Frequently Asked Questions

Has this device been studied in humans before?

So far, the MicroRegulator device has been implanted in over 70 patients in two clinical studies across various sites in the US, however, its safety and effectiveness are still being evaluated. The RESET-RA Study is being conducted to evaluate the MicroRegulator in more people.

Who can participate in this study?

If you have tried multiple medications and continue to experience symptoms of RA, such as joint pain and swelling, you may be eligible for the RESET-RA study. Study participants must meet the following initial requirements in order to be further evaluated for participation:

Be 22-75 years of age
Have been diagnosed with RA as an adult
Have active moderate to severe RA
Are currently taking a conventional synthetic DMARD.
Have received at least one biologic DMARD (biologics) for RA that was either not effective or was not tolerable.
Are willing to undergo an investigational vagus nerve stimulation implant procedure

This study will enroll over 200 people altogether at multiple study sites across the United States. See if you qualify.

What do I need to do to determine whether or not I am eligible for the RESET-RA Study?

Click here to take a questionnaire for the study. If you qualify in the online questionnaire, you will be connected to a health care professional who can provide you with more information and refer you to the nearest study site. A study rheumatologist at the study site will ultimately determine your eligibility to participate in the study and guide you through the process.

What are the screening procedures to determine my eligibility to participate in the study?

After you agree to participate in the study and sign the informed consent form, you will undergo the following screening procedures to determine if you are eligible for the study:

Interview by the study doctor
Complete symptom questionnaires
Undergo a joint count exam and wrist MRI scan to determine your current disease state
Undergo blood tests to evaluate your eligibility for the implant procedure

Am I guaranteed to receive treatment?

All patients will have the opportunity to receive the study treatment, but not all will receive the study treatment during the first three months. During the first three months of the study, patients will be randomly assigned to either the study treatment group or the control group. All participants, regardless of their treatment assignment, will be required to use their csDMARD RA medication.

See this article to learn more about the factors that people commonly consider when deciding to participate in a clinical study.

At three months, all participants from both the treatment and control groups can continue in the long-term phase of the study, during which all participants will receive the study treatment, and are also eligible to receive additional RA medications, including biologics or other DMARDs, as needed.

Can I take my RA medications during the study?

All participants will be required to use their conventional DMARDs throughout the study. After three months, participants can also add other RA treatments, including biologics, based on their rheumatologists’ recommendation.

What should I expect for the implant procedure?

The implant procedure is done under general anesthesia in an outpatient setting. This means that patients typically return home a few hours after the procedure. Patients typically resume activities of daily living the day after the procedure, and follow-up with their study surgeon 14-21 days after the procedure for post-operative clearance.

What should I expect with vagus nerve stimulation?

Once the device is programmed, it will automatically deliver one minute of stimulation daily at a predetermined time. Everyone has a different level of sensitivity to stimulation. Participants may or may not feel any sensation during stimulation; this is normal and does not indicate whether or not they are in the study treatment group. The study site will ensure that if participants do feel something, that the stimulation is comfortable for them.

What are the benefits of participating in the study?

Each participant in the study is a partner in research and plays an important role in advancing the treatment choices for RA.

By taking part in the RESET-RA investigational study, you can try this new RA treatment. While no benefit is guaranteed, we hope the information learned from this research study will benefit other individuals with RA in the future.

What are the possible risks and discomforts?

Like all clinical research studies, there are some risks associated with the RESET-RA study, including that the safety profile of the investigational vagus nerve stimulation device is currently unknown, and being evaluated in this study.

While the devices and indications are different, there are learnings from more than 100,000 patients in the US, who have undergone implantation

of vagus nerve stimulation devices for treatment of epilepsy or depression over the past 20 years.

Some patients implanted with these commercially-available vagus nerve stimulation therapy systems have reported experiencing pain, redness and swelling at the implantation site, typically for a few days after the procedure. Rarely, vagus nerve implantation patients experience an infection, excessive bleeding or damage to the vagus nerve, which can lead to voice, breathing or swallowing difficulties. In some patients, stimulation of the vagus nerve may trigger symptoms such as sore throat, hoarseness, cough, nausea, dizziness, tingling or numbness near the implantation site for a few days after the procedure.

If you proceed with participation in the study, your physician will review the Informed Consent Form with you, which lists the possible risks and benefits associated with the device and the RESET-RA study, and can discuss any questions you may have with you.

What does the implant scar look like?

The scar is usually 1-2 inches on the left side of the neck and hidden within a crease in the skin. Scar lengths and locations may vary from person to person.

Click here to see examples of typical scars three months following surgery.

Who will pay for the procedure?

Participants will be compensated for their time and travel associated with their participation in the study. Once you are connected with the study site, they can share the details about payment with you. Payments are based upon the number of visits and duration of your participation in the study.

All costs of study-related procedures and assessments including study doctor visits, implantation, programming, and removal (if needed) of the implant will be covered by the sponsor of the study.

Can I withdraw from the study?

Taking part in this study is voluntary. You can withdraw your consent or discontinue participation in the study at any time. Your decision to leave the study will not cause any loss of benefits to which you are entitled. If you choose to discontinue participation, you can have the implant permanently turned off or removed.

Glossary Of Terms

We understand that the decision to participate in a clinical study requires you to consider a number of factors. The scientific language used is often hard to understand, so here is a glossary of some key scientific terms that come up throughout this site and in this area of medicine and research.

Blinded:
A blinded study is often used in studies which compare two different treatments. Blinding prevents the participant and the physician from knowing certain information about their treatment that might influence their impressions when evaluating the effectiveness of the treatment. The RESET-RA Study is a double-blinded study. This means that both the participants and the study staff do not know which treatment the participants will receive during the first 12 weeks. After 12 weeks, all participants will receive the study treatment. However, the original treatment assignment will not be disclosed until the study is over.

Randomized:
A randomized study design randomly assigns participants in the study to either the control or the treatment group – meaning that the participant or the study staff does not control which group one is assigned to. A randomized design is used to prevent stacking the study groups in a way that would favor one group over the other. All participants in the RESET-RA Study will be randomized into a treatment or control group. This means that they will have a 50:50 chance to either receive the study treatment (active doses of stimulation) or recieve the control (non-active doses of stimulation).

Treatment Group:

A treatment group is a group of patients in a clinical study that receives the treatment being studied, so that comparisons can be made between the control and treatment groups. Vagus nerve stimulation is the treatment being investigated in the RESET-RA Study. Participants assigned to the treatment group will receive active doses of vagus nerve stimulation.

Control Group:

A control group is a group of patients in a clinical trial that receives only the currently available standard of care treatment, and does not receive the treatment being studied for a certain period of time. This is done so that comparisons can be made between the two patient groups. For example, in the RESET-RA study, half of the patients will be in the control group and will receive non-active doses of stimulation for the first three months. The control group will continue to take their conventional DMARD, which is the standard medication for RA, and will undergo the same level of care as the patients who are assigned to the treatment group. The results of the control group will be compared to the results of the treatment group, and that data will be used to determine if MicroRegulator is effective in treating the disease. Without the control group, there would be no way to compare the new treatment to the current treatment options. After 3 months, the patients in the control group will have the option to enroll in the long-term study (cross over) and receive active doses of stimulation (study treatment).

FDA:

The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. The FDA is responsible for protecting public health through the regulation and supervision of health products like pharmaceutical drugs, vaccines, medical devices and veterinary products. The FDA has approved the study device (MicroRegulator) to be used as part of an investigational clinical trial to evaluate its safety and effectiveness.

Investigational:

The device being evaluated in the RESET-RA clinical study is considered investigational because it is being evaluated for its safety and effectiveness. It is not approved by the United States Food and Drug Administration (FDA) for commercial use. The data collected in the RESET-RA clinical study is intended to be used to obtain FDA approval for this device.

Multi-Center:
A multi-center study is conducted at more than one site of patient care. For example, the RESET-RA study will enroll patients at up to 40 study sites in the USA. Multiple centers of study ensure that the study enrolls participants who are from various geographic locations and are represented by different ethnic groups and gender.

IRB:

An Institutional Review Board (IRB), also known as an independent ethics committee or ethical review board, is a committee that approves, monitors, and reviews biomedical and behavioral research involving humans. The purpose of an IRB review is to ensure that appropriate steps are taken to protect the rights and health of patients in a research study. The RESET-RA study has been approved by the IRB of the participating study sites.