Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: Results from a randomized, multicenter, double-blinded, controlled study

Abstract

Clinical trials.gov (NCT00615342).

Diagnosis, pathophysiology and management of chronic migraine: a proposal of the Belgian Headache Society

“…Finally, in Silberstein et al's [81] ONS trial on 157 patients with CM, no difference was found between sham and verum at the end of the 3-month treatment period for the primary outcome measure: percentage of patients who had C50 % reduction in mean daily headache intensity. There was, however, a significant difference in favour of ONS in the percentage of patients with a 30 % reduction in mean number of headache days (p \ 0.05) and a decrease of the MIDAS score (p \ 0.01).…”

“…3 months each) RCT were performed in CM [79][80][81]. The ONSTIM study (n = 66 patients, [80]) showed a reduction of C50 % in headache frequency or a decrease of three points on the intensity scale in 39 % of patients treated with active ONS during 12 weeks, compared to no improvement in the ''non-effectively'' stimulated or medically treated groups.…”

Interfacing with the nervous system: a review of current bioelectric technologies

“…From percutaneous cranial nerve stimulation to treat chronic [35,36,75,136,142] and episodic [107,125] migraines and neuralgia, to epidural placement of leads in the dorsal root ganglion (DRG) for treatment of neuropathic pain [68], and to direct sacral anterior root stimulation to enhance bowel function post-spinal injury [117], electrical stimulation of nerves or nerve roots has been demonstrated to be a safe and efficacious clinical intervention. Although long-term repercussions of implantable neurostimulators have yet to be fully elucidated, the major shortcomings of implantable devices arise from the fibrotic foreign body response that develops following implantation, particularly following implantation within the peripheral or central nervous system [10].…”

“…All three of their devices, the external trigeminal nerve stimulator [107], supraorbital transcutaneous nerve stimulator [35,75], and the external occipital nerve stimulator [142], have been demonstrated to be efficacious in decreasing migraine intensity, frequency, and associated pain medication consumption [36]. The electrical stimulation from these devices is thought to block ascending impulses of trigeminal nerve nociceptors and may decrease metabolic activity of the orbitofrontal and anterior cingulate cortices, hence reducing pain signal generation and subsequent pain sensation [74,125].…”

“…At present, a variety of implantable nerve stimulators have been clinically employed and demonstrated to be efficacious in alleviating numerous pathologies. Several implantable devices are already in routine use, including hypoglossal nerve stimulation in patients with severe obstructive sleep apnea [76,137]; chronic spinal cord stimulation in patients with severe neuropathic pain [153,160]; direct electrical stimulation of peripheral nerves in patients with bladder, bowel, and sexual dysfunction [30,40]; and even transcutaneous stimulation of the trigeminal nerve in migraine patients [35,36,75,107,125,136,142]. Deep brain stimulation (DBS) is arguably the most successful example of a bioelectric technology that has transitioned into the clinical realm to treat a variety of neurological disorders with an incredible degree of efficacy [59,108].…”