Bion Occipital Nerve Stimulation (ONS) Compassionate Use Study
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of this compassionate use study is to provide clinical and technical support of the Bion® microstimulator system to the subjects who have decided to keep the system for relief of headache symptoms that have not responded to medical treatment. These study subjects were enrolled and implanted with the Bion® system during a previous clinical investigation of the Bion® for occipital nerve stimulation (ONS) in the United States.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects who were enrolled and implanted with the Bion® system during a prior feasibility clinical investigation of the device for occipital nerve stimulation (ONS) in the United States.
Subject participated in a prior clinical feasibility study of the Bion for occipital nerve stimulation in the treatment of chronic headaches (IDE G030225) and remained implanted with the Bion system.
Subject elects to enroll in this compassionate use study and provides written informed consent.
Subject understands the type and duration of clinical, technical or product support provided in the study.
Subject is willing to comply with protocol-required activities.
Subject is currently participating or intends to participate in another investigational drug or device clinical trial for chronic headaches during the study period.