Nearly 80 leading scientists, researchers, public health officials and industry executives from 12 countries and 30 different institutions participated in the FUS Foundation’s third invitational Brain Workshop from October 23 to 26.

With 46 presentations on the agenda, this year’s workshop provided an in-depth progress report on the status of the Brain Program and the work ahead. As FUS Foundation Chairman Neal Kassell, MD told attendees, “Our primary interest is to rapidly advance the development and adoption of reimbursable applications that either fulfill an unmet clinical need or are significantly better than existing therapies in terms of outcomes, cost and convenience.”

In the spotlight at this year’s meeting was the essential tremor clinical trial at the University of Virginia. Spawned during the first Brain Workshop in 2009 and funded by the FUS Foundation, the 15-patient pilot study is nearing successful completion. It is considered a shining example of the fast-track progress that can be achieved by multi-disciplinary, collaborative working groups, which are a hallmark of the foundation’s Brain Program.  

This year’s Brain Workshop had three specific goals:

  1. Produce a white paper documenting the state-of-the-art of MR-guided focused ultrasound and the brain. That document will be circulated to Brain Workshop participants and posted on the foundation’s website in December 2011.
     
  2. Develop action plans for 2012-2013, including technical projects, preclinical studies, and clinical trials leading to reimbursable indications.
     
    • Essential Tremor – Develop a protocol for a multicenter, pivotal clinical trial that satisfies the requirements of the medical and scientific communities, the FDA and reimbursement organizations.
       
    • Parkinson’s Disease – Submit a pilot clinical trial protocol for FDA approval.
       
    • Brain Tumors – Develop new path forward to reach the goal of launching a pilot clinical trial for treating the whole intracranial volume. Keep plans for blood-brain barrier study on track.
       
    • Temporal Lobe Epilepsy – Continue preclinical investigation of feasibility and safety of treatment. Develop a dialog around a clinical treatment strategy for mesial temporal lobe epilepsy using focused ultrasound.
       
    • Ischemic Stroke – Rethink approach and chart a new direction that is beyond recanalizing a blocked artery. Investigate the use of unfocused ultrasound to treat the microcirculation in the ischemic region.
       
    • Intracerebral Hemorrhage – Draft a pilot clinical trial protocol while a preclinical study is being completed early next year.
       
  3. Create a collaborative environment and infrastructure to facilitate achieving the above initiatives as rapidly as possible.

During the workshop, participants created new working groups to complete several technical projects, including:

Treatment envelope expansion for temporal lobe epilepsy, brain tumors, etc. – Effective and efficient treatment of brain tumors will require a much larger treatment envelope than currently provided by the InSightec ExAblate 650KHz brain system. The enlarged envelope will need to encompass the entire intracranial space, if possible.

Leader: JF Aubry, PhD (Institut Langevin); Working Group: Arik Hananel, MD (FUS Foundation), John Snell, PhD (FUS Foundation), Matthew Eames, PhD (FUS Foundation), Kullervo Hynynen, PhD (Sunnybrook), Thilo Hoelscher, MD (UCSD) and Ferenc Jolez, MD (Brigham & Women’s)
 

Controlled cavitation – For several applications, including blood-brain barrier opening and brain tumor ablation, bioeffects arising from cavitation become important. Hence, ways of robustly and safely detecting, characterizing and controlling cavitation will be investigated.

Leader: JF Aubry , PhD (Institut Langevin); Working Group: Thilo Hoelscher, MD (UCSD), Arne Voie, PhD (UCSD), Beat Werner, PhD (University Children’s Hospital, Zurich) plus representatives from InSightec and Brigham & Women’s Hospital
 

Acoustic Radiation Force Imaging (ARFI) – This technique will allow the position of the acoustic focus to be identified with very low energy and negligible heating. ARFI will be important for functional procedures, drug delivery, non-thermal ablation and clot lysis applications. It also looks to be a primary tool in the development of MR-based focusing schemes which promise to make pre-procedure CT unnecessary.

Leader:Mickael Tanter, PhD (Institut Langevin); Working Group: Kim Butts Pauley, PhD (Stanford), Nathan McDannold, PhD (Brigham & Women’s), Beat Werner, PhD (University Children’s Hospital, Zurich)
 

Volumetric thermometry –It is critically important to provide real-time, intraoperative thermal feedback during focused ultrasound procedures in the brain. This provides necessary safety monitoring and also verification of the targeted area. Currently, only a single plane through the target is monitored. This group is investigating ways of providing real-time thermal monitoring in three dimensions in order to allow better target verification and more comprehensive safety monitoring in and around the brain.

Leader: Dennis Parker, PhD (Utah); Working Group: Nathan McDannold, PhD (Brigham & Women’s) and Kim Butts Pauley, PhD (Stanford)
 

The next Brain Program update will occur next October during the foundation’s 2012 International Symposium on Focused Ultrasound Therapy. The next invitational Brain Workshop is tentatively scheduled for 2013.

Written by Ellen C., McKenna

Related information:

Brain Program overview
FUSF sponsors Landmark MRgFUS Brain Workshop (April 2009)
Brain Workshop Summary (July 2009)
FUS Foundation’s Brain Program is off to a strong start (May 2010)

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