Vagus nerve stimulation device offers hope to rheumatoid arthritis sufferers as Manhasset center opens

One night about 15 years ago, Dawn Steiner, of Massapequa, climbed into bed looking for a good night’s sleep. When she woke up the next morning, Steiner felt as if she had been "run over by a truck."

"I couldn’t lift my arms," Steiner, a speech pathologist, recalled in an interview. "My husband had to help me wash my hair and brush my teeth."

Steiner, 58, was experiencing the first, painful symptoms of rheumatoid arthritis and spent the next decade or so seeing doctors and looking for relief. Medications only temporarily eased the swelling and stiffness in her body.

Two years ago, she had a small vitamin-sized device implanted between her neck and her shoulder that stimulates her vagus nerve — which runs from the brain to the stomach, controls breathing, heart rate and immune responses — once a day.

Within the first week she started feeling less stiff along with a reduction in her pain and swelling.

"No one is saying that this is the cure-all for everyone," said Dr. Kevin Tracey, CEO of the Feinstein Institutes for Medical Research and a neurosurgeon who has focused his research on inflammation, the mechanisms of how neurons control the immune system and stimulation of the vagus nerve. "The scientific, medical and clinical trial evidence indicates it's going to be a hugely important therapy for many people."

On Tuesday, Northwell Health is scheduled to announce it will open a Center for Bioelectronic Medicine in Manhasset, where the Feinstein Institutes has been exploring this technology.

Vagus nerve stimulation has been approved by the U.S. Food and Drug Administration to treat epilepsy and depression and health systems on Long Island have been using it for those conditions. The agency is expected to make a decision by the end of the year on whether to approve it for people with rheumatoid arthritis who have not had success with other medications and biologics.

More than 240 people were enrolled in the clinical study run by SetPoint Medical, which manufactures the implant Steiner uses. At 12 weeks, 35% of those people receiving treatment noted improvements. By 24 weeks, over 50% reported a reduction in symptoms and 81% of patients were not using steroids or any biologic treatments to manage their symptoms. The most common side effect reported was mild to moderate hoarseness. 

The device sends small electrical impulses to the vagus nerve for about one minute every day to activate the body’s natural immune response, according to SetPoint.

Tracey compared the vagus nerve to a "complex, transatlantic cable" in a person’s body, with 200,000 vagus nerve fibers.

He said by stimulating the vagus nerve branches to the spleen, it slows the body’s inflammatory overreaction by the immune system known as a cytokine storm.

"It's like the brakes on your car. ... Your brain has brakes in place to keep your heart from racing and to keep your immune system from spinning out of control," he said. "It’s the body's natural way of preventing the side effects of too much inflammation."

Tracey cofounded SetPoint Medical in 2007 based on his research discoveries and since then has become an adviser. He noted he is not involved in the clinical trial or the day-to-day operations of the company. Northwell was one of the surgical locations for the clinical trials across the United States.

"The exact price of the SetPoint System isn’t available yet," a company spokesperson said in a statement. "Overall, the one-time cost of the implantation procedure and device, which would deliver therapy for 10 years, is expected to be less than the cost of 1 year of RA drugs."

Steiner, who has two grown children, said the treatments have alleviated her stiffness and pain, allowing her to go back to doing many of the things she loved, like attending more New York Mets baseball games. While her pain rating was a 3 or 4 on a scale of 1 to 10 when her medications were working, it’s now a 1 on most days.

"There were times I would come home from work and get right into bed and all I did was lay on the couch all weekend," she said. "Now we're out, we're doing things, we're walking, we're going to concerts, we're going on vacation. We're living." 

By Lisa L. Colangelo

lisa.colangelo@newsday.com@lisalcolangelo

Lisa joined Newsday as a staff writer in 2019. She previously worked at amNewYork, the New York Daily News and the Asbury Park Press covering politics, government and general assignment.