The MED Institute performs virtual testing and validation of medical devices


Robroek is also a remote area. Koopman led a landmark 17-person trial that tested whether modifying the patterns of electrical signals in the nervous system could reduce inflammation and joint pain in rheumatoid arthritis. Robroek was one of the few who achieved a significant and sustainable reduction in the severity of the disease, according to
2016 paper.

Illustrated image of a woman showing a branching nerve in her neck and a blue rectangle next to it.

The SetPoint implant is inserted next to the patient’s vagus nerve, which travels from the brain to the nerves to the spleen and other vital organs.Chris Philpott

Experimental studies like Koopman’s are one thing, but scientific certainty requires faulty randomized trials. Clinicians, neuroscientists and bioengineers should soon get a better idea of ​​how electrophysiological devices perform. In late 2023,
SetPoint MedicalValencia, Calif., the company that sponsored Koopman’s initial experiment, will report preliminary results from the study Reset-RAIt is the first large-scale nerve stimulation screening for an autoimmune condition. Like the previous experiment, the study targets Reset-RA vagus nervethe main channel of communication between the brain and the body, in an effort to fight inflammation.

Expectations are charged. Although devices that harness electrical impulses are already widespread in medicine, these platforms all take advantage of neural circuits that directly affect diseased tissue; For example,
Deep brain stimulators It helps treat symptoms of Parkinson’s disease by penetrating the motor control center of the brain. Nobody is targeting what Kevin Tracypoignantly 2002 articlecalled the “inflammatory reflex,” is a neural network that indirectly regulates immune responses to infection and injury through the vagus nerve and its related organs.

Tracy, a former neurosurgeon who drives
Feinstein Institutes for Medical Research In Manhasset, New York, he was the first to show that stimulation of the vagus nerve in rats can occur release suppression of immune signaling molecules. is later link effect to vagus nerve signals reaching the spleen, a fist-sized organ in the abdomen where immune cells are activated. In 2007, Tracy co-founded SetPoint to bring therapy to the clinic.

The company first repurposed an off-the-shelf implant to control seizures in people with epilepsy. SetPoint refined stimulation parameters, using rodent studies for guidance, before giving the devices to patients like Robroek. Both she and the other recipients had a cookie-sized pulse generator surgically inserted inside their chests. A wire is looped up to the left side of the neck, where an electrode wraps around the vagus nerve. She gave a gentle buzz for one minute of stimulation up to four times each day.

The study targets the vagus nerve, the main channel of communication between the brain and the body, in an effort to combat inflammation.

Paul Peter Tack, the immunologist and biotech entrepreneur who led the trial with Koopman, was concerned that patients with rheumatoid arthritis might not want to undergo surgery and have devices implanted under their skin. But after the study was published on Dutch TV, Tack was inundated with requests from patients weary of endless regimens of pills and injections. “This was my unplanned market research,” says Tuck. “To my surprise, there are many patients who may prefer a one-off surgery.”

While the results of the study were promising, the device itself was cumbersome. So SetPoint overhauled the platform, shrinking it down to a peanut-sized nerve stimulator with built-in electrodes and a wirelessly rechargeable battery, all encased inside a silicone pod that sits directly over the vagus nerve in the neck. “It’s like going from an old car to a Tesla – completely redesigned,” says SetPoint’s chief medical officer.
David Chernoff.

A small experiment was conducted in 2018
prover That this miniature device was safe. The 250-person Reset-RA study, in which half of the participants received no stimulation during the first 12 weeks after transplantation, is now evaluating effectiveness. If successful, trials for other autoimmune diseases could follow.

Silver and white capsule-shaped body on a blue background.  Writing on the white part.SetPoint has shrunk the vagus nerve stimulator so that it can be implanted in a patient’s neck instead of the chest.SetPoint Medical

Meanwhile, other companies are testing devices that target nerves closer to the site of immune activation — “at the business end,” he says.
Christopher PhamThe head of the British company Galvani Bioelectronics. Pham argues that this end-organ approach to neuronal agitation should allow for more subtle, disease-specific neuromodulation, without the off-target effects of vagus nerve trauma, which is central to many bodily processes.

A joint venture between Google’s parent company,
the alphabetand a British pharmaceutical company GSKGalvani now evaluation An implantable splenic nerve stimulator in small numbers of rheumatoid arthritis patients. Another company called SecondWave Systems, based in Minneapolis, is also testing whether ultrasound guided from the spleen can deliver the same immunosuppressive effects without the burden of invasive surgery. Galvani and SecondWave expect to announce the first data of their kind in humans within the next year.

“Neuromodulation is definitely having a moment,” he says.
Gene Civilicoa neurotechnologist at Northeastern University in Boston, who previously supervised Research efforts in bioelectronics In the US National Institutes of Health. “Controlling neural tissue in a spatially and temporally precise way is going to be the way we treat or modify many disease states,” says Civilico. Next year, SetPoint and other companies hope to prove it right.

This article appeared in the January 2023 print issue under the headline, “Arthritis takes a jolt.”

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