Answers to Your Questions

Everything you need to know about participation in the Libra™ Deep Brain Stimulation for Essential Tremor Clinical Study.

A clinical study involves treating and following a group of participants to see if a particular therapy is a safe and effective way of treating a specific condition. The FDA (Food and Drug Administration) approves and regulates clinical studies in the United States. ANS, the clinical study’s sponsor, has received FDA approval for this clinical study to evaluate the Libra® DBS system for the treatment of essential tremor.

ANS is performing this study of its device, the Libra DBS system, for people with essential tremor of the arm and/or hand that is not adequately controlled by drugs.

The study will be open to approximately 160 participants at approximately 12 sites in the United States. All participants will be implanted with a neurostimulator and followed for 12 months, with long-term follow-up until the device is approved or the study is stopped. In addition to having tremor of the arm or hand that is not adequately controlled by drugs, participants must have been diagnosed with essential tremor at least 3 years ago and must be at least 18 years old. Participants can continue to receive their tremor medications, as needed, while participating in the study. 

What is a clinical study?

A clinical study involves treating and following a group of participants to see if a particular therapy is a safe and effective way of treating a specific condition. The FDA (Food and Drug Administration) approves and regulates clinical studies in the United States.

Advanced Neuromodulation Systems (ANS), the clinical study’s sponsor, has received FDA approval for this clinical study to evaluate the Libra® DBS system for the treatment of essential tremor.

Do I qualify?

The clinical study has rules that specify who can participate in the study. The doctors and nurses at the clinical sites are familiar with these rules and will use them to determine if you are able to participate in the study. Click here to learn more about some of the rules or to take an on-line pre-screening questionnaire to see if you qualify for the study.

Why should I participate?

If you are selected to participate in this clinical study, you will

• Work with a highly experienced DBS team in your area
• Advance the fight against essential tremor by increasing the medical community’s knowledge about DBS for essential tremor
• Take an active role in your own healthcare
• Possibly pay less out of pocket
• Receive reasonable compensation for your time and expenses

Will my insurance pay for this?

Insurance typically covers DBS therapy, however you will want to get a prior authorization for the therapy from your insurance company. ANS and your doctor’s staff can help you work through the entire process.

This clinical study has been designated investigational/ non-experimental by the FDA. Under a September 8, 1995 agreement between the FDA and HCFA (now known as CMS, the Center for Medicare & Medicaid Services), such treatments can be covered under Medicare if all other applicable Medicare coverage requirements are met. All Medicare carriers now cover DBS therapy under a national coverage decision issued on April 1, 2003. Prior authorization is not necessary with Medicare. Your standard inpatient deductible, outpatient co-payment, and physician services co-payment apply. These costs may or may not be covered by your Medicare co-insurance.

Most private insurance plans follow Medicare coverage decisions.

Are clinical studies regulated?

In addition to the legal and ethical codes that they follow every day as they practice medicine, doctors must also follow strict regulations that the FDA has put in place for clinical studies. Some of these include

• Every clinical study in the United States must be reviewed and approved by each participating medical center’s IRB (Institutional Review Board). The IRB’s responsibility is to make sure the risks are as low as possible.



• All potential participants must be given an Informed Consent form, which provides detailed information about the study procedures, risks, and potential benefits. Doctors and nurses are available at each site to answer all participants’ questions before they make their decision to join the study.

Why is DBS therapy being studied for the treatment of essential tremor?

Advanced Neuromodulation Systems is conducting this study to evaluate whether its Libra® DBS system controls essential tremor.

What is the Libra® DBS System?

The Libra® DBS System is a family of devices that are designed to work together to stimulate the brain with mild electrical pulses. The Libra system looks and operates much like a pacemaker, except that instead of sending pulses to the heart, it sends pulses to the brain.

The Libra system includes a neurostimulator, lead, and extension that are implanted during surgery.

In addition to the implanted components, the Libra DBS system includes a programmer and a controller, which are not implanted. The programmer is used by a doctor or nurse to customize the stimulation produced by the neurostimulator. All participants in the study will also receive a handheld device called a controller. The controller enables participants to turn their stimulation on or off.

What do I have to do if I join the study?

If you are selected to join the study, you will be examined by a movement disorder specialist and a neurosurgeon to assess your suitability for, and to prepare you for, DBS therapy. You will undergo surgery to receive a Libra DBS system. After surgery, you will make 3 visits to the movement specialist over a period of 12 months to assess if your therapy is working and to adjust your therapy as needed.

For more details about the study procedures, contact a participating clinical study site.

Can you describe the surgery?

Before surgery, magnetic resonance imaging (MRI) or computed tomography (CT) will be used to create a map of the brain and to locate the appropriate stimulation site. A stereotactic frame will be used to keep the head still during surgery and to guide the lead into place. During surgery, the surgeon will turn stimulation on to be sure that the lead is in the correct location. When the surgeon is satisfied that the lead is in the right place, the lead will be secured.

The surgeon will place the neurostimulator in a small pocket that he creates in the chest (about where your hand goes when you say the pledge of allegiance). The extension is routed under the skin to connect the neurostimulator to the lead.

The brain itself has no pain receptors and feels no pain. However, as typical of any surgery, participants are likely to have postoperative pain in the areas around their incisions. The hospital staff is able to help with this and other aspects of postoperative care.

How do I join the study (or get more information)?

Contact a site that is participating in the clinical study. The staff at the site can explain the trial and determine if you are a candidate.