The findings of a serious international trial to check a high-tech, scalpel-free approach to treating movement problems attributable to Parkinson’s disease have been published in the distinguished Recent England Journal of Medicine.

Jeff Elias, MD, pioneered the usage of focused ultrasound for the treatment of essential tremor and Parkinson’s disease. Image Credit: UVA Health

 UVA neurosurgeon Jeff Elias, MD, and collaborators examined the advantages and risks of using focused ultrasound to focus on an area deep inside the brain called the globus pallidus. The researchers desired to see if the focused sound waves could improve trial participants’ ability to maneuver and reduce the unwanted shaking and rigidity related to Parkinson’s.

Of the 69 patients who received the procedure within the randomized trial, almost 70% responded to the treatment. Thirty-nine participants who received the procedure continued to see significant advantages three months later, and 30 of those assessed on the one-year mark continued to see advantages. The procedure, the researchers conclude, might be particularly useful for patients who’re ineligible or unwilling to receive deep brain stimulation, a surgery that implants electrodes deep within the brain to perform the identical symptom-management goals.

The focused-ultrasound trial results were shared with the federal Food and Drug Administration prior to publication and were a crucial consideration within the agency’s decision to expand approval of the technology for the treatment of Parkinson’s disease in 2021.

This study is promising for patients with Parkinson’s disease and other neurological conditions. Ultrasound was precisely focused deep contained in the brain to change certainly one of the abnormal circuits of Parkinson’s disease. But it will be significant to grasp that the treatment improved the neurological symptoms of PD and didn’t alter its course. Ultimately, we hope to someday cure PD.”

Jeff Elias, MD, UVA Neurosurgeon

About focused ultrasound

The focused ultrasound procedure focuses sound waves contained in the brain to disrupt faulty brain circuits, like how a magnifying glass can focus light. Unlike deep brain stimulation, the minimally invasive procedure doesn’t require incisions or opening the skull. The procedure is guided by magnetic resonance imaging (MRI), so doctors can pinpoint the precise right spot within the brain before making any everlasting changes.

Participants within the randomized Parkinson’s trial were assigned to receive either the focused-ultrasound treatment or a harmless pretend – or “sham” – procedure. In total, 69 received the actual treatment and 25 received the sham procedure. The participants’ symptoms were then assessed using two common rating scales, one for patients on medication and one for patients off medication.

Sixty-nine percent of the procedure recipients improved by at the very least three points on one or each of the rating scales. That’s compared with only 32% (seven participants) within the control group. Within the control group, significant improvements were seen only in patients on medication.

Negative effects reported by treatment recipients included trouble speaking, difficulty walking and lack of taste. The lack of taste and difficulty walking were mild and resolved on their very own. One participant continued to experience slurred speech a yr after the procedure, the researchers report.

Elias’ pioneering research into the usage of focused ultrasound for Parkinson’s is just the most recent in his greater than decade-long effort to tap the vast potential of the technology. His prior work prompted the federal Food and Drug Administration to approve focused ultrasound for the treatment of essential tremor, a standard movement disorder, in 2018. That approval represented a turning point for the technology and helped spur additional research at UVA and elsewhere.

Elias and his UVA Health colleagues proceed to explore the various possible applications of focused ultrasound. For instance, UVA Health last yr joined with the Charlottesville-based Focused Ultrasound Foundation – a longtime supporter of UVA’s focused ultrasound research – to launch the world’s first center devoted specifically to combining focused ultrasound with immunotherapy to reinforce the body’s ability to battle cancer. Other potential applications include using the technology to open the brain’s natural protective barrier to permit, for the primary time, the targeted delivery of medication for neurological diseases comparable to Alzheimer’s.

UVA’s transformative work with focused ultrasound was recently highlighted around the globe by CNN’s Sanjay Gupta in a story that showcased a procedure conducted by Elias and his team.

In regards to the research

The Parkinson’s research team consisted of Vibhor Krishna, Paul S. Fishman, Howard M. Eisenberg, Michael Kaplitt, Gordon Baltuch, Jin Woo Chang, Wei‑Chieh Chang, Raul Martinez Fernandez, Marta del Alamo, Casey H. Halpern, Pejman Ghanouni, Roberto Eleopra, Rees Cosgrove, Jorge Guridi, Ryder Gwinn, Pravin Khemani, Andres M. Lozano, Nathan McDannold, Alfonso Fasano, Marius Constantinescu, Ilana Schlesinger, Arif Dalvi and Elias. Elias is a consultant for Insightec, the manufacturer of the focused ultrasound technology; a full list of the authors’ disclosures is included within the paper.

Financial support for the Parkinson’s trial was provided by Insightec.

Source:

Journal reference:

Krishna, V., et al. (2023). Trial of Globus Pallidus Focused Ultrasound Ablation in Parkinson’s Disease. Recent England Journal of Medicine. doi.org/10.1056/nejmoa2202721.