A clinical trial is a carefully designed scientific study that involves treating and following a group of volunteers to see if a particular therapy is a safe and effective way to treat a specific condition.

In the United States, the U.S. Food and Drug Administration (FDA) approves and regulates clinical trials. ANS, the trial sponsor has received an investigational device exemption (IDE) from the FDA to conduct this clinical trial to evaluate peripheral nerve stimulation in the treatment of chronic migraine headaches.

A total of 150 participants will be enrolled at centers across the United States.

Only a doctor at a trial center can determine if you are eligible to participate in this clinical trial. If you decide to participate:

• 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.