Key Points
- An international clinical trial is investigating the use of focused ultrasound on an alternative target in the brain to treat the motor symptoms of Parkinson’s disease.
- In the bilateral trial, participants will be evaluated for treatment on the other side of the brain six months after initial treatment.
- Sites in Maryland, New York, California, and Taiwan are now seeking patients.
An international clinical trial is investigating the safety and efficacy of MR-guided focused ultrasound to treat the motor symptoms of Parkinson’s disease (PD). This is a bilateral trial, meaning that participants will receive focused ultrasound on one side of their brain, and, after a period of six months, patients will be evaluated for treatment on the other side. Five sites in the US and Taiwan are currently enrolling patients.
In December 2018, focused ultrasound earned FDA approval to treat the symptoms of tremor-dominant PD (TDPD), and that approval was expanded to a wider range of PD symptoms earlier this month. These approved therapies require physicians to target specific locations in the brain – the ventral intermediate (VIM) nucleus for TDPD and the globus pallidus internus (GPi) for patients with mobility, rigidity, or dyskinesia symptoms. However, in this new bilateral study, researchers are targeting an alternate location – a system of nerve fibers in the middle of the brain called the pallidothalamic tract (PTT).
“There has been clinical work in Switzerland and Japan investigating the PTT target to control the motor symptoms of PD,” says the trial’s principal investigator, Howard Eisenberg, MD, R.K. Thompson Professor, Department of Neurosurgery at the University of Maryland. “Compared to the others, the PTT is a small target, but the results that have been published from other sites are positive. This clinical trial aims to support those earlier studies and provide additional data to identify the best target for these patients.”
The trial is expected to enroll 50 patients at up to eight sites in the US and Taiwan. Each participant will undergo a single focused ultrasound treatment and be evaluated regularly over the next six months. At that time, patients will be offered a second focused ultrasound procedure on the other side of their brain if deemed eligible.
“For focused ultrasound to become a mainstream therapy for Parkinson’s patients, it will have to be a bilateral treatment,” explains Dr. Eisenberg. “We are actively working toward that goal and determining the best target in the brain. Treating it with minimal risk and good results is critical.”
It is important to note that focused ultrasound does not currently address the underlying cause of PD. This trial is investigating relief from its debilitating symptoms.
For Patients
This clinical trial is currently enrolling at four sites in the US and one in Taiwan. We encourage you to read more about the study and contact the site nearest you for more information.
University of Maryland
Baltimore, Maryland, USA
Contact: Kaitlyn Henry (410-328-0939, khenry@som.umaryland.edu)
Stanford University
Palo Alto, California, USA
Contact: Bharati Sanjanwala (650-721-2830, bharatis@stanford.edu)
New York University Langone
New York, New York, USA
Contact: Cathryn Lapierre (Cathryn.lapierre@nyulangone.org)
Weill Cornell Medicine
New York, New York, USA
Contact: Rachael Olovyannikov (212-746-7373, rao4005@med.cornell.edu)
Contact: Blagovest Nikolov (212-746-9882, Bln2001@med.cornell.edu)
Chang Bing Show Chwan Memorial Hospital
Lugang, Changhua County, Taiwan
Contact: Wei Chieh Chang, MD (changweichieh@gmail.com)
Contact: Yen-Hui Yang (+886-4-7813888 ext 70379, irene.yang71917@gmail.com)