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. OBJECTIVES: 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. DESIGN: 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. LIMITATIONS: Small, heterogeneous patient population without control group. Not blinded or randomized. CONCLUSION: 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.
RCT Entities:
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. OBJECTIVES: 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. DESIGN: 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. LIMITATIONS: Small, heterogeneous patient population without control group. Not blinded or randomized. CONCLUSION: 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.
Authors: Rafael Caiado Vencio; Paulo Eduardo Albuquerque Zito Raffa; André Costa Corral Ponce; Bruno Pricoli Malamud; César Cozar Pacheco; Paulo Roberto Franceschini; Roger Thomaz Rotta Medeiros; Paulo Henrique Pires de Aguiar Journal: Surg Neurol Int Date: 2021-04-26