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Long Island researchers’ clinical trial targets lupus pain

Dr. Kevin Tracey of The Feinstein Institute for

Dr. Kevin Tracey of The Feinstein Institute for Medical Research in Manhasset, shown in his lab on July 7, 2016, holds a device that delivers neurostimulatory impulses and can be used to treat rheumatoid arthritis. This year his team will conduct a clinical trial to research whether the approach alleviates the pain caused by lupus. Credit: Chris Ware

A team of Long Island doctors is embarking on a clinical trial this year that will ask a compelling question: Can a tiny bioelectronic implant banish pain caused by lupus, a debilitating, inflammatory disorder that largely affects women?

Dr. Cynthia Aranow, a medical investigator at the Feinstein Institute for Medical Research, disclosed the upcoming trial during a recent roundtable discussion at the Manhasset facility.

Using an implanted device, “we will be stimulating lupus patients who have musculoskeletal pain,” said Aranow, who works in the institute’s Center for Autoimmune and Musculoskeletal Disorders. The implant will be connected to a key nerve that runs through the neck — the vagus — and will deliver minuscule doses of electricity at programmed intervals.

Doctors have not decided on the trial’s start date. But they are certain that when it comes to treatment of complex inflammatory disorders, it is time to rethink the need for drugs.

The lupus-focused research is the latest test based on groundbreaking discoveries by Dr. Kevin Tracey, the institute’s president and pioneer of a paradigm-shifting field of treatment: bioelectronic medicine.

Tracey posits that treatment with minute pulses of electricity can control pain and eliminate the need for pharmaceuticals. An investigation of patients with rheumatoid arthritis has confirmed his theory.

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Gov. Andrew M. Cuomo’s administration is so convinced that Tracey and his Feinstein team are on a breakthrough track that it pledged $50 million to the institute last year to support bioelectronic research.

“After 18 years, the time for this idea has finally arrived,” Tracey said in a recent interview.

General Electric, which has a medical electronics division, is in talks with him and his Feinstein colleagues on potential projects, Tracey confirmed, as are several other corporations whose names he would not disclose.

Pharmaceutical giant GlaxoSmithKline in August 2013 announced its investment in SetPoint Medical, a California company co-founded by Tracey that develops implantable neurostimulating devices. Tracey also has lured bright minds in science and engineering to Feinstein, including Chad Bouton, who was on the Ohio team that created a brain implant enabling a paralyzed man to use his thoughts to move his fingers and play a guitar.

The lupus trial marks the first U.S. clinical investigation of bioelectronic medicine for an inflammatory disease.

Lupus, formally known as systemic lupus erythematosus, is an incurable autoimmune condition caused when a patient’s immune system becomes a turncoat, launching an inflammatory attack. A characteristic “butterfly rash” often develops on patients’ faces. Excruciating muscle and joint pain are a hallmark of the disorder, as are attacks on internal organs and blood vessels. Some patients require a kidney transplant.

Women develop lupus at a 9-to-1 ratio compared with men and usually are diagnosed between the ages of 15 and 45, although the disorder can occur in childhood or late in life. Lupus afflicts about 1.5 million people nationwide.

“It affects a population at a very productive time in their lives,” Aranow said, referring to the majority of patients. However, she said, “I’ve seen it in babies and I have diagnosed it in an 82-year-old.”

For reasons not understood, African-Americans, Latinos and Asians are more likely to be affected by lupus than Caucasians, but the condition is widely diagnosed worldwide in all people and in both women and men.

The upcoming trial will address only patients’ muscle and bone pain, Aranow said.

Using electrical impulses to treat medical conditions is not a new idea. Implanted neurostimulators are prescribed for some forms of epilepsy. Cardiac pacemakers rely on electrical pulses to prompt the heart to beat at a normal rate, and for decades far less sophisticated devices have been implanted to treat various forms of chronic pain.

What is new in the Feinstein Institute’s approach is researchers’ use of electrical impulses to tackle the underlying causes of inflammation.

Researchers at one of the Netherlands’ leading hospitals who relied on Tracey’s theories reported last year that they were able to control rheumatoid arthritis using bioelectronic medicine.

A group of 18 patients at the Academic Medical Center, which is affiliated with the University of Amsterdam, completed a clinical study in which they received a small implant connected to the vagus nerve — which begins in the brain stem and passes through the neck and thorax to the abdomen. The device delivered a daily dose of electricity that lasted 1 to 5 minutes, and a dramatic decline in symptoms resulted.

Rheumatoid arthritis, like lupus, is considered an inflammatory disease because it is driven by the immune system’s most potent forces — bombardments of infinitesimal hormone-like proteins called cytokines, especially one known as TNF, or tumor necrosis factor.

Cytokines attack joints throughout the body, causing pain and disfigurement. About 1.3 million people in the United States — most of them women — are affected.

A patient in the Dutch trial, who requested anonymity, told Newsday in an email that the neurostimulation could not be felt and the arthritic pain was alleviated. The trial was led by Dr. Paul-Peter Tak and drew inspiration from Tracey’s earlier research.

Tracey, a neurosurgeon, scientist and inventor, first advanced what seemed a radical hypothesis in the late 1990s: He postulated that the vagus nerve is intimately involved in the function of the immune system.

Doctors at the time scoffed. Few believed Tracey because, if his theory was true, that would mean the brain controlled the vast and seemingly amorphous immune system.

Tracey stunned the medical world when he completed a series of animal studies demonstrating that the vagus nerve, which becomes a network with 80,000 branches, plays a key role in the immune response. Because of his research, medical textbooks have been rewritten.

The vagus interfaces with major organs, including the spleen, a veritable storehouse of immune system cells and proteins — the very forces that go awry in inflammatory, autoimmune diseases.

Tracey defined what he calls the inflammatory reflex, a neural circuit involved in the immune response. That finding paved the way for a bioelectronic strategy in inflammatory diseases. The treatment, Tracey and other experts say, is a method of helping the body heal itself.

“We are trying to get a reflex to be triggered and allow the body to do the rest of the work. That’s the beauty of it,” said Anthony Arnold, chief executive of SetPoint Medical, which made the bioelectronic implants used in the Dutch clinical trial. Work is underway on a smaller, pill-sized implant, Arnold said.

Overall, bioelectronic medicine is more cost-effective and lacks the side effects common with pharmaceuticals, he said.

“This should lead to much safer therapy for patients in the long run,” Arnold said.

Once a bioelectronic device is implanted, patients won’t need a new one for at least a decade, he added, and for those with rheumatoid arthritis that means dramatically lower costs. Currently, biologic drug therapy for the condition runs more than $30,000 a year.

Arnold sees bioelectronics becoming a major therapeutic division, standing alongside pharmaceuticals and medical devices.

Aside from lupus and rheumatoid arthritis, Tracey and his colleagues said bioelectronic medicine can be an effective treatment for sepsis, hemorrhagic shock, some forms of cancer and Crohn’s disease.

Four clinical trials focusing on the bioelectronic treatment of Crohn’s — an inflammatory disease marked by severe abdominal pain and diarrhea — are being conducted in Europe.

In November, Tracey announced the development of a small, clothespin-like device, called a neural tourniquet, that stops postpartum hemorrhaging when clipped to a patient’s ear. The device uses electrical nerve stimulation to reduce blood loss.

Tracey, meanwhile, sees the Dutch trial as confirmation that his original hypothesis 18 years ago was correct.

“It is very gratifying to work on a basic scientific discovery that has a certain satisfaction all of its own — the basic gratification that comes when you see a patient benefiting,” he said.

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