Bion Occipital Nerve Stimulation (ONS) Compassionate Use Study
Completed
- Conditions
- Chronic, Medically Refractory Headache
- Registration Number
- NCT01050959
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria
- 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.
Exclusion Criteria
- Subject is currently participating or intends to participate in another investigational drug or device clinical trial for chronic headaches during the study period.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Provision of one year of clinical and technical support This is a compassionate use study. There are no primary outcome measures.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Michigan Head Pain & Neurological Institute
🇺🇸Ann Arbor, Michigan, United States