CompletedNot Applicable

Bion Occipital Nerve Stimulation (ONS) Compassionate Use Study

United States11 participantsStarted 2010-01

Plain-language 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.

Who can participate

SexALL

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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.

What they're measuring

Provision of one year of clinical and technical support

Trial details

NCT IDNCT01050959

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2011-04

View on ClinicalTrials.gov More Chronic, Medically Refractory Headache trials