WASHINGTON, DC (October 3, 2011) - In a presentation at the Congress of Neurological Surgeons today, University of Virginia neurosurgeon W. Jeffrey Elias, MD reported that preliminary results of a pilot clinical trial indicate that MR-guided focused ultrasound has the potential to safely and effectively control essential tremor (ET), a common neurological condition that affects 10 million Americans.
Results from the study's first 10 patients showed a 78 percent improvement in contralateral tremor scores in the hand, as assessed with the Clinical Rating Scale for Tremor (CRST).
Patients' functional activities scores improved by 92 percent, as measured in the 'Disability' subsection of the CRST. Outcomes and complications were comparable to other procedures for tremor, including stereotactic thalamotomy and deep brain stimulation.
"So far, this noninvasive treatment has been life-changing for patients," said Elias, the study's principal investigator and Director of Stereotactic and Functional Neurosurgery at UVA.
Most study participants have had ET for decades, Elias
As part of the study's inclusion criteria, all had previously taken at least two medications that failed to control their tremor.
Despite the severity of their disability, patients had opted to cope with symptoms rather than undergo invasive surgical procedures.
Conducted under an FDA-approved protocol, the single-arm, non-randomized, phase 1 study began in February 2011 and is expected to treat 15 patients before concluding.
All patients are being followed for three months.
If final results prove successful, Elias
anticipates launching a larger, pivotal trial to study the overall safety and long-term efficacy of MR-guided focused ultrasound in treating medication-refractory ET.