Non-invasive vagus nerve stimulation (nVNS) as symptomatic treatment of migraine in young patients: a preliminary safety study

Grazzi, Licia; Egeo, Gabriella; Liebler, Eric; Padovan, Anna Maria; Barbanti, Piero

doi:10.1007/s10072-017-2942-5

Cited by 40 publications

(36 citation statements)

References 13 publications

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“…Our findings add to pre-existing evidence for the potential therapeutic value and safety of the preventive and acute use of nVNS as an adjunctive to prophylactic and abortive drugs in EM patients. We observed comparable responsiveness for head pain severity and frequency [9][10][11][12][13][14][15][16][17][18][19] outcome parameter of the PRESTO study and found a higher rate of pain-freedom and pain-relief attacks as well as a higher rate of severity reduction in migraine patients compared to sham stimulation [17]. This meaningful improvement was accompanied by a considerable rescue medication decrease [18].…”

Section: Brief Summary Of Study Findings and Comparison With Availablmentioning

confidence: 63%

“…However, preventive and abortive pharmacological/behavioral interventions overlap in both migraine subtypes and failed to achieve favorable response in a considerable proportion of migraineurs [6][7][8]. Thus, cervical non-invasive vagus stimulation (nVNS) has been approved to represent a reasonable and safe adjunctive treatment option for prevention and abortive migraine therapy [9][10][11][12][13][14][15][16]. In two RCT trials, the EVENT study (chronic migraine prevention with non-invasive vagus nerve stimulation) and PRESTO study (prospective study of nVNS for the acute treatment of migraine) and several prospective observational cohort studies, nVNS demonstrated the capability to effectively act as adjunctive prophylaxis and rescue intervention in episodic and chronic migraine as well as in associated mood and sleep disturbance [10][11][12][16][17][18][19].…”

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confidence: 99%

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Saliva molecular inflammatory profiling in female migraine patients responsive to adjunctive cervical non-invasive vagus nerve stimulation: the MOXY Study

et al. 2019

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Background: Rising evidence indicate that oxytocin and IL-1β impact trigemino-nociceptive signaling. Current perspectives on migraine physiopathology emphasize a cytokine bias towards a pro-inflammatory status. The antinociceptive impact of oxytocin has been reported in preclinical and human trials. Cervical non-invasive vagus nerve stimulation (nVNS) emerges as an add-on treatment for the preventive and abortive use in migraine. Less is known about its potential to modulate saliva inflammatory signaling in migraine patients. The rationale was to perform inter-ictal saliva measures of oxytocin and IL-1ß along with headache assessment in migraine patients with 10 weeks adjunctive nVNS compared to healthy controls.Methods: 12 migraineurs and 12 suitably matched healthy control were studied with inter-ictal saliva assay of proand anti-neuroinflammatory cytokines using enzyme-linked immuno assay techniques along with assessment of headache severity/frequency and associated functional capacity at baseline and after 10 weeks adjunctive cervical nVNS.Results: nVNS significantly reduced headache severity (VAS), frequency (headache days and total number of attacks) and significantly improved sleep quality compared to baseline (p < 0.01). Inter-ictal saliva oxytocin and IL-1β were significantly elevated pre-as well as post-nVNS compared to healthy controls (p < 0.01) and similarly showed changes that may reflect the observed clinical effects. Conclusions:Our results add to accumulating evidence for a therapeutic efficacy of adjunct cervical non-invasive vagus nerve stimulation in migraine patients. This study failed to provide an evidence-derived conclusion addressed to the predictive value and usefulness of saliva assays due to its uncontrolled study design. However, saliva screening of mediators associated with trigemino-nociceptive traffic represents a novel approach, thus deserve future targeted headache research.

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Section: Brief Summary Of Study Findings and Comparison With Availablmentioning

confidence: 63%

mentioning

confidence: 99%

Saliva molecular inflammatory profiling in female migraine patients responsive to adjunctive cervical non-invasive vagus nerve stimulation: the MOXY Study

et al. 2019

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“…A preliminary open-label single-arm safety study in nine adolescents (13-18 years old) EM without aura patients revealed that 46.8% of their treated migraine attacks showed a beneficial result. No device-related AEs were observed [34]. For menstrual/menstrually related migraine patients (n = 56), an open-label non-invasive VNS study as mini-prophylaxis revealed that 39% of the subjects showed 50% or more reduction in headache days.…”

Section: Open-label Studies Of Transcutaneous Vns (The Gammacore® Devmentioning

confidence: 93%

Therapeutic strategies that act on the peripheral nervous system in primary headache disorders

Tajti

Delia

Nyári

et al. 2019

Expert Review of Neurotherapeutics

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Introduction: Acute and preventive treatment of primary headache disorders is not completely resolved with regard to efficacy, safety, and tolerability. Hence, peripheral and central neuromodulation can provide therapeutic alternatives in drug-resistant cases. Peripheral targets of neuromodulation include invasive and non-invasive neurostimulation and electrical and chemical nerve and ganglion blockades. Areas covered: A PubMed search of papers published from January 2012 to October 2018 was conducted. The goal of this review was to analyze the efficacy and safety of invasive (implantable) peripheral neurostimulation methods (the occipital nerve, the cervical branch of vagal nerve, the sphenopalatine ganglion) and non-invasive (transcutaneous) peripheral neurostimulation methods (the occipital nerve, the supraorbital nerve, and the cervical and auricular branches of the vagal nerve), based on the results of published clinical trials and case series. Acting also on the peripheral nervous system, peripheral nerve (i.e. greater occipital nerve) and ganglion (i.e. sphenopalatine ganglion) blockades, botulinum neurotoxin type A-hemagglutinin complex therapies, and calcitonin generelated peptide-related monoclonal antibody treatments in this patient population are also discussed. Expert opinion: This review summarizes the latest results on the therapeutic strategies acting on the periphery in primary headache disorders. These therapeutic options are minimally invasive or noninvasive, efficacious, safe, and well tolerated. ARTICLE HISTORY

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“…Interestingly, in 47% of all nVNS-treated attacks, adjunctive rescue medication was not required and 53% of all attacks required rescue medication. A pain-free state was observed after 1 h of treatment in 40% (19/47) and pain relief was observed in 6% (3/47) 16. Given these facts, nVNS deserves clinical attention as a considerable and safe alternative in migraine subtypes with impaired therapy options like menstrual-related migraine or migraine in young adolescents.…”

Section: Cervical Noninvasive Vns and Primary Headache Disordersmentioning

confidence: 99%

Spotlight on cervical vagus nerve stimulation for the treatment of primary headache disorders: a review

Lendvai

Maier

Scheele

et al. 2018

JPR

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ObjectivesCervical noninvasive vagus nerve stimulation (nVNS) emerged as an adjunctive neuromodulation approach for primary headache disorders with limited responsiveness to pharmacologic and behavioral treatment. This narrative review evaluates the safety and efficacy of invasive and noninvasive peripheral nerve stimulation of the cervical branch of the vagal nerve (afferent properties) for primary headache disorders (episodic/chronic migraine [EM/CM] and cluster headache [ECH/CCH]) and provides a brief summary of the preclinical data on the possible mechanism of action of cervical vagus nerve stimulation (VNS) and trigemino-nociceptive head pain transmission.Materials and methodsA systematic search of published data was performed in PubMed for randomized controlled trials (RCTs) and prospective cohort clinical studies assessing the efficacy/safety and cost-effectiveness of cervical VNS in primary headache disorders and related preclinical studies.ResultsThree RCTs were identified for ECH/CCH (ACT-1, ACT-2 and PREVA), one RCT for migraine (EVENT) and several prospective cohort studies and retrospective analyses for both headache disorders. In ACT-1, a significantly higher response rate, a higher pain-free rate and a decrease in mean attack duration were found in nVNS-treated ECH/CCH patients compared to sham stimulation. ACT-2 confirmed these findings (e.g., significantly higher pain-free attacks, pain severity decline and increased responder-rate [defined as ≥50% reduction]). The PREVA study demonstrated the superiority of adjunctive nVNS to standard care alone and observed a significantly higher attack reduction (p=0.02) and responder rate (defined as ≥50% reduction). For CM, the EVENT study assessed a significantly higher frequency of decline in the open-label phase. Mostly transient mild/moderate adverse events were recorded, and no severe device-related adverse events occurred.ConclusionCervical nVNS represents a novel, safe and efficient adjunctive treatment option for primary headache disorders. In particular, preliminary observations suggest enhanced nVNS responsiveness in favor of episodic subtypes (EM and ECH). However, preclinical studies are urgently warranted to dissect the mechanism of action.

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Non-invasive vagus nerve stimulation (nVNS) as symptomatic treatment of migraine in young patients: a preliminary safety study

Cited by 40 publications

References 13 publications

Saliva molecular inflammatory profiling in female migraine patients responsive to adjunctive cervical non-invasive vagus nerve stimulation: the MOXY Study

Saliva molecular inflammatory profiling in female migraine patients responsive to adjunctive cervical non-invasive vagus nerve stimulation: the MOXY Study

Therapeutic strategies that act on the peripheral nervous system in primary headache disorders

Spotlight on cervical vagus nerve stimulation for the treatment of primary headache disorders: a review

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