Occipital Nerve Stimulation to Treat Chronic Headaches - Full Text View

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00205894

Purpose

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	Intervention	Phase
Headache Disorders	Device: bion microstimulator	Phase I Phase II

MedlinePlus related topics: Headache

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Multicenter Feasibility Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

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.
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.

Enrollment:	20
Study Start Date:	January 2004
Study Completion Date:	September 2007
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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
Be 18 years of age or older
Be willing and able to follow all study-related procedures during the course of the study;
Have exhibited refractoriness to two acute medication regimens and two prophylactic medications from two separate preventative classes.

Exclusion Criteria:

Have received a botulinum toxin (botox) injection for treatment of headache within the last 90 days;
Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade currently in effect;
Have had a previous surgery in the intended implant area;
Have Arnold-Chiari malformation;
Have participated within the last 30 days or plan to participate within the next 4 months in a device or drug trial;
Be pregnant or planning on becoming pregnant during the study period;
Have an implanted electrical device (e.g., pacemaker, spinal cord stimulator) that may interfere with this therapy; and
Currently require, or be likely to require, MRI or diathermy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205894

Locations

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

Investigators

Principal Investigator:

David Dodick, MD

Mayo Clinic

More Information

Responsible Party:	Boston Scientific ( Pam Phongpharnich, Sr. Clinical Research Associate )
Study ID Numbers:	CR-B-003
Study First Received:	September 13, 2005
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00205894
Health Authority:	United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:

Headache
Chronic headache
Migraine
Pain
Cluster headache

Study placed in the following topic categories:

Cluster Headache
Signs and Symptoms
Migraine Disorders
Headache
Central Nervous System Diseases

Neurologic Manifestations
Pain
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009