Bion for Occipital Nerve Stimulation
Chronic Headaches
About this trial
This is an interventional treatment trial for Chronic Headaches focused on measuring Chronic headaches, greater occipital nerve stimulation
Eligibility Criteria
Inclusion Criteria: Be diagnosed with chronic migraine or primary chronic daily headache Have headaches characterized by pain Be 18 years of age or older; Be willing and able to follow all study-related procedures during course of study; Have exhibited refractoriness to two acute medication regimens and two prophylactic medications from two separate preventive classes. Exclusion Criteria: Have received a botulinum toxin (botox) injection for treatment of headache within the last 90 days; Have previously undergone destructive ganglionectomy 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 during this study in another 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; Demonstrate significant psychological signs, substance abuse symptoms, or behavioral problems on examination and/or history that, in the investigator's judgment, render them inappropriate for the study; Currently require, or be likely to require, diathermy; Have other medical conditions that the investigator believes would confound the study.
Sites / Locations
- University College London - Institute of Neurology
Arms of the Study
Arm 1
Experimental
Active Therapy
Occipital nerve stimulation (ONS) therapy delivered to a subject implanted with a bion ONS device