Greater occipital nerve stimulation via the Bion microstimulator: implantation technique and stimulation parameters. Clinical trial: NCT00205894.
BACKGROUND
Millions of patients suffer from medically refractory and disabling primary headache disorders. This problem has led to a search for new and innovative treatment modalities, including neuromodulation of the occipital nerves.


OBJECTIVE
The primary aim of this study is to describe an implantation technique for the Bion microstimulator and document stimulation parameters and stimulation maps after Bion placement adjacent to the greater occipital nerve. The secondary aim is to document outcome measures one year post-implant.


METHODS
Prospective, observational feasibility study.


METHODS
Nine patients with medically refractory primary headache disorders participated in this study. Approximately 6 months after Bion insertion, stimulation parameters and maps were documented for all patients. At one year, outcome measures were collected including the Migraine Disability Assessment Score.


RESULTS
At 6 months, the mean perception threshold was 0.47 mA, while the mean discomfort threshold was 6.8 mA (stimulation range 0.47-6.8 mA). The mean paresthesia threshold was 1.64 mA and the mean usage range was 16.0. There were no major complications reported such as device migration, infection, or erosion. One patient stopped using her Bion before the 12-month follow-up visit. At one year, 7 of the 8 patients were judged as having obtained fair or better results in terms of reduction of disability; 5 patients had greater than a 90% reduction in disability.


CONCLUSIONS
Small, heterogeneous patient population without control group. Not blinded or randomized.


CONCLUSIONS
The Bion can be successfully inserted adjacent to the greater occipital nerve in an effort to treat refractory primary headache disorders. This microstimulator may provide effective occipital stimulation and headache control while minimizing the risks associated with percutaneous or paddle leads implanted subcutaneously in the occipital region.
Trentman
Terrence L
TL
Department of Anesthesiology, Mayo Clinic Arizona, Scottsdale, AZ 85054, USA. trentman.terrence@mayo.edu
Rosenfeld
David M
DM
Vargas
Bert B
BB
Schwedt
Todd J
TJ
Zimmerman
Richard S
RS
Dodick
David W
DW
D000328:Adult; D000368:Aged; D003027:Cluster Headache / Q000503:physiopathology / Q000628:therapy; D004599:Electric Stimulation Therapy / Q000379:methods* / Q000706:statistics & numerical data*; D004567:Electrodes, Implanted; D004582:Electronics, Medical / Q000295:instrumentation / Q000379:methods; D004868:Equipment Failure; D005260:Female; D020773:Headache Disorders / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000503:physiopathology / Q000628:therapy; D019635:Neurosurgical Procedures / Q000295:instrumentation / Q000379:methods; D017063:Outcome Assessment, Health Care / Q000379:methods; D010147:Pain Measurement / Q000379:methods; D017060:Patient Satisfaction; D010525:Peripheral Nerves / Q000033:anatomy & histology / Q000502:physiology / Q000601:surgery*; D011183:Postoperative Complications / Q000209:etiology / Q000503:physiopathology; D011446:Prospective Studies; D016896:Treatment Outcome