Bion Occipital Nerve Stimulation (ONS) Compassionate Use Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01050959
First received: January 14, 2010
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Chronic, Medically Refractory Headache
Device: bion

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Compassionate Use Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Provision of one year of clinical and technical support [ Designated as safety issue: No ]
    This is a compassionate use study. There are no primary outcome measures.


Enrollment: 11
Study Start Date: January 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects who were enrolled and implanted with the Bion® system during a prior feasibility clinical investigation of the device for occipital nerve stimulation (ONS) in the United States.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050959

Locations
United States, Arizona
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
United States, Michigan
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Chair: Diana Bowers Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01050959     History of Changes
Other Study ID Numbers: A4005, G030225/S022
Study First Received: January 14, 2010
Last Updated: November 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014