Occipital Nerve Stimulation to Treat Chronic Headaches
CompletedPhase 1, Phase 2NCT00205894
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Multicenter Feasibility Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches
- Conditions
- Interventions
- Device: bion microstimulator
- Sponsor
- Boston Scientific Corporation
- Start date
- 2004-01
- Primary completion
- 2006-10
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00205894