention, Inc.
The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Re-Direction Endoluminal Device (FRED) stent system when used in the treatment of wide-necked intracranial aneurysms. Study candidates must be 22-75 years of age with a diagnosis of a wide-necked intracranial aneurysm located in the internal carotid artery.
HEAT (New Generation Hydrogel Endovascular Aneurysm Treatment Trial)
PI: Sameer A. Ansari, MD, PhD
Sponsor: MicroVention, Inc.
The purpose of this post-market clinical trial is to compare the effectiveness of the FDA-approved 2nd Generation HydroCoil© Embolic System with the current standard device for endovascular intracranial aneurysm treatment which is bare platinum coils. Subjects enrolled in this study are randomized to one of two study groups for each device with both groups receiving the same standard of care and follow up.
STARRT (Evaluation of Targeted Radiofrequency Ablation and Vertebral Augmentation prior to or following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumors)
PI: Sameer A. Ansari, MD, PhD
Sponsor: DFINE, Inc.
The purpose of this study is to evaluate the treatment of painful metastatic lesions in vertebral bodies with pathologic fractures using targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following radiation therapy. Study candidates must be 18 years of age or older with diagnosis of metastatic spinal tumor and experiencing pain.
- Early Surgery for Intractable Epilepsy (ERSET trial)
The purpose of this phase three trial is to compare the effectiveness of early functional neurosurgery intervention for mesial temporal lobe epilepsy to continued treatment with antiepileptic drugs.
- Comparison of Senza to Commercial Spinal Cord Stimulation for the Treatment of Chronic Pain
The purpose of this investigational neuromodulation study is to establish the safety and effectiveness of electrical stimulation delivered to the spinal cord in subjects with chronic, intractable pain and will be a comparison of the Senza System with commercially available SCS systems.
- A Randomized, Double-blind, Controlled Phase IIb Study of the Safety and Efficacy of ICT-107 in Newly Diagnosed Patients with Glioblastoma Multiform Following Resection and Chemoradiation
ICT-107 is an autologous vaccine consisting of the patient’s dendritic cells pulsed with six synthetic tumor-stem cell associated antigens: AIM-2, MAGE-1, TRP-2, gp100, HER-2, IL-13Rα2 while the Control consists of the patient’s unpulsed dendritic cells. The purpose of the study is to compare overall survival (OS), progression-free survival (PFS) and safety and tolerability of ICT-107 in patients treated with the vaccine versus the Control arms. This study will also describe the immune response in patients treated with ICT-107 and determine predictors of response.
- Molecular Profiling Project of Glioma diseases
This project is looking into identifying genome-based alterations in glioblastomas, astrocytomas, oligodendrogliomas which are the majority of the glioma diseases collected. The purpose of this neurosurgical oncology study is to identify specific genes that are altered in each individual sample (ex: profile of genetic aberrations of each tumor). Glioma patients’ CNV gene profiles with specific clinical data will be clustered into several groups. Principal Component analysis, Survival analysis, multivariate multiple regressions will be used to find the potential connections between the featured groups.
- An Observational Study to Quantify and Predict Tumor Growth and Response to Therapy in Brain Tumor Patients
This research project is designed to investigate how mathematical modeling techniques can be applied to clinical data to improve patient care through non-invasive computer simulations of tumor growth and response to therapy on a patient-specific basis. We perform detailed image analysis on each patient’s clinical images so that we can parameterize our mathematical models and compare our models’ predictions with progress observed clinically via existing medical images. Through this work we have shown that mathematical models tuned to individual patient growth patterns can be used to better understand how brain tumors grow and respond to therapy.
- A Post-Approval Investigation of the BRYAN® Cervical Disc Device at a Single Level for Symptomatic Cervical Disc Disease
Long-term performance of the BRYAN® Cervical Disc in the treatment of patients with cervical degenerative disc disease (PI: Fessler)
- Long Term Follow-Up of Subjects Who Received GRNOPC1 [Protocol CP35A008]
Long-term follow up of subjects with neurologically complete, traumatic, thoracic, spinal cord injury, who received administration of GRNOPC1 under clinical study protocol CP35A007 (PI: Fessler)
- A Multicenter Prospective Study of Quality of Life in Adult Scoliosis
This multi-center study is the first of its kind to evaluate the effectiveness of non-operative and operative treatments in adults with symptomatic lumbar scoliosis (ASLS). Investigators are also evaluating the impact of patient factors (age, gender, socioeconomic status, education) and co-morbidities [mental health, body mass index (BMI) and bone mineral density (BMD)] on adverse events and treatment outcomes for both the non-operative and operative arms.
- Proximal Junctional Kyphosis (PJK) and Proximal Junctional Failure (PJF) Following Spinal Arthrodesis; Evaluation, Prevention and Treatment Strategies
Sponsored by: International Spine Study Group Foundation (ISSGF)
The purpose of this multi-center project is to gain a better understanding of the clinical and radiographic characteristics that encompass the spectrum of PJK and differentiate the benign forms of junctional kyphosis from the severe, incapacitating forms of junctional kyphosis (termed proximal junctional failure; PJF).
- DuraSeal™ Exact Spine Sealant System Post-Approval Study (Protocol # COV-DRSS-0002)
Sponsored by: Covidien
This is a multi-center, non-randomized, post-approval study to further evaluate the rate of post-operative CSF leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant for treatment of either an intentional or incidental opening of the dura as compared to Control patients who receive other products and/or treatments to close the dura.
- Cranial Cervical Balance Study
Sponsored by: Medtronic
The purpose of this single-institution study is to evaluate spinal alignment in 100 asymptomatic adults across 3 age categories: 20-40, 40-60, and 60-80. This study also examines the relationship of the cranial center of mass to the spine in order to define the true importance of the head in determining global sagittal balance.
- Pediatric Brain Tumor Consortium Clinical Trials
The PBTC Consortium is a multidisciplinary cooperative research organization devoted to the study of correlative tumor biology and new therapies for primary CNS tumors of childhood.
- A Phase I Study of AdV-tk + Prodrug Therapy in Combination with Radiation
This study will evaluate the administration of AdV-tk followed by valacyclovir in children with malignant glioma, including glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), as well as recurrent ependymomas in combination with radiation therapy. The primary objective is to determine if this approach is safe and can be effectively delivered without disturbing standard therapy.
- Collection and Banking of CNS Tumor Specimens for Biologic Research Studies
The purpose of this study is to collect and store brain tissue samples and blood from children with brain cancer that will be tested in the laboratory.
- Syringomyelia/Chiari National Database Registry