THIS STUDY IS NO LONGER ENROLLING

Why is ANS sponsoring this trial?
Advanced Neuromodulation Systems (ANS) is sponsoring this trial to evaluate the safety and effectiveness of its Genesis™ Neurostimulation System in treating chronic migraine headaches. ANS has received an Investigational Device Exemption (IDE) from the FDA to conduct this clinical trial.

If you participate in the trial, you will

• Take an active role in healthcare research



• Help others by contributing to the medical community’s knowledge of migraines



• Possibly have your device costs covered by Medicare, private insurance, or ANS



• Receive reasonable compensation for your time

Do I qualify for this trial?

THIS STUDY IS NO LONGER ENROLLING

Only a doctor at a trial center can determine if you are eligible to participate in the trial. In general, to be eligible, you must:

• Be 18 years of age or older



• Have headaches that start in the back of your head and/or neck



• Have tried at least two migraine-specific medications that did not adequately relieve your symptoms



• Have had migraine symptoms for at least 15 days a month for the last three months

If I participate in the trial, what will I need to do?
You will be assessed to determine if you meet the clinical trial criteria. If so, you will be given a handheld electronic device that you will use to keep a headache diary for one month.

If you continue to meet the clinical trial criteria, you will return to the doctor’s office for a trial of the stimulation therapy. Depending upon the results of the trial, you may receive a peripheral nerve stimulation system.

You will be randomly assigned to one of two treatment groups for the first 12 weeks of the clinical trial. After that time, all participants will receive the same treatment.

In the year after implant, you will return to the doctor’s office, periodically, for check-ups and to answer questions about your headaches and general well-being.

What are the potential risks of participating in this trial?
This trial is designed to evaluate the safety and efficacy of a new treatment. All clinical trials involve some risks. There may be side effects or complications related to the therapy or device. There may also be other risks that are unknown.

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

Is it permanent?
If you find that the system does not adequately relieve your migraine headaches or that it is uncomfortable, the system can be turned off or removed at anytime.