The first essential tremor patient in the pivotal trial for the ExAblate Neuro Focused Ultrasound System has been treated at Stanford, and the study is starting at the University of Virginia, Swedish Neuroscience Institute in Seattle, and Yonsei University Medical Center in Seoul, Korea.
The trial is a multicenter, double-blinded, randomized study to evaluate the efficacy and safety of treatment using the ExAblate Neuro in medication-refractory essential tremor patients. The study builds upon promising pilot studies funded by the Focused Ultrasound Foundation that demonstrated the preliminary safety and effectiveness of FUS in treating target areas deep inside the brain. These studies were published in the New England Journal of Medicine and The Lancet Neurology.
This important study is being funded through a unique public-philanthropy-industry collaboration between the FUSF, InSightec and The BIRD (US-Israel Binational Industry R&D) Foundation.
“We hope this pivotal trial will demonstrate safety and long-term efficacy, leading to the regulatory approval of focused ultrasound to help improve quality of life for people suffering from essential tremor,” said Foundation chairman Neal F. Kassell. “As we move forward, our goal is to continue to build innovative collaborations like our partnership with BIRD and InSightec to rapidly advance new treatments for patients with unmet medical needs.”
To learn more about the study, read the Press Release from InSightec. Read the DOTmed Daily News interview with Dr. Kassell about the study.
Information for Patients
Study sites are starting to recruit appropriate patients with essential tremor for this clinical trial. For patients who are interested in participating in the trial, sites can be contacted as follows. Due to the high volume of inquiries, there may be a delay in response to you:
University of Virginia—Charlottesville, VA
To submit yourself as a candidate, visit UVA’s online patient database at https://www.healthsystem.virginia.edu/focusedultrasoundtrial
Stanford University Medical Center—Stanford, CA
Email Ricardo Valenzuela at firstname.lastname@example.org
Swedish Medical Center—Seattle, WA
Contact Amanda Brown at (206) 320-3070
Yonsei University Medical Center—Seoul, Korea
Email Eun Jung Kweon at email@example.com
For additional information, please go to clinicaltrials.gov (NCT01827904) and US.insightec.com.