Bion Occipital Nerve Stimulation (ONS) Compassionate Use Study

Boston Scientific Corporation11 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic, Medically Refractory Headache

Interventions

bionDEVICE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (2)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Michigan Head Pain & Neurological Institute

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Provision of one year of clinical and technical support

This is a compassionate use study. There are no primary outcome measures.

Data from ClinicalTrials.gov

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