Back to resultsOccipital Nerve Stimulation to Treat Chronic Headaches
Primary Purpose
Headache Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
bion microstimulator
Sponsored by
About this trial
This is an interventional treatment trial for Headache Disorders focused on measuring Headache, Chronic headache, Migraine, Pain, Cluster headache
Eligibility 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.
Sites / Locations
- Mayo Clinic
- Michigan Head Pain & Neurological Institute
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00205894
First Posted
September 13, 2005
Last Updated
September 4, 2008
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00205894
Brief Title
Occipital Nerve Stimulation to Treat Chronic Headaches
Official Title
Multicenter Feasibility Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache Disorders
Keywords
Headache, Chronic headache, Migraine, Pain, Cluster headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
bion microstimulator
Primary Outcome Measure Information:
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Dodick, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Michigan Head Pain & Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19461827
Citation
Trentman TL, Rosenfeld DM, Vargas BB, Schwedt TJ, Zimmerman RS, Dodick DW. Greater occipital nerve stimulation via the Bion microstimulator: implantation technique and stimulation parameters. Clinical trial: NCT00205894. Pain Physician. 2009 May-Jun;12(3):621-8.
Results Reference
derived
Learn more about this trial
Occipital Nerve Stimulation to Treat Chronic Headaches
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