Occipital nerve stimulation for chronic migraine: A randomized trial on subthreshold stimulation

Background In many patients suffering from primary headaches, the available pharmacological and behavioural treatments are not satisfactory. This is a review of (minimally) invasive interventions targeting pericranial nerves that could be effective in refractory patients. Methods The interventions we will cover have in common pericranial nerves as targets, but are distinct according to their rationale, modality and invasiveness. They range from nerve blocks/infiltrations to the percutaneous implantation of neurostimulators and surgical decompression procedures. We have critically analysed the published data (PubMed) on their effectiveness and tolerability. Results and conclusions There is clear evidence for a preventative effect of suboccipital injections of local anaesthetics and/or steroids in cluster headache, while evidence for such an effect is weak in migraine. Percutaneous occipital nerve stimulation (ONS) provides significant long-term relief in more than half of drug-resistant chronic cluster headache patients, but no sham-controlled trial has tested this. The evidence that ONS has lasting beneficial effects in chronic migraine is at best equivocal. Suboccipital infiltrations are quasi-devoid of side effects, while ONS is endowed with numerous, though reversible, adverse events. Claims that surgical decompression of multiple pericranial nerves is effective in migraine are not substantiated by large, rigorous, randomized and sham-controlled trials.

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“…The suprathreshold stimulation was found to be more effective than the subthreshold one, but the latter was also superior to no stimulation (42).…”

Section: Migrainementioning

confidence: 84%

Invasive pericranial nerve interventions

Ambrosini

Schoenen

2016

Cephalalgia

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“…However, use of this technology is limited given the risk of skin burning, and the inability to use TENS through bandages or clothing. Sub-threshold neuromodulation therapy, whether used transcutaneously or invasively, has already shown its potential in modulating a variety of nerves: the occipital nerve for treating migraines [14], sacral nerve for treating bowel incontinence [3] and vagal sympathetic complex to treat heart failure [15]. Correspondingly, the ability to modulate nerve activity without invasive procedures/skin contact would have significant advantages for those capable of benefiting from traditional neurostimulation therapies.…”

Section: Resultsmentioning

confidence: 99%

Rectification of RF Fields in Load Dependent Coupled Systems: Application to Non-Invasive Electroceuticals

Koneru¹,

Westgate²,

McLeod³

2016

JBiSE

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Electroceuticals are medical devices that employ electric signals to alter the activity of specific nerve fibers to achieve therapeutic effects. The rapid growth of RF microelectronics has resulted in the development of very small, portable, and inexpensive shortwave and microwave radio frequency (RF) amplifiers, raising the possibility of utilizing these new RF technologies to develop non-contact electroceutical devices. However, the bio-electromagnetics literature suggests that beyond 10 MHz, RF fields cannot influence biological tissue, beyond simple heating, because effective demodulation mechanisms at these frequencies do not exist in the body. However, RF amplifiers operating at or near saturation have non-linear interactions with complex loads, and if body tissue creates a complex loading condition, the opportunity exists for the coupled system to produce non-linear effects, that is, the equivalent of demodulation may occur. Correspondingly, exposure of tissue to pulsed RF energy could result in the creation of low frequency demodulation components capable of influencing tissue activity. Here, we develop a one-dimensional, numerical simulation to investigate the complex loading conditions under which such demodulation could arise. Applying these results in a physical prototype device, we show that up to7.5% demodulation can be obtained for a 40 MHz RF field pulsed at 1 KHz. Implications for this research include the possibility of developing wearable, electromagnetic electroceutical devices.

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“…Patients were blinded to the intervention between the subthreshold and sham stimulations phase. The mean VAS was 8.45 ± 0.99 in the sham stimulation group, 5.65 ± 2.11 in the subthreshold stimulation group, and 1.98 ± 1.56 in the effective stimulation group at a 7‐day follow‐up ( P < 0.01). In the RCOT by Serra et al., 29 patients cycled through treatment and control groups, and there was a significant difference in pain severity between these 2 groups at the 1‐year follow‐up…”

Section: Resultsmentioning

confidence: 95%

Occipital Nerve Stimulation for Migraine: A Systematic Review

et al. 2015

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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.

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Occipital nerve stimulation for chronic migraine: A randomized trial on subthreshold stimulation

Abstract: Paresthesia is not required to achieve pain reduction but suprathreshold stimulation yields better results, underlining the significance of stimulation parameter customization.

Cited by 40 publications

References 13 publications

Invasive pericranial nerve interventions

Invasive pericranial nerve interventions

Rectification of RF Fields in Load Dependent Coupled Systems: Application to Non-Invasive Electroceuticals

Occipital Nerve Stimulation for Migraine: A Systematic Review

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