Subjects of Phase I Study of Transcranial MR-guided Focused Ultrasound Thalamotomy See Reduced Tremor, Improved Quality of Life
NEW ORLEANS (April 29, 2013) — Research findings offered today during the 81st American Association ofNeurological Surgeons (AANS) Annual Scientific Meeting show that the use of transcranial MR-guided focused ultrasoundfor producing a thalamotomy can have significant positive effects on subjects suffering from essential tremor.
A preliminary clinical trial suggested that acoustic energy could be delivered precisely to generate a focal stereotacticablation deep within the brain. In an FDA-approved clinical trial, 15 patients with medication-refractory essential tremorunderwent transcranial MR-guided focused ultrasound thalamotomy targeting the Vim nucleus. Adverse events wererecorded throughout the study, with comprehensive neurologic assessments for sensation, gait, strength and balance. A 160-point validated rating scale of tremor was used to assess the procedure’s efficacy on the subjects, and a quality-of-life-inessential-tremor questionnaire was obtained at pre, three-months and twelve-months post treatment. In addition, MRassessments were made of the lesions at one day, one week, one month and three months.The results of this study, The OneYear Results of a Phase I Study of Transcranial MR Guided Focused Ultrasound Thalamotomy for the Treatment ofMedication Refractory Essential Tremor, will be presented by William Jeffrey Elias, MD, FAANS, from 2:31-2:39 p.m. onMonday, April 29. Co-authors are Diane Huss, PhD; Johanna Loomba, BS; Mohamad Khaled, MD, MS; Eyal Zadicario,MSc; Scott Sperling, PhD; Robert Frysinger, PhD; Binit Shah, MD; Madaline Harrison, MD; and Max Wintermark, MD.
Those results showed a 67 percent reduction in contralateral hand tremor at one year. This unilateral reduction of tremor inthe dominant hand resulted in substantial improvements in daily disabilities (83 percent) and quality of life as assessed byclinicians and the subjects. Adverse events from the therapy were minimal and consisted mostly of mild paresthesia of theface or hand, but it is important to note that this preliminary feasibility study was not powered to determine the true safetyand efficacy of the treatment. The researchers concluded that this initial investigation of transcranial MR-guided focusedultrasound thalamotomy seems feasible and safe enough to proceed with more comprehensive clinical trials. The study’spresenting author, William Jeffrey Elias, MD, FAANS, noted that the investigators “plan to follow these patients annuallyjust as we do in our clinic with other movement-disorder procedures. We also are planning a long-term follow-up for ournext multi-center and international clinical trial, which is scheduled to begin this summer.”
Dr. Elias added that “it is important to realize from these results and those of other tremor procedures that tremorsuppression in the dominant hand, even if it is 75 percent on a rating scale, translates to very significant improvement infunctional abilities. Our patients experienced almost no residual disabilities in day-to-day activities with this degree oftremor suppression.” He also noted that the researchers were “extremely surprised” by the amount of interest the tremorcommunity had in this clinical trial. “We have been contacted by more than 2,000 people with tremor, which I think reflectstheir desire for more treatment options than we currently offer.”
Disclosure: William Jeffrey Elias, MD, FAANS, disclosed that the Focused Ultrasound Surgery Foundation providedgrant/research support and an honorarium.
Media Representatives: The 2013 AANS Annual Meeting Press Kit includes releases on highlighted scientific research,AANS officer and award winners, National Neurosurgery Awareness Week, and other relevant information about thisyear’s program. Those releases also will be posted under the Media area on the 2013 AANS Annual Scientific Meetingwebsite (http://www.aans.org/Annual Meeting/2013/Main/Media.aspx). If you would have interest in a topic related toneurosurgery or would like to interview a neurosurgeon — either on-site or via telephone — during this year’s event,please contact John Iwanski, AANS Director of Member and Public Outreach, via the onsite press room at (504) 670-4910or e-mail him at .
About the 2013 AANS Annual Scientific Meeting: Attended by neurosurgeons, neurosurgical residents, medicalstudents, neuroscience nurses, clinical specialists, physician assistants, allied health professionals and other medicalprofessionals, the AANS Annual Scientific Meeting is the largest gathering of neurosurgeons in the nation, with anemphasis on the field’s la research and technological advances. A record-breaking 1,003 scientific abstracts werepresented for review at the 2013 AANS Annual Scientific Meeting, and the scientific presentations given at this year’sevent represent cutting-edge examples of the incredible developments taking place within the field of neurosurgery.Additional information about the AANS Annual Scientific Meeting and the Meeting Program can be found at http://www.aans.org/Annual Meeting/2013/Main/Home.aspx.
Founded in 1931 as the Harvey Cushing Society, the American Association of Neurological Surgeons (AANS) is ascientific and educational association with nearly 8,300 members worldwide. The AANS is dedicated to advancing thespecialty of neurological surgery in order to provide the highest quality of neurosurgical care to the public. All activemembers of the AANS are certified by the American Board of Neurological Surgery, the Royal College of Physiciansand Surgeons (Neurosurgery) of Canada or the Mexican Council of Neurological Surgery, AC. Neurological surgeryis the medical specialty concerned with the prevention, diagnosis, treatment and rehabilitation of disorders that affectthe entire nervous system including the spinal column, spinal cord, brain and peripheral nerves. For moreinformation, visit www.AANS.org.###