Occipital Nerve Stimulation for Migraine: A Systematic Review

Abstract

Patients who suffer from migraines often report impaired quality of life. Occipital nerve stimulation (ONS) is a novel treatment modality for migraines, although few systematic reviews have evaluated whether this therapy is efficacious. The objective of this study was to evaluate the clinical efficacy and safety of ONS for treating migraine through a literature review. We performed a literature search to identify studies that investigated ONS for migraine treatment. Evidence levels of these studies were assessed by recommendations set by the University of Oxford Centre for Evidence-Based Medicine. Five randomized controlled trials, 4 retrospective studies, and one prospective study met the inclusion criteria. Results from the retrospective studies and case series indicated that ONS significantly reduced the pain intensity and the number of days with headache in patients with migraine. However, the evidence of ONS efficacy established by randomized controlled trials was limited. Improvement in the migraine disability assessment (MIDAS) score was more dramatic than improvement in the SF-36 score at follow-up. The mean complication incidence of ONS was 66% for the reviewed studies. Future clinical studies should optimize and standardize the ONS intervention process and identify the relationship among the surgical process, efficacy, and complications resulting from the procedure.

Investigating Complications Associated With Occipital Nerve Stimulation: A MAUDE Study

“…As in this study, lead migration is generally reported as the most common device‐related complication, comprising 16.7% of total complications reported to the MAUDE data base over the past ten years . Reported migration rates have ranged from 0% to 100%, though it is reported to affect 21% of all patients .…”

“…Even though insufficient evidence exists for proper characterization of the ONS safety profile, comparing the available evidence with our MAUDE findings will give clues of the accuracy of our current understanding . Using our assumption that there were 11,000 implants in the past ten years, the MAUDE reports would suggest an 11.2% incidence of complication.…”

“…This rate is lower than most rates found in the literature, which supports the idea that our estimation of total ONS implants is too high and that MAUDE may be unable to accurately represent complication rates. The mean incidence of complications found in studies is 66%, though these rates are highly variable . Randomized control trials (RCT) reported serious adverse events three months following treatment in 1% and 6% of patients, while smaller case series' have found rates of serious complications to be up to 20% with varied follow‐up .…”

“…Reported migration rates have ranged from 0% to 100%, though it is reported to affect 21% of all patients . Rates of migration also increase with longer durations of follow‐up, likely due to incremental movement over time making migrations more likely to occur . The incidence of infection ranged from 4% to 30%, though exact rates are difficult to determine due to varied methods of classification .…”

“…Occipital Nerve stimulation (ONS) is a therapy for the treatment of chronic refractory headaches, migraines, and craniofacial pain (1)(2)(3)(4)(5)(6). Unfortunately, ONS is not FDA approved for any of these indications.…”