Occipital Nerve Stimulation to Treat Chronic Headaches

Headache Disorders Clinical Trial

Official title:

Multicenter Feasibility Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205894
• Other study ID #: CR-B-003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: September 4, 2008
• Start date: January 2004
• Est. completion date: September 2007

Study information

• Verified date: August 2008
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Headache Disorders

Intervention

Device:
• bion microstimulator

Locations

Country	Name	City	State
United States	Michigan Head Pain & Neurological Institute	Ann Arbor	Michigan
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.