One out of three people with depression, or bipolar depression, have what is called ‘treatment resistant’ depression, or ‘difficult-to-treat’ depression. This means they have tried several treatments without success.

Even if several types of treatment haven’t worked for you – or have not worked well enough – there is still a chance that something else will.

The RECOVER Study is a research study that will provide new information about how helpful the VNS (Vagus Nerve Stimulation) Therapy® System is for patients with bipolar depression that has been difficult to treat.

VNS Therapy was approved by the FDA as a safe and effective treatment option for treatment resistant depression in 2005. It has been tested in several research studies and prescribed for more than 4,000 depression patients across the United States, which means doctors and patients already have experience with it.

Benefits of VNS Therapy1

Results with VNS Therapy + traditional treatment are better than with traditional treatment alone.

Results with VNS Therapy get stronger over time


Nearly 7 in 10 people significantly improved with VNS Therapy


Nearly 4 in 10 people fully or almost fully recovered

VNS Therapy provides significant, sustained quality of life improvement when added to traditional treatment.2

  • Sexual Function

  • Vitality

  • Emotional Wellbeing

  • Mental Health

  • Social Functioning



People who added VNS Therapy to their traditional treatments had sexual function scores that improved each year for 5 years. These scores generally worsened in patients receiving only traditional treatment.3

Patients receiving VNS Therapy with traditional treatments were 2X less likely to have suicidal thoughts than those using traditional treatments alone.1

A separate data analysis looking only at outcomes for those with bipolar depression found that

Patients experience reduction in depression Symptoms6

and

fully or almost fully recovered from their depression Symptoms5

fully or almost fully recovered
from their depression symptoms when VNS Therapy was
added to their usual treatment versus the usual treatment
alone1

VNS Therapy™ is safe and well tolerated
VNS Therapy is not a drug Does not cause the same side effects that antidepressant medications can cause, including:

  • Fatigue
  • Sedation
  • Weight gain
  • Dry Mouth

Does not cause the same side effects as other medication-free treatments can cause (e.g., ECT, TMS) including:

  • Memory loss
  • Drowsiness
  • Poor concentration

The most common side effects of VNS Therapy include voice changes (hoarseness), prickling or tingling in the skin, sore throat, and breathlessness. Side effects typically occur only when the pulses are being transmitted, and are noticed less as time goes on.

Although VNS Therapy is FDA-approved and has been shown to help people with treatment-resistant depression, Medicare only covers it for patients enrolled in the RECOVER Study, and other insurance companies don’t always cover it.

To change this, many of the nation’s top depression experts worked together to help design the RECOVER Study. If the results are like past studies, this may provide the proof Medicare and insurance companies need to start to cover it.

The RECOVER Study

  • Up to 1,000 people who have depression or bipolar depression that has been difficult to treat will take part in the study.
  • The study will be carried out at up to 100 leading hospitals and medical centers across the United States.
  • Option 1: If you choose to participate, and have Medicare insurance, you will not have to pay for VNS Therapy or for any study-related care.
  • Option 2: If you choose to participate you will not have to pay for VNS Therapy or for any study-related care.
  • By participating, you could help many other people with treatment resistant bipolar depression to gain access to VNS Therapy in the future.
See if you qualify – Complete the questionnaire

Who can take part in the RECOVER Study?

To join the RECOVER Study, you must be 18 years or older and:

  • 1
    Currently depressed.
  • 2
    Have depression, or bipolar depression, that has lasted for at least two years or recurred several times.
  • 3
    Have tried at least four treatments and not found them helpful.
If you are over the age of 18 and have been suffering from bipolar depression, that has lasted at least two years, or has recurred multiple times, you may be eligible to take part in the RECOVER Study.
Participate
Participate
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Who can take part
VOLUNTEERS WHO TAKE PART IN THE STUDY MAY BE ELIGIBLE TO RECEIVE COMPENSATION FOR THEIR TIME AND TRAVEL.
 

About VNS Therapy

VNS stands for ‘Vagus Nerve Stimulation’. VNS Therapy is an approved treatment for people with depression, and bipolar depression, who have not been helped enough by several other types of treatment, such as antidepressant medications (pills and tablets), antidepressant nasal sprays, psychotherapy (talk therapy), repetitive trans-magnetic stimulation (rTMS) and electroconvulsive therapy (ECT).

  • 1. VNS Therapy uses a small device that is put under your skin just below your collarbone
  • 2. A surgeon implants it during a short outpatient procedure
  • 3. Most people go home the same day
How does VNS Therapy work:
  • 1. VNS Therapy works by sending out mild pulses to the vagus nerve in your neck
  • 2. The vagus nerve is connected to areas of the brain associated with controlling mood
  • 3. From there, these pulses use the natural pathways in your body to travel up to your brain and help you to feel better
VNS Therapy is not a drug.

It does not cause the same side effects as antidepressant medications

  • 1. Fatigue
  • 2. Sedation
  • 3. Weight gain
  • 4. Dry mouth

It does not cause the same side effects as other medication-free treatments, like ECT and TMS

  • 1. Memory loss
  • 2. Drowsiness
  • 3. Poor Concentration
References:
  • 1. Aaronson ST, Sears P, Ruvana F, et al. Am J Psychiatry. 2017;174:640-48.
  • 2. Conway CR et al, J Clin Psychiatry 2018
  • 3. VNS Therapy Physician’s Manual, LivaNova
  • 4. DSM-IV Criteria for Major Depressive Disorder (MDD)
  • 5. RECOVER Clinical Study Physician Participation
  • 6. Kaptchuk TJ et al BMJ (2008)

Frequently Asked Questions

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.

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, participants 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.

Things to consider

  • By joining the RECOVER Study, you have a chance of benefiting from an FDA-approved treatment for your depression that is not generally available unless you pay for it yourself.
  • By joining, there is a possibility that your symptoms of depression will improve, or even resolve. You may experience an improved quality of life.
  • Once activated, you will receive a continuous antidepressant therapy that’s always with you.
  • By taking part in the study, you might also be helping other people like you to access this treatment in the future.
  • If you are in Group A of the study, your VNS device will be turned on from the start. After 12 months, both groups will have their VNS device turned on for the remaining four years of the study.
  • Being in a research study may mean you will get more healthcare attention than you would get outside of a study. For some people, this increased attention can be beneficial.6
  • Whichever group you are in, you can continue to use your usual medication or therapies.
  • Whichever group you are in, you’ll need a short outpatient surgical procedure to implant the device.2
  • There is a 50/50 chance you will be in Group B. This means that, although you will receive a VNS device, active treatment will be delayed for the first 12 months of the study.
  • The surgical procedure and stimulation from the device may sometimes cause side effects (unwanted changes in your health).3 Side effects are a risk with all medical treatments. The most common side effects from stimulation include voice changes (hoarseness), prickling or tingling in the skin, sore throat, and shortness of breath. These tend to become less noticeable over time. The most commonly reported side effect from the implantation procedure is infection (<1%).3 The study team will discuss the possible side effects with you but won’t be able predict what side effects you may get and how troublesome these may be.

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.

Option 1: Medicare, including Medicare Advantage and TriCare for Life (TFL), are currently the only health plans that provide reimbursement for the RECOVER Study.  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.

Option 2: If you qualify, and decide to participate in the study, VNS Therapy and all study related care will be provided to you at no cost.

Yes, you will be paid for each study visit you complete.

Yes, you can still see your current psychiatrist or doctor.

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.

Choosing to take part in the RECOVER Study is entirely your decision. You will still be entitled to receive your usual medical care, whatever you decide.

  • VNS Therapy and all study related care will be provided at no cost to you
  • You will receive compensation for each study visit you complete.
  • All necessary steps will be taken to protect your privacy and confidentiality.
  • Even if you join the study, you are free to leave at any time without having to give a reason.

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.

Sign Up

What happens if I Sign Up? If you think you might like to join the RECOVER Study or would like more information, please enter your information below so we can see if you qualify.

What happens if I qualify for the study? If you qualify, we will match you to a study clinic in your area that is seeking participants or notify you when a study clinic becomes available. The study team will contact you to explain more about the study before you make your decision about participating. You will attend an in-person visit where the study team will help determine if you qualify and if the study is right for you. Even if you qualify, it is up to you whether to participate and you can withdraw at any time.

This Screening tool is for US residents only. If you are not a US resident, please do not complete this form.

©2020 LivaNova USA, Inc., a wholly-owned subsidiary of LivaNova PLC. All rights reserved. VNS Therapy® is a registered trademark of LivaNova USA, Inc.

Health Care Providers

If you are a Health Care Provider that would like more information about the RECOVER Study, please enter your information below and one of our LivaNova representatives will contact you as soon as possible.