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 whether the Libra™ DBS system suppresses of some of the symptoms of Parkinson’s.

Do I qualify?

The clinical study has rules that specify who can participate in the study. The doctors and nurses at the clinical study centers are familiar with these rules and will use them to determine if you are able to participate in the study.

What are the potential benefits of participating in this study?

If you participate in this clinical study, you will

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

What are the risks of participating in a clinical study?

Clinical studies are designed to evaluate the safety and efficacy of new treatments. All clinical studies involve some risk. There may be side effects or complications to the therapy or device. There may also be other risks that are currently unknown.

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.

Only doctors with significant DBS therapy experience have been selected for this study. Collectively, the doctors in this study have performed more than 2,000 DBS procedures.

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 neurostimulator on or off.

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

If you participate in 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 periodic visits to the movement specialist to assess how well your therapy is working and to adjust your therapy as needed.

Who is ANS?

ANS (Advanced Neuromodulation Systems), the company sponsoring this clinical study, is the technology leader in implantable neurostimulation therapies. ANS has nearly 20 years of experience, numerous technological firsts, multiple awards for excellence in product design and business, and more than 25,000 patients in over 25 countries with ANS neurostimulators for chronic pain management. ANS’ mission is to improve the lives of the millions of people around the world who suffer with disabling pain or nervous system disorders. To learn more about ANS, visit www.sjmneuro.com.

In 2005, ANS became a St. Jude Medical company. St. Jude Medical is a leading manufacturer of pacemakers, implantable defibrillators, and heart valves. Over 1 million mothers, fathers, grandparents, and children worldwide have received a life-saving St. Jude Medical device. To learn more about St. Jude Medical, visit www.sjm.com.