Neurology Clinical Trials and Research

The following is information about the ongoing clinical trials and research that may be of interest to those treating individuals with neurological disorders.

Grants

• SMHS Center for Faculty Excellence, Virtual Reality to Enhance Gross Anatomy Education in Graduate and Medical Student Programs, 2019 – 2021, Total Award $9,990 (PI-Sherman, co-PI-Brown)

• Plasma Medicine Initiative, US Patent Innovations Inc., 2017 – 2022, Total Award $5.3 million (PI-Keidar, Co-PI-Sherman)

• National Science Foundation (NSF), Industry University Cooperative Research Centers (IUCRC), 2018 – 2023, Center for High Pressure Plasma Energy, Agriculture, and Biomedical Technologies (PEAB), $750,000 (NSF), (PI-Keidar, Co-PI-Sherman)

• GW Institute for Biomedical Engineering Interdisciplinary Research Fund, Cold Atmospheric Plasma as a Novel Therapeutic Approach for Glioblastoma, Examine the Therapeutic Potential of CAP for Cancer Treatment in a Xenograft Murine Model of GBM, 2015 – 2016, Funding $20,000

• Katzen Cancer Research Center Innovative Cancer Pilot Research Study Grant, Cold Atmospheric Plasma in the Treatment of Malignant Glioma, 2013, Funding $60,000

Clinical Sponsored Trials

• National Institutes of Health (NIH/NIMHD) U54 African American Cardiovascular Pharmacogenetic Consortium (ACCOuNT), Sub-award: "Comparative Analysis of Platelet Genomics in European- and African-Americans with Thrombotic Disease," PI: Travis O’Brien 

• Randomized, Multi-center, Phase 2 Study of DSP-7888 in Combination with Bevacizumab versus Bevacizumab Alone in Patients with Recurrent or Progressive Glioblastoma Following Initial Therapy, Enrolling

• Multi-center Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignancy in Patients with Newly Diagnosed or Recurrent Malignant Glioma: A Safety, Histopathology, and Correlative Biomarker Study, March 2018 – January 2019

• A071401: Meningioma (Alliance): Phase II Trial of Smo/AKT/NF2 Inhibitors in Progressive Meningiomas with SMO/AKT/NF2 Mutations

• BBI-DSP7888-20G: A Randomized, Multi-center, Phase 2 Study of DSP-7888 Dosing Emulsion in Combination with Bevacizumab versus Bevacizumab Alone in Patients with Recurrent or Progressive Glioblastoma Following Initial Therapy

• GWIRB #121624: 5ALA: A Multi-center Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor in Patients with Newly Diagnosed or Recurrent Malignant Gliomas: A Safety, Histopathology, and Correlative Biomarker Study

• GWIRB #040855: HUD: Codman Enterprise Vascular Reconstruction Device and Delivery System

• GWIRB #031437: HUD: Wingspan Stent System with Gateway PTA Balloon Catheter

• GWIRB #111239: Low Frequency Electrical Stimulation of the Fornix in Intractable Mesial Temporal Lobe Epilepsy (MTLE)

• GWIRB #51810: Multi-institutional Study Assessing Pediatric and Adult Chiari 1 Malformation Surgery

• GWIRB #101421: HUD: Deep Brain Stimulation for Treatment Resistant Dystonia

• GWIRB #04855: HUD: Neuroform Atlas Stent

• GWIRB #031437: HUD: Wingspan Stent System with Gateway PTA Balloon Catheter

• Invest Feasibility: A Single Arm, Feasibility Study of Minimally Invasive Endoscopic Surgical Treatment with Apollo/Artemis for in Supratentorial Intracerebral Hemorrhage (ICH)

• Invest Registry: Minimally Invasive Endoscopic Surgical Treatment with Apollo/Artemis in Patients with Brain Hemorrhage: A Prospective Multi-center Registry

• A Prospective, Multi-center Study of Artemis, a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage

Investigator Initiated Trials

• Neuro-oncology Tumor Specimen Bank, July 2012 – Present

• Neuro-oncology Registry, July 2012 – Present 

• Role of FoxJ1 in the Treatment of Glioblastoma, March 2016 – June 2018

Research

The George Washington University
Winter 2019 – Present 
Research in conjunction with Kirsten Brown, PhD
Research studying the role of virtual reality to enhance gross anatomy education in graduate and medical student programs.

The George Washington University
Spring 2017 – Present
Research in conjunction with Ramin Javan, MD, Keith Mortman, MD and Neil Sikka, MD
Development of an Innovations Institute George Washington University.

The George Washington University and Department of Defense
Spring 2018 – Present
Research in conjunction with James Hahn, PhD 
Development of a low cost, portable versatile simulator with haptic feedback.

The George Washington University
Spring 2012 – Present
Research in conjunction with Michael Keidar, PhD
Researching the use of cold atmospheric plasma technology in the treatment of malignant glioma.

Past Projects

• Assessment of Brain Tumor Tissue Oxygenation Levels in Patients with Malignant Glial Neoplasms, July 2012 – June 2015

• Assessment of Recurrent Metastatic Cancer Using Cold Atmospheric Plasma, May 2016 – December 2017

• Phase 3, Randomized, Controlled, Double-Arm, Open-Label, Multi-center Study of VB-111 Combined with Bevacizumab vs. Bevacizumab Monotherapy in Patients with Recurrent Glioblastoma, June 2016 – December 2016

• Phase 1/2 Study of SL-701, a Subcutaneously Injected Multivalent Glioma – Associated Antigen Vaccine, in Adult Patients with Recurrent Glioblastoma, Protocol STML-701-0114, September 2014 – September 2016

• Duraseal Exact Spine Sealant System Post-Approval Study, Protocol COV-DRSS-0002, February 2012 – December 2015

• Open-label Phase 1/2 (Safety Lead-in) Study of Trans Sodium Crocetinate (TSC) with Concomitant Treatment of Fractionated Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma Patients to Evaluate Safety and Efficacy, Protocol 100-202, February 2012 – June 2013

• The George Washington University, Department of Pharmacology and Physiology, Research in Conjunction with Anthony LaMantia, PhD, Characterization of the Forkhead Gene FOXJ1 as a Biomarker in Glioblastoma​, Spring 2011 – Spring 2018

• The George Washington University and Children’s National Medical Center, Research in Conjunction with Javad Nazarian, Researching the Role of FoxJ1 as a Biomarker in DIPG​, Fall 2017 – Spring 2018

• The George Washington University, Neurosurgery Department, Research in Conjunction with Dr. Michael Keidar, Research Analyzing Excitation and Control of Neural Fiber Activity in a Weak Non-thermal Microwave Field, Winter 2015 – Spring 2018

• The George Washington University, Department of Pharmacology and Physiology, Research in Conjunction with Dr. Anthony LaMantia and Dr. Sally Moody, Characterization of Neural Precursor Cells in Glioblastoma: Developing New Treatment Targets, Spring 2011 – Spring 2018

• The George Washington University, Department of Pharmacology and Physiology, Research in Conjunction with Dr. Anthony LaMantia and Dr. Sally Moody, Researching the Role of FoxD4 on Murine Neuronal Differentiation, Fall 2011 – Fall 2017

• The George Washington University, Neurosurgery Department, Research in Conjunction with Dr. Ferid Murad, Researching the Effects of Combination Phospohdiesterase-5 Inhibitor and Brain Naturetic Peptide on Glioma Progression, Fall 2011 – Spring 2012