Bion Occipital Nerve Stimulation (ONS) Compassionate Use Study

Completed

Conditions studied: Chronic, Medically Refractory Headache

In brief

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.

Key facts

Study ID

NCT01050959

Run by

Boston Scientific Corporation

People needed

11

Starts

2010-01-01

Expected to finish

2011-04-01

Last updated by the study team

2020-11-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subject is currently participating or intends to participate in another investigational drug or device clinical trial for chronic headaches during the study period.

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States
• Michigan Head Pain & Neurological Institute — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.