Posted on 08/26/2025 9:41:03 AM PDT by Red Badger
The first-ever neuroimmune modulation implant has been approved for people with moderate to severe rheumatoid arthritis (RA) who haven't found relief with traditional medications. It's a potentially life-changing technology that can zap pain by delivering one-minute electrical pulses to the vagus nerve – a key neural pathway that regulates inflammation.
The US Food and Drug Administration (FDA) has greenlit the device developed by California's SetPoint Medical, based on positive outcomes from the RESET‑RA clinical trial – a 242-patient, randomized, double-blind, sham-controlled study. It showed measurable improvements in disease activity by three months, with sustained benefits at 12 months. Impressively, 75% of participants were using just the implant and no other therapeutics after just 12 months.
We covered earlier trial stages of the device, which is about the size of a vitamin or coffee bean, back in 2021. However, the SetPoint System has been in development for two decades.
The tiny device takes the form of a miniature neurostimulator enclosed in a ceramic and titanium case. It is implanted in the left side of the neck via a minimally invasive outpatient procedure, under anesthetic.
It then delivers electrical stimulation to the vagus nerve once a day for up to a decade, activating the innate anti-inflammatory and immune-restorative pathways to block the dysfunctional signaling that causes the pain. Patients use a digital platform that tailors pulse dosage to their needs, and it can be recharged wirelessly once a week via a collar-like neckband.
(Excerpt) Read more at newatlas.com ...
Ping!.................
bkmk
bump to the top
Upon reading this, I was somewhat concerned about unintended side effects. Like , is there any affect on nerves other than the vagus nerve? My husband said that wasn’t going to be a problem. After all, what happens in vagus, stays in vagus.
A lot of people with rheumatoid arthritis really have hormone issues.
Ping
Lol. Good one! My daughter is researching vagus nerve stimulation
I should ask her about this. I wonder if it would affect arthritis that’s not rheumatoid.
Probably would not wok on osteoarthritis as the causes are different. It’s not inflammatory, but degenerative.
bookmark
.
Tell me more, please?
Can zap pain by delivering one-minute electrical pulses to the vagus nerve.
With my luck the laser will be the one they take down planes with.
<>sham-controlled study<>
Sham-controlled?
Educate me.
GOOGLE AI:
In medical research, sham-controlled refers to a type of clinical trial designed to test procedures or devices by comparing the active treatment against a “sham” or fake procedure. This is similar to a placebo-controlled trial, but is used when a physical intervention, rather than a pill, is being tested.
The goal of a sham-controlled trial is to isolate the specific effects of the treatment by creating a control group that experiences the same sensory and psychological aspects of the procedure, but without the key therapeutic component.
How sham-controlled trials work
Trial groups: Participants are typically divided into two groups through a randomization process:
Treatment group: Receives the genuine medical device or procedure being studied.
Sham-control group: Undergoes a fake version of the procedure that looks and feels real, but has no actual therapeutic effect.
Blinding: To prevent bias, these studies are often “blinded,” meaning participants do not know whether they are receiving the real or sham procedure. Sometimes, the practitioners are also blinded, known as a double-blind study.
Controlling for the placebo effect: A sham-controlled design helps researchers distinguish between the true effects of the treatment and the placebo effect, where a patient’s belief in the treatment leads to a perceived improvement. By comparing outcomes between the two groups, researchers can determine if the treatment itself is actually effective.
Examples of sham-controlled trials
Sham acupuncture: Some participants receive real acupuncture, while the sham-control group has needles placed in non-therapeutic areas or uses blunted needles that do not penetrate the skin.
Sham surgery: In a trial for knee surgery to treat osteoarthritis, some patients received the standard surgery, while the control group received an incision but no repair was performed. Both groups received the same pre- and post-operative care.
Sham devices: Trials for medical devices, such as those used for pain management, may compare an active device against a sham device that appears identical but is not turned on or functioning.
Ethical considerations
Sham-controlled trials, particularly those involving invasive procedures, are often controversial due to ethical concerns about exposing the control group to the risks of a procedure without any potential benefit. For this reason, these trials require robust informed consent and are often reserved for conditions where there is no existing, proven treatment.
It also happens to be the bulk of your entire parasympathetic nervous system. What could possibly go wrong?
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.