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The Focused Ultrasound Surgery Foundation and Department of Neurosurgery at the University of Virginia hosted a Brain Workshop for Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) March 23-25, 2009 at a retreat in Chantilly, VA. The primary objective of the workshop was to develop a comprehensive R&D roadmap that would fast-track the use of this technology to treat a variety of brain disorders including benign and malignant tumors, Parkinson's disease and essential tremor, stroke, and epilepsy.

Participation was by invitation only, and representatives from academia, industry, NIH, and the Focused Ultrasound Surgery Foundation were in attendance. Participants included 45 leading neurosurgeons, neurologists, neuroradiologists, neuroscientists, biomedical engineers, physicists, product-development managers and medical device company executives from around the world.

Pre-work in the form of online surveys, review articles, and brain disease summaries was used by the participants to help identify and prioritize clinical and technical issues for discussion.

The group consensus was to prioritize:

  • movement disorders (Parkinson's Disease, Essential Tremors, and Dystonia)
  • meningiomas
  • metastatic brain tumors
  • stroke
  • epilepsy

The results of the workshop will be communicated in a White Paper and include the outline of a comprehensive R&D roadmap, the current best treatment for these conditions, an actionable short-term plan for technology development, preclinical studies, and pilot clinical trials including the identification and prioritization of clinical indications to be addressed, technologies required to treat these indications, and sites where the research will be performed.

The workshop also enabled the creation of a collaborative research environment and structure that will enable rapid execution of this plan and accelerate the development and adoption of focused ultrasound surgery for treating a variety of disorders of the brain.

Primary Objectives of the Brain Workshop

  1. Develop an outline of a preliminary comprehensive Research & Development (R&D) plan leading to reimbursable treatments and a quantum improvement in the management of a wide spectrum of intracranial pathologies (including benign and malignant tumors, Parkinson's disease and essential tremor, stroke, and epilepsy).
  2. Develop an actionable plan leading to pilot clinical studies that could be completed in 1-2 years for several indications that will provide proof of concept and validate the field.
  3. Create enthusiasm and establish momentum that will serve as a foundation for rapid growth.
  4. Establish guidelines for allocating foundation resources.  We want to invest around $10M into brain research over the next three years.

The Program

Participation consisted of 64 thought leaders from industry, academia, the NIH and the Focused Ultrasound Surgery Foundation. Participants included 18 neurosurgeons, 5 neurologists, 5 neuroradiologists, 14 biomedical engineers and Radiology PhDs, and 22 other scientists, product-development managers and medical device 

The first session was comprised of state-of-the-art presentations from experts in the field:

  1. Thalamotomy for neuropathic painDaniel Jeanmonod, Ernst Martin, (Zürich)
  2. Brain tumorsFerenc Jolesz (Brigham & Women's)
  3. Intracerebral / Intraventricular hematomaSagi Harnof  (Sheba)
  4. Acute Ischemic StrokeThilo Hoelscher (UCSD)
  5. Blood brain barrier openingNathan McDannold (Brigham & Women's)
  6. Neuromodulation Alexander Bystritsky (UCLA)
  7. Jamie Tyler (Arizona State)
  8. Seung-Schik Yoo (Brigham & Women's)

 The second set of presentations comprised of technology reviews and updates from experts and industry: 

  1. Fundamentals of Brain MRgFUS Ferenc Jolesz 
  2. Supersonic ImagineClaude Cohen-Bacrie 
  3. Philips HealthcareAri Partanen  
  4. InSightecEyal Zadicario

There were also several reports from discussion groups on specific subjects. These were followed by facilitated discussions using a framework based on the online survey results. An outline research roadmap for the priority indications was defined by the group. 

Specific breakout sessions planned on the first day (for simulations and neuromodulation) were followed the next two days with additional specific workgroups that evolved during the active meeting discussions (in movement disorders, neuromodulation follow up, animal models and a technical workgroup assessing “ringing” and “standing waves” within the skull).  A forum for informal discussions was provided each evening in the form of receptions and dinners.

A facilitator with prior experience running such workshops was hired to expedite the process and keep sessions on time.  Specialist expert panels, including the primary discussants, were assembled for each section to provide summary discussions and conclusions. 

Being a closed meeting, the workshop facilitated collaboration and discussion.  It was an iterative process, wherein discussion proceeded towards a general consensus among the experts. The mix of clinicians and engineers provided a basis for improving the technology to support the projected clinical indications.

Extensive pre-work in the form of 3 online surveys, review articles, and brain disease summaries were distributed to the participants to help identify and prioritize clinical and technical issues for discussion.  After reviewing the key papers participants completed an online survey, which had two sections. Firstly, to apply a weighting score to a list of criteria used to decide which indications should be given priority. These criteria included an assessment of unmet need, and expected overall impact. The group consensus was to prioritize movement disorders, meningiomas, metastatic brain tumors, stroke and epilepsy. Secondly, after ranking the priority indications, participants applied weighting scores to potential technical research areas for each indication.

 

Metrics of Success for the Brain Workshop

Dr. Neal Kassell outlined the Metrics of Success during his opening remarks:

  1. Will we have answered the burning questions?  Undoubtedly we will develop new questions.
  2. Develop an outline of a comprehensive R&D roadmap.
  3. Develop an actionable plan leading to pilot clinical studies for several indications that can be completed in 12-24 months.
  4. Established a structure and environment for collaboration that will allow rapid execution of this plan.

He also outlined the diverse agendas envisioned for the groups represented:

  1. Industry - creates value through productivity and quality. Better treatments for large numbers of patients. No more noble way to make money than to save lives and relieve suffering.
  2. Academic community - searching for glory derived from discoveries.
  3. Foundation - Mission is to develop new applications for and accelerate the global adoption of FUS.

Collaboration and cooperation in the digital era are critical to this effort. We want to amalgamate investigators and facilities in a boundary-less model.  There is no room to duplicate efforts when there is so much work to be done.

The workshop also enabled the creation of a collaborative research environment and structure that will enable rapid execution of this plan through the synthesis of investigative efforts in academia and industry and linkage to funding sources.  This will accelerate the development and adoption of focused ultrasound surgery for treating a variety of disorders of the brain.

In addition to fulfilling the specific ives related to focused ultrasound surgery and the brain, the workshop established a contemporary model for accelerating the development of large-scale therapeutic modalities.

Priority Clinical Indications

During the pre-work phase participants were asked to prioritize the potential clinical indications from a list of 17 possible brain disorders where focused ultrasound has potential. After being provided with background information on each indication, the participants were asked to score the relative importance of each indication using the online survey method. This process took into account a range of factors so that indications were not selected solely on the basis of prevalence. 

Those indications which were prioritized are Bold and underlined: 

  1. Metastatic Tumors
  2. Cavernomas (cerebral cavernous malformations)
  3. Gliomas
  4. Pituitary macroadenomas
  5. Pituitary micro-adenomas
  6. Acoustic Neuromas (Vestibular Schwannomas)
  7. Meningiomas
  8. Chordomas
  9. Intracerebral and Intraventricular hemorrhage
  10. Ischemic Stroke
  11. Arteriovenous Malformations (AVMs) 
  12. Epilepsy - Mesial Temporal Lobe Sclerosis 
  13. Movement Disorders
  14. Trigeminal Neuralgia (Tic Douloureux)
  15. Neuropathic Pain 
  16. Alzheimer's Disease
  17. Psychiatric Disorders

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