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Occipital Nerve Stimulation to Treat Chronic Headaches

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. Identifier: NCT00205894
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 5, 2008
Information provided by:
Boston Scientific Corporation

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of a implantable device, called the bion(R), in the treatment of chronic headache. The bion microstimulator is placed underneath the skin next to the greater occipital nerve. The bion microstimulator then stimulates the nerve by generating small amounts of electrical current.

Condition or disease Intervention/treatment Phase
Headache Disorders Device: bion microstimulator Phase 1 Phase 2

Detailed Description:

Chronic migraine and chronic cluster headaches are among the most disabling medical illnesses, inflicting severe functional impairment. These headache subtypes are particularly resistant to current treatment modalities, with the majority of chronic migraine patients continuing to experience frequent or near-daily headaches despite aggressive, multidisciplinary, and multimodal therapy. The refractory nature of these illnesses and the level of devastation they inflict on the lives of their victims has motivated the pursuit of novel treatment approaches.

Direct stimulation of the greater occipital nerve has been shown to alleviate the symptoms of chronic migraine and chronic cluster headaches in a small number of patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Feasibility Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches
Study Start Date : January 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Primary Outcome Measures :
  1. The primary safety measure is the incidence of major complications, defined as device or procedure related major adverse events that require medical and surgical intervention.
  2. The primary efficacy measure is a significant reduction in the frequency, severity or duration of the headaches from the preoperative to the three-month follow-up period.

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Be diagnosed with chronic migraine, probable chronic migraine, and/or chronic cluster headache according to the 2004 IHS Classification Criteria (2nd ed.) or be diagnosed with migraine with or without aura
  2. Be 18 years of age or older
  3. Be willing and able to follow all study-related procedures during the course of the study;
  4. Have exhibited refractoriness to two acute medication regimens and two prophylactic medications from two separate preventative 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 affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade currently in effect;
  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 within the next 4 months in a 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; and
  8. Currently require, or be likely to require, MRI or diathermy.

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 identifier (NCT number): NCT00205894

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United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, Michigan
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
Boston Scientific Corporation
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Principal Investigator: David Dodick, MD Mayo Clinic
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pam Phongpharnich, Sr. Clinical Research Associate, Boston Scientific Identifier: NCT00205894    
Other Study ID Numbers: CR-B-003
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 5, 2008
Last Verified: August 2008
Keywords provided by Boston Scientific Corporation:
Chronic headache
Cluster headache
Additional relevant MeSH terms:
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Headache Disorders
Neurologic Manifestations
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases