Bion Occipital Nerve Stimulation (ONS) Compassionate Use Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic, Medically Refractory Headache

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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bion

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roshini Jain

Role: STUDY_CHAIR

Boston Scientific Neuromodulation Corporation

Locations

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Mayo Clinic Arizona

Phoenix, Arizona, United States

Site Status

Michigan Head Pain & Neurological Institute

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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A4005

Identifier Type: -

Identifier Source: org_study_id

G030225/S022

Identifier Type: OTHER

Identifier Source: secondary_id