CompletedNot Applicable

Effects of Chronic Non-invasive Vagus Nerve Stimulation in an Asplenic Individual Suffering From Rheumatoid Arthritis

Canada1 participantsStarted 2020-01-30

Plain-language summary

The goal of this clinical trial is to learn if chronic self-administrated non-invasive vagus nerve stimulation works to improves the disease activity in a single asplenic patient suffering from rheumatoid arthritis. It will also learn about the safety of at-home chronic non-invasive vagus nerve stimulation. The main questions it aims to answer are: Does chronic non-invasive vagus nerve stimulation improves the disease activity? Does chronic non-invasive vagus nerve stimulation decrease CRP serum level? Does chronic non-invasive vagus nerve stimulation improve HRV and the sympathy-vagal balance? Participant will: Stimulate at home the left auricular branch of the vagus nerve for 24 months with three different protocol of stimulation (parameters and duration) Visit the clinic once every 2 months for checkups and tests Will have blood work for CRP level check every 8 months

Who can participate

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * diagnosed RA * splenectomy Exclusion Criteria: Pharmaceutical treatment as: * disease-modifying antirheumatic drugs (DMARDs) * Biologics * Jak inhibitors

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial tested non-invasive vagus nerve stimulation in someone without a spleen — since I still have my spleen, does that mean the findings might not apply to my situation, and is that worth discussing?
2The trial is already completed and was listed as 'Phase NA,' which suggests it may have been a very early or exploratory study — what does that mean for how much we can trust the results when thinking about my treatment options?
3The main thing they measured was the Simple Disease Activity Index, or SDAI — based on whatever results were reported, did the stimulation actually move the needle on disease activity in a meaningful way compared to what standard RA treatments can do for me?
4Since this was apparently a study involving a single individual with a very specific health profile, how much weight should we put on its findings when deciding whether vagus nerve stimulation is worth pursuing in my case?
5Are there any ongoing or larger trials on non-invasive vagus nerve stimulation for rheumatoid arthritis that might be a better fit for my situation, given how limited the scope of this completed study seems to be?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the Simple Disease Activity Index (SDAI) for Rheumatoid Arthritis

Timeframe: From enrollment to the end of treatment at 24 months

Trial details

NCT IDNCT07646470

SponsorOsteoflow Health Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-04

View on ClinicalTrials.gov More Rheumatoid Arthritis (RA trials