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Bion for Occipital Nerve Stimulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205829
First Posted: September 21, 2005
Last Update Posted: August 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose
This is a prospective, single-centre, cross-over study designed to evaluate the safety and efficacy of using the bion, an implantable medical device, for the treatment of chronic headaches. The clinical study is proposed to determine the anticipated adverse event rate and treatment outcomes at the conclusion of the study. Each trial subject will serve as his/her own control.

Condition Intervention Phase
Chronic Headaches Device: battery-powered bion(R) microstimulator system Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bion for Occipital Nerve Stimulation

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Demonstrate acceptable rate of adverse events. [ Time Frame: Throughout the Study ]
  • The primary efficacy measure is a significant reduction in either headache frequency or severity [ Time Frame: 4 months Post-Activation Visit ]

Enrollment: 10
Study Start Date: June 2004
Study Completion Date: January 2009
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Therapy
Occipital nerve stimulation (ONS) therapy delivered to a subject implanted with a bion ONS device
Device: battery-powered bion(R) microstimulator system
Stimulation on from initial activation and on.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be diagnosed with chronic migraine or primary chronic daily headache
  2. Have headaches characterized by pain
  3. Be 18 years of age or older;
  4. Be willing and able to follow all study-related procedures during course of study;
  5. Have exhibited refractoriness to two acute medication regimens and two prophylactic medications from two separate preventive classes.

Exclusion Criteria:

  1. Have received a botulinum toxin (botox) injection for treatment of headache within the last 90 days;
  2. Have previously undergone destructive ganglionectomy
  3. Have had a previous surgery in the intended implant area;
  4. Have Arnold-Chiari malformation;
  5. Have participated within the last 30 days or plan to participate during this study in another device or drug trial;
  6. Be pregnant or planning on becoming pregnant during the study period;
  7. Have an implanted electrical device (e.g., pacemaker, spinal cord stimulator) that may interfere with this therapy;
  8. Demonstrate significant psychological signs, substance abuse symptoms, or behavioral problems on examination and/or history that, in the investigator's judgment, render them inappropriate for the study;
  9. Currently require, or be likely to require, diathermy;
  10. Have other medical conditions that the investigator believes would confound the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205829


Locations
United Kingdom
University College London - Institute of Neurology
London, United Kingdom, WC IN 3BG
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Peter J. Goadsby, MD University College London Hospitals
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00205829     History of Changes
Other Study ID Numbers: CR-B-(E)-003
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: August 2, 2012
Last Verified: July 2012

Keywords provided by Boston Scientific Corporation:
Chronic headaches
greater occipital nerve stimulation

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