Frequently Asked Questions
Some of the most frequently asked questions
Click on the question to get your answer.
What are the symptoms of depression?
Depression is one of the most common illnesses in the United States. It affects 7% of the adult population.
Symptoms are not the same for every person, but often include:
- Feeling sad, empty or hopeless
- Sudden anger, feeling irritable or frustrated
- Loss of interest in life and things they do every day
- Trouble sleeping
- Feeling very tired or a lack of energy
- Changes in eating habits
- Feeling worthless
- Unexplained physical problems
- Trouble concentrating
- Thoughts of death or suicide
What is a clinical research study?
A clinical research study (also called a clinical trial) is a medical study that helps to answer important questions about a drug or device, such as: “How well does it work?” or “Does it cause side effects?” or “How effective is it compared to another drug/device?”
Some clinical trials research new treatments. Others, like the RECOVER study, want to learn more about a treatment that has already been approved by the FDA and prescribed to patients.
What can you expect from The RECOVER Study?
The RECOVER Study will last about 12 months, with another long-term follow-up period of 4 years. First, you will be invited to visit a study clinic in your area. At this visit, you will get details about the study and the medical team will find out if the study is right for you.
If you are in the study, you will go to at least 22 visits at a study clinic in your area. At these visits you be asked questions and fill out forms about how you are feeling, your overall health and about your experience with VNS Therapy.
Everyone in the study will get VNS Therapy. However, people in the study will be put into 2 groups, Group A and Group B. Group A will have VNS Therapy turned on at the beginning of the study. Group B will have VNS Therapy turned on after 12-months. There is an equal chance of being in Group A or B. No one, including your doctor, will know which group they are in. Your group will be chosen at random, like flipping a coin.
Is there a site near me?
Map/list of study locations
Royal Palm Beach, FL
Costa Mesa, CA
Oklahoma City, OK
Ann Arbor, MI
Santa Ana, CA
Missouri City, TX
Additional sites added as they are activated.
Why do I need to visit the study site?
For the first 12 months of the study, you will be asked to visit the study center regularly, no matter which group you are put in. At these visits, your current mood and health will be checked.
The device settings may also be adjusted. At later visits, you will be asked to fill out forms and answer questions about your mood, health and daily life.
You will also be asked about your experience with VNS Therapy.
Does being in the study cost anything?
Medicare, including Medicare Advantage and TriCare for Life (TFL), are currently the only health plans that provide reimbursement for the RECOVER trial. If you have one of these insurance types, you will get VNS Therapy and all study-related care at no cost to you.
If you do not have Medicare or Medicare Advantage and wish to access VNS Therapy LivaNova has a program that can help. Please visit our website @ https://symmetryvns.com/where you will find more information about the services we offer.
Will I be paid for being in the study?
You will be paid for each study visit you complete.
Can I still see my doctor if I join the study?
You can still see your current psychiatrist or doctor.
Can I still use my current treatments if I am in the study?
Yes. In fact, it is best not to change your current treatments in the first 12 months of the study. But if your doctor does decide to change them, it is important to let the study staff know right away.
Please note: If you are woman who can become pregnant, you will need to use a reliable method of birth control during the study to avoid a pregnancy.
What are my rights as a study participant?
Choosing to take part in the RECOVER Study is up to you. You will still be able to get your usual medical care, no matter what you decide.
- You will get all study-related care, including the cost of the VNS Therapy device, at no cost to you. You also will be paid for each study visit you complete.
- Your privacy and confidentiality will be protected.
- Even if you join the study, you are free to leave at any time without giving a reason.
Why is it important to stay in the study?
The more people who complete the study, the better the chance that the study will provide useful information about VNS Therapy.
This information may help insurance companies decide to pay for it. The study team will help you in any way they can to make the visits as easy as possible for you.
Your safety and comfort will always be their top concern.
What happens if I sign up?
If you think you might like to join the RECOVER Study or would like to know more, please check if you qualify by clicking on the sign-up button.
Signing up for the study does not obligate you to participate, even if you qualify.
Your information is confidential and will not be shared with anyone outside of the study.
What happens if I qualify for the study?
If you qualify, you will choose a study clinic in your area to visit during the study. The study team will reach out to tell you more about the study before you decide if you want to join.
You will go to an in-person visit where the study team will help find out if you qualify and if the study is right for you. Even if you qualify, it is up to you whether or not to participate and you can withdraw at any time.