Multicenter Feasibility Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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 Outcomes
No secondary outcomes reported