Clinical trial NCT00205894: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Headache Disorders
Keywords: Headache
Chronic headache
Migraine
Pain
Cluster headache
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
measure: 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 outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Ann Arbor
country: United States
facility: Michigan Head Pain & Neurological Institute
state: Michigan
Study officials:
affiliation: Mayo Clinic
name: David Dodick, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.