Focused ultrasound research will enter new territory in October when University of Virginia neurosurgeon W. Jeffrey Elias, MD performs the first investigational treatments on patients with tremor-dominant Parkinson’s disease. The study, which is being funded in part by the Focused Ultrasound Foundation, will enroll 30 patients and use a double-blinded protocol to randomly assign them to either treatment or control (sham treatment) groups. Designed to evaluate focused ultrasound’s safety and preliminary efficacy in treating tremor-dominant Parkinson’s disease, the study will follow patients’ progress for one year.
Initially, 20 of the 30 study patients will be assigned to the treatment group. The remaining 10 patients will receive a sham treatment. Three months later, the 10 will be eligible to cross over into the treatment group and receive focused ultrasound therapy.
Like the recently completed pilot study of 15 patients with medication-refractory essential tremor, the Parkinson’s trial will use InSightec’s ExAblate Neuro system and target a precise spot on the thalamus, a region deep within the brain associated with movement disorders. The unilateral thalamotomy procedures will be noninvasive – no scalp incisions or burr holes will be made and no electrodes will be placed in the brain. General anesthesia will not be used, and patients will remain awake and communicative throughout treatment.
“This study is the next step in the Foundation’s roadmap for developing a noninvasive treatment for certain patients with Parkinson’s disease,” says Focused Ultrasound Foundation Chairman Neal F. Kassell, MD. “The development pathway is defined and straightforward, and the technology is well-suited to improve patients’ quality of life in significant ways.”
The Parkinson’s study has been made possible by an innovative public/private partnership involving the Focused Ultrasound Foundation, the University of Virginia, the Commonwealth of Virginia and InSightec, Ltd. Foundation donors who have generously supported this initiative include David and Diane Heller, Robert and Molly Hardie and the Prince Charitable Trusts.
Patients who are interested in learning more about or volunteering for the study should send an email to FUSbrain@virginia.edu or call the University of Virginia clinical trials office at 434-243-1435.
Written by Ellen C., McKenna
Parkinson’s disease overview on Foundation website: here.