Medical Devices: Evidence and Research (Nov 2013)
Clinical utility of implantable neurostimulation devices in the treatment of chronic migraine
Abstract
John A Freeman, Terrance L Trentman Department of Anesthesiology, Division of Pain Medicine, Mayo Clinic Arizona, Phoenix, AZ, USA Abstract: Chronic migraine is a disabling disorder that is costly to individuals and society. Occipital nerve stimulation has been used to treat refractory cases of primary headache disorders including drug-resistant chronic cluster headaches and chronic migraine. The Food and Drug Administration (FDA) off-labeled application of equipment used for peripheral nerve (occipital) stimulation is borrowed from FDA-labeled spinal cord stimulation. Manufacturer-sponsored randomized trials include a feasibility study (ONSTIM-Medtronic) and a safety and efficacy study (St Jude). A non-industry sponsored prospective, randomized crossover study by Serra and Marchiotretto suggests improved quality of life and a significant reduction in medication use. Though preliminary studies suggest occipital nerve stimulation is safe and efficacious in treating chronic migraine headache, complication rates, including lead migration, lead fracture, and surgical site infections remain high. Further studies are needed to demonstrate long-term outcomes, while improved surgical techniques and site-specific equipment are needed to minimize complications. Keywords: headache, occipital nerve stimulation, peripheral nerve stimulation, neuromodulation, electrical stimulation therapy