Focused Ultrasound Foundation

Brain Program

Program Rationale:

Brain disorders represent a highly crucial treatment area for MR-guided FUS. Key reasons are: 1) these conditions are the most devastating and debilitating ailments afflicting humanity and are increasing in prevalence; 2) clinically, the brain is the most difficult organ to treat safely and effectively, and success of MR guided FUS in this segment will be viewed as proof of its ability to treat other organs; 3) from a societal perspective, the brain is a high-profile topic—there is widespread fascination with its workings and fear of its disorders. Successful, new treatments of brain disorders are likely to attract public interest and increase investment in other MR-guided FUS applications.

Workshops:

The Focused Ultrasound Surgery Foundation assisted in defining a comprehensive R&D roadmap for brain applications by organizing an invitation-only workshop in March 2009. Attended by thought leaders from industry, academia and the NIH, the workshop produced a roadmap of technical, preclinical, and clinical studies needed to escalate development of neurological applications. It also laid the groundwork for collaborations between manufacturers and academic research laboratories. A follow on workshop was in held March 2010 at the request of the first workshop participants and was central to further refinement of the brain program’s clinical and technical research roadmaps.

You can find the Brain Workshop 3 Whitepaper here.

The Brain Program has gotten off to a strong start and now encompasses a robust infrastructure. Components include:

• Brain Advisory Committee
• Data Safety Monitoring Board
• Clinical Trial Steering Committees for Brain Tumors and Movement Disorders (such as Essential Tremor and Parkinson's Disease)
• Core Imaging Laboratory
• Research Working Groups for Intracerebral Hemorrhage, Ischemic Stroke, and Neuromodulation

Brain Advisory Committee

The Brain Program Advisory Committee provides advice and counsel to the Focused Ultrasound Surgery Foundation (FUSF) Brain Program team on both research and development (R&D) and program activities.

Membership

• Neal F. Kassell, MD, Chairman, Professor of Neurosurgery, University of Virginia, Charlottesville, VA
• Ferenc Jolesz, MD, B. Leonard Holman Professor of Radiology & Vice Chairman for Research, Brigham & Women’s Hospital, Harvard Medical School, Boston, MA
• Dade Lunsford, MD, Lars Leksell Professor & Distinguished Professor of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA
• Edward Oldfield, MD, Professor of Neurosurgery and Internal Medicine, University of Virginia Medical Center, Charlottesville, VA
• Jacques Souquet, PhD, CEO, Supersonic Imagine, Aix-en-Provence, France
• Mickael Tanter, PhD, Laboratoire Ondes et Acoustique, E.S.P.C.I, Paris, France
• Eyal Zadicario, BSc, MSc, Director of Neurological Programs, Insightec, Tirat Carmel, Israel

Data Safety Monitoring Board

The DSMB is charged with monitoring adverse event (AE) data from the pilot clinical trials for MR-guided FUS for brain disorders sponsored by industry leaders.  The DSMB will conduct an independent, objective review of all AEs to assess their relationship to MR-guided FUS or the procedure.  Based on this review the DSMB will advise the sponsor on the appropriateness of continuing the clinical trials as designed.

Membership

• Howard M. Eisenberg, MD, Chairman, R.K. Thompson Professor and Chairman, Department of Neurosurgery, University of Maryland School of Medicine and Medical Systems, Baltimore, MD
• William G. Bradley, MD, PhD, FACR, Chairman and Professor of Radiology, University of California at San Diego, San Diego, CA
• Robert Grossman, MD, Chair of Neurosurgery, The Methodist Hospital, Houston, TX

Steering Committees

The Foundation brings together investigators and other key individuals in a collaborative setting that crosses medical disciplines in order to provide oversight and direction to pilot clinical studies for the Brain Program.  The goal of these clinical trials is to demonstrate the feasibility and safety of MR-guided FUS for the treatment of various indications in the brain.  The resulting data from these early clinical trials will be used to support the development of definitive safety and efficacy trials for submission and approval to the appropriate regulatory agencies and ministries of health as well as to support the needs of the medical and scientific community.

• Edward H. Oldfield, MD, Chairman, Professor of Neurosurgery and Internal Medicine, University of Virginia Medical Center, Charlottesville, VA
• Jason Sheehan, MD, PhD, Principal Investigator, Associate Professor of Neurological Surgery, University of Virginia, Charlottesville, VA
• Javier Fandino, MD, Associate Professor, Department of Neurosurgery, Universities of Berne and Zurich, Switzerland; Vice-Chairman, Department of Neurosurgery Kantonsspital Aarau, Aarau, Switzerland
• Ferenc Jolesz, MD, B. Leonard Holman Professor of Radiology & Vice Chairman for Research, Brigham & Women’s Hospital, Harvard Medical School, Boston, MA
• Todd Mainprize, MD, Assistant Professor, Division of Neurosurgery, University of Toronto, Toronto, Ontario, Canada
• David Schiff, MD, Professor of Neurology, University of Virginia Medical Center, Charlottesville, VA
• James C. Torner PhD, Professor and Chairman, Department of Epidemiology, University of Iowa, Iowa City, IA
• J. Pablo Villablanca, MD, Associate Professor of Radiology, Section Chief, Diagnostic Neuroradiology, David Geffen School of Medicine at UCLA, Los Angeles, CA

• G. Frederick Wooten Jr., MD, Chairman, Professor of Neurology, UVA Medical Center, Charlottesville, VA
• William Jeffrey Elias, MD, Principal Investigator, Associate Professor of Neurological Surgery and Neurology, UVA Medical Center, Charlottesville, VA
• Antonio DeSalles, MD, PhD, Director of Functional Neurosurgery, UCLA Medical Center, Los Angeles, CA
• Daniel Jeanmonod, MD, Center of Ultrasound Functional Neurosurgery, Solothurn, Switzerland
• Andres Lozano, MD,  PhD, Professor of Surgery (Neurosurgery), Ron Tasker Chair of Stereotactic and Functional Neurosurgery, University of Toronto, Ontario, Canada
• James C. Torner PhD, Professor and Chairman, Department of Epidemiology, University of Iowa, Iowa City, IA