What To Expect During The Study for Vagus Nerve Stimulation for RA
If you take the qualification survey on our website and are found to potentially meet the criteria for participation in the RESET-RA Study, evaluating vagus nerve stimulation for RA, a multi-step process follows. The process will help determine your eligibility to participate in the study, equip you with the right information to make an informed decision, and, ultimately, enroll you in the study to implant the MicroRegulator device.
What are the initial steps involved in participating?
First, you’ll have a call with a healthcare professional at our call center to confirm your potential eligibility and interest in participating, and answer any questions you have at this time. The call center will then connect you with a study coordinator near you to schedule an appointment for you at your nearest study location. The study coordinator and doctor at the site will share more information with you about the study, and confirm your eligibility to participate. You’ll receive an informed consent form, complete symptom questionnaires, get interviewed by the study doctor, undergo a joint count exam to determine your current disease state, complete blood tests, and undergo diagnostic testing to evaluate your eligibility for the implant procedure.
All costs associated with this visit and the rest of your study participation will be covered by the study sponsor, even if you don’t choose to participate. If you complete the screening process and are found to be eligible for the study, your study site will schedule your implant procedure. The 60-90 minute procedure is performed while the patient is under general anesthesia by a surgeon with extensive experience in vagus nerve stimulation implant procedures.
What should I expect after the MicroRegulator is implanted to evaluate safety and effectiveness of vagus nerve stimulation for RA?
You typically return home a few hours after the procedure, and usually can resume activities of daily living the next day. A follow-up appointment will be scheduled with the surgeon for 14-21 days after the procedure.
MicroRegulator does not administer any drug into the body; rather, the device is designed to apply small electrical impulses to the vagus nerve for about one minute a day to activate the body’s natural immune response, which may treat RA (that’s what we’re investigating – vagus nerve stimulation for RA – in this study, thanks to patient participation!). Physicians use an iPad to individually program your MicroRegulator to turn on and deliver the therapy automatically every day, so there’s no need to remember to turn on the device.
The RESET-RA study has two phases. The first 12 weeks, or three months, is the “primary study,” during which you will be randomly assigned to either 1) the study treatment or 2) the control group, which does not receive the study treatment. After the primary study period ends, you can continue in the long-term phase of the study, during which all participants (including those who were in the control group) will receive the study treatment, and are also eligible to receive additional RA medications, including biologics or other DMARDs, as needed.
What this means is that you will receive the study treatment, but are not guaranteed to receive it in the first 12 weeks of the study. After implantation, you will have a 50/50 chance of being assigned to either control or treatment groups, but you will not be told your group assignment. (We have to have a control group, otherwise there would be no way to compare the new therapy to current treatments!)
Regardless of your group assignment during the first 12-week period, you will receive one minute of either active or non-active doses of stimulation each day and will be required to use your conventional DMARDs throughout the study. All participants will follow the same study procedures throughout their participation, including visiting the study site to program their device and complete various assessments, for a total of six visits over 12 weeks.
What happens after the 12-week primary study?
After 12 weeks, all participants – including those in the control group – can cross over to receive the study treatment and continue their participation in the long-term phase of the RESET-RA clinical trial for over three years. This means that you are now guaranteed to receive active doses of stimulation (study treatment) for the rest of the duration of the study. During this time, you will follow up with the rheumatology site every 12 weeks. Additionally, you will now be eligible to add other RA treatments into your regimen as needed.
You will receive payments for your time and travel during the course of the study. All costs of study-related procedures and assessments including implantation, programming, and removal (if needed) of the implant will be covered by the sponsor of the study.