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?
- 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?
What are the screening procedures to determine my eligibility to participate in 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?
What should I expect for the implant procedure?
What should I expect with vagus nerve stimulation?
What are the benefits of participating in the study?
What are the possible risks and discomforts?
What does the implant scar look like?
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?
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.
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.
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).
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.
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).
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.
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.
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.
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.