People suffering from rheumatoid arthritis have few choices for treatments – mainly drugs with potential side effects – but a new device being tested might alleviate symptoms without medication.
The Reset-RA trial is seeking 250 participants to study the effectiveness of a surgically implanted, miniaturized stimulator to deliver targeted electrical pulses to the vagus nerve. Stimulating neural pathways that control systemic inflammatory pathways offers another potential way of treating RA patients who have inadequate responses or are intolerant to medications, a news release stated.
Arthritis Northwest in Spokane is one of 40 sites for the study. Dr. Howard Kenney is the lead for enrolling qualified participants in the randomized, double-blind study on the bioelectronic vagus nerve stimulation.
“This is an investigational device; there have not been studies done on this scale until now,” Kenney said. “The hope is it will at least be equivalent to pharmaceuticals, and it will give us another instrument to use since we do have a limited number of therapeutic interventions. Hopefully, it will be even better.”
Patients who meet the trial’s criteria will have SetPoint Medical’s miniaturized stimulator surgically implanted with a single incision in the crease of the neck. A neurosurgeon will place it on the left side of the neck onto the vagus nerve in a surgery that takes about an hour under general anesthesia.
Patients typically go home the same day. The device is designed to deliver targeted electrical pulses to the vagus nerve to trigger an innate neurological pathway that reduces symptoms without requiring immunosuppression.
For a double-blind study, the devices randomly will be turned on in some patients but not in other participants. Groups will be evaluated for three months, and after that time, all of the participants will have the option to have their devices turned to an active stimulation for a follow-up study of more than three years. Doctors will monitor any progress by tracking joint pain differences and using assessment tools.
To be eligible, people enrolled must be ages 22 to 75 with active moderate or severe rheumatoid arthritis, have a demonstrated inadequate response or intolerance to one or more of the approved drugs for the disease, and be receiving treatment with at least one conventional synthetic disease-modifying anti-rhueumatic drug for at least 12 weeks, along with other treatment criteria.
Rheumatoid arthritis is an autoimmune and inflammatory disease, which means that the immune system attacks healthy cells in the body by mistake, causing painful inflammation that mainly attacks the joints. RA commonly affects joints in the hands, wrists and knees. About 1.5 million people in the U.S. have rheumatoid arthritis, according to the Arthritis Foundation.
Kenney has treated rheumatoid arthritis patients for 30 years. He said doctors in the past 10 to 15 years have had a few more therapies to offer, including bioengineered medications sometimes called biologics.
One approach is use of Janus kinase inhibitor medications to block proteins that trigger the inflammation process. However, 30%-40% of patients either don’t adequately respond to various rheumatoid arthritis medications or have an intolerance to the drugs.
Some of these drugs require injections that can run the risk of infections. Patients also might get injection-site irritation, swelling and sometimes problems such as stomach issues, skin rashes and headaches, Kenney said. “They almost all have potential for side effects,” Kenney said. “Infection is always a big one that worries us.”
Kenney said more women than men get the disease, and for reasons not understood, the Northwest seems to have a higher percentage of patients. He’s looking forward to testing a device that might help.
“It’s a bioelectronic medical investigational device, so that bioelectronic part of it brings in the biology of the immune system, as well as the electronic part of it through the vagus nerve,” Kenney said. “It’s brand new technology and can make some real headway in areas that have not been explored thus far.”
The device has a capsule around it so it’s protected, and the body’s environment is protected from it, he said. “Some of these kinds of devices have been used for years for other kinds of things like epilepsy, for example, and even Parkinson’s disease, so there’s been some similar kinds of neural stimulation.”
The trial’s enrollment has started, and the Spokane site has at least two patients being screened. Spokane participants don’t have to be patients of Arthritis Northwest, but if selected, they would go in for study evaluations at the site, located in the Sacred Heart Doctors Building, 105 W. Eighth Ave.
People with rheumatoid arthritis interested in finding out if they qualify can call Terri Cone at Arthritis Northwest at (509) 838-6500, ext. 310, or email her at firstname.lastname@example.org. Other information on the study is available at RESET-RA.study.
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