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Sunnybrook Research Institute scientists Dr. Lipsman, left, and Dr. Hynynen, with the groundbreaking helmet-like device that delivers extraordinarily precise focused ultrasound therapy deep within the brain without an MRI machine.Jennifer Roberts

Using sound waves to treat hard-to-cure conditions like brain cancer and Alzheimer’s may sound like science fiction, but the technology has been quietly advancing for decades.

Now, thanks to groundbreaking new technology developed by scientists at Sunnybrook Research Institute in Toronto, this treatment may soon become more accessible than ever.

Nearly a decade after the same Sunnybrook scientists achieved a world first by using MRI-guided focused ultrasound to open the blood-brain barrier (BBB) to deliver chemotherapy directly to a patient’s brain tumour, they are on the verge of another leap forward.

Their new customizable device, resembling a futuristic bicycle helmet with an intricate array of thousands of sound wave emitters, delivers extraordinarily precise focused ultrasound therapy deep within the brain without an MRI machine.

Though still in the early phases of safety and efficacy experiments, this feat is a game-changer that dramatically cuts costs and time while expanding the technology’s reach.

“I don’t claim to be a physicist; I’m just a lowly neurosurgeon. But what we’re talking about here is a revolutionary change – a quantum leap forward in technology,” says senior scientist Nir Lipsman, MD, PhD, chief of the Hurvitz Brain Sciences Program at Sunnybrook and one of the leading researchers at Sunnybrook’s Harquail Centre for Neuromodulation.

Focused ultrasound, a non-invasive therapeutic technology first explored in the 1940s, has opened new possibilities for treating complex brain conditions through three main techniques: ablation, BBB opening and neuromodulation – offering hope where conventional therapies often fall short.

Ablation, already widely used to treat essential tremour disorder, uses targeted acoustic energy to destroy diseased tissue without harming healthy cells – a safer, non-invasive alternative to surgery. BBB opening provides pathways to otherwise inaccessible areas for a number of treatments, among them chemotherapy drugs for brain tumours and antibodies for Alzheimer’s.

Meanwhile, neuromodulation can gently stimulate or calm specific brain regions, holding promise for conditions such as Parkinson’s, severe depression, addiction and other brain disorders.

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This ‘next-generation’ helmet is the culmination of decades of research into ultrasound therapies.Jennifer Roberts

“The idea of using the same waves that let you hear my voice right now to influence the brain – it’s hard to wrap one’s head around how significant that really is,” says Dr. Lipsman.

Over the past decade, the numbers also tell a story of remarkable growth in the field of focused ultrasound – opening new possibilities for impact on global health care. Ten years ago, according to the Focused Ultrasound Foundation (FUSF), there were only three clinical disorders or diseases in various stages of research, development and commercialization for focused ultrasound treatments.

Today, that number has soared: more than 170 medical conditions are being investigated. Similarly, the number of manufacturers producing focused ultrasound devices has increased from five to 79, reflecting the rapid expansion and investment in this technology.

Patient access has also expanded rapidly, growing from 100,000 treatments in 2022 to nearly 150,000 in 2023. The FUSF predicts that by 2030, over one million patients will be treated annually at 10,000 global treatment sites.

For Kullervo Hynynen, the pioneering physicist behind the helmet, this device is the culmination of more than 30 years of work to bring these therapies to life. “It is very rewarding,” says Dr. Hynynen, Sunnybrook’s vice-president of research and innovation. “I don’t see any reason why this wouldn’t become a routine clinical treatment.”

Other experts share his optimism about the technology’s advancement.

“It’s like the evolution from the Model T Ford to an EV Ferrari, right?” says Neal Kassell – founder and chairman of the FUSF and former co-chair of neurosurgery at the University of Virginia – highlighting the significant technological leap represented by Sunnybrook’s “next-generation” helmet.

Removing the need for MRI machines, he notes, was crucial for making this technology more accessible. Sunnybrook’s helmet, he adds, is by far the most advanced device of its kind.

“It’s the obvious next step in democratizing this technology to treat a wide variety of diseases,” Dr. Kassell says.

While the helmet technology is ready for clinical trials on humans, it has so far been tested only on animals during pre-clinical research. The Sunnybrook team, which conducts more clinical trials on focused ultrasound than anywhere else in the world, is waiting for Health Canada approval to begin multiple trials on humans in 2025.

If successful, Dr. Hynynen and Dr. Lipsman estimate it could be another three to five years before the technology becomes available in medical practice.

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