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Non-invasive vagus nerve stimulation for PREVention and Acute treatment of chronic cluster headache (PREVA): A randomised controlled study.

ABSTRACT: Chronic cluster headache (CH) is a debilitating disorder for which few well-controlled studies demon.strate effectiveness of available therapies. Non-invasive vagus nerve stimulation (nVNS) was examined as adjunctive prophylactic treatment of chronic CH.PREVA was a prospective, open-label, randomised study that compared adjunctive prophylactic nVNS (n?=?48) with standard of care (SoC) alone (control (n?=?49)). A two-week baseline phase was followed by a four-week randomised phase (SoC plus nVNS vs control) and a four-week extension phase (SoC plus nVNS). The primary end point was the reduction in the mean number of CH attacks per week. Response rate, abortive medication use and safety/tolerability were also assessed.During the randomised phase, individuals in the intent-to-treat population treated with SoC plus nVNS (n?=?45) had a significantly greater reduction in the number of attacks per week vs controls (n?=?48) (-5.9 vs -2.1, respectively) for a mean therapeutic gain of 3.9 fewer attacks per week (95% CI: 0.5, 7.2; p?=?0.02). Higher ?50% response rates were also observed with SoC plus nVNS (40% (18/45)) vs controls (8.3% (4/48); p?

SUBMITTER: Gaul C

PROVIDER: S-EPMC4853813 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Non-invasive vagus nerve stimulation for PREVention and Acute treatment of chronic cluster headache (PREVA): A randomised controlled study.

Gaul Charly C Diener Hans-Christoph HC Silver Nicholas N Magis Delphine D Reuter Uwe U Andersson Annelie A Liebler Eric J EJ Straube Andreas A

Cephalalgia : an international journal of headache 20150921 6

<h4>Background</h4>Chronic cluster headache (CH) is a debilitating disorder for which few well-controlled studies demon.strate effectiveness of available therapies. Non-invasive vagus nerve stimulation (nVNS) was examined as adjunctive prophylactic treatment of chronic CH.<h4>Methods</h4>PREVA was a prospective, open-label, randomised study that compared adjunctive prophylactic nVNS (n = 48) with standard of care (SoC) alone (control (n = 49)). A two-week baseline phase was followed by a four-we ...[more]

PMID: 26391457

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Project description:Cluster headache (CH) is a debilitating condition that is generally associated with substantial health care costs. Few therapies are approved for abortive or prophylactic treatment. Results from the prospective, randomised, open-label PREVA study suggested that adjunctive treatment with a novel non-invasive vagus nerve stimulation (nVNS) device led to decreased attack frequency and abortive medication use in patients with chronic CH (cCH). Herein, we evaluate whether nVNS is cost-effective compared with the current standard of care (SoC) for cCH.A pharmacoeconomic model from the German statutory health insurance perspective was developed to estimate the 1-year cost-effectiveness of nVNS?+?SoC (versus SoC alone) using data from PREVA. Short-term treatment response data were taken from the clinical trial; longer-term response was modelled under scenarios of response maintenance, constant rate of response loss, and diminishing rate of response loss. Health-related quality of life was estimated by modelling EQ-5D™ data from PREVA; benefits were defined as quality-adjusted life-years (QALY). Abortive medication use data from PREVA, along with costs for the nVNS device and abortive therapies (i.e. intranasal zolmitriptan, subcutaneous sumatriptan, and inhaled oxygen), were used to assess health care costs in the German setting.The analysis resulted in mean expected yearly costs of €7096.69 for nVNS?+?SoC and €7511.35 for SoC alone and mean QALY of 0.607 for nVNS?+?SoC and 0.522 for SoC alone, suggesting that nVNS generates greater health benefits for lower overall cost. Abortive medication costs were 23 % lower with nVNS?+?SoC than with SoC alone. In the alternative scenarios (i.e. constant rate of response loss and diminishing rate of response loss), nVNS?+?SoC was more effective and cost saving than SoC alone.In all scenarios modelled from a German perspective, nVNS was cost-effective compared with current SoC, which suggests that adjunctive nVNS therapy provides economic benefits in the treatment of cCH. Notably, the current analysis included only costs associated with abortive treatments. Treatment with nVNS will likely promote further economic benefit when other potential sources of cost savings (e.g. reduced frequency of clinic visits) are considered.Clinicaltrials.gov identifier NCT01701245 , 03OCT2012.

Project description:To evaluate non-invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment.Many patients with CH experience excruciating attacks at a frequency that is not sufficiently addressed by current symptomatic treatments.One hundred fifty subjects were enrolled and randomized (1:1) to receive nVNS or sham treatment for ?1 month during a double-blind phase; completers could enter a 3-month nVNS open-label phase. The primary end point was response rate, defined as the proportion of subjects who achieved pain relief (pain intensity of 0 or 1) at 15 minutes after treatment initiation for the first CH attack without rescue medication use through 60 minutes. Secondary end points included the sustained response rate (15-60 minutes). Subanalyses of episodic cluster headache (eCH) and chronic cluster headache (cCH) cohorts were prespecified.The intent-to-treat population comprised 133 subjects: 60 nVNS-treated (eCH, n?=?38; cCH, n?=?22) and 73 sham-treated (eCH, n?=?47; cCH, n?=?26). A response was achieved in 26.7% of nVNS-treated subjects and 15.1% of sham-treated subjects (P?=?.1). Response rates were significantly higher with nVNS than with sham for the eCH cohort (nVNS, 34.2%; sham, 10.6%; P?=?.008) but not the cCH cohort (nVNS, 13.6%; sham, 23.1%; P = .48). Sustained response rates were significantly higher with nVNS for the eCH cohort (P?=?.008) and total population (P?=?.04). Adverse device effects (ADEs) were reported by 35/150 (nVNS, 11; sham, 24) subjects in the double-blind phase and 18/128 subjects in the open-label phase. No serious ADEs occurred.In one of the largest randomized sham-controlled studies for acute CH treatment, the response rate was not significantly different (vs sham) for the total population; nVNS provided significant, clinically meaningful, rapid, and sustained benefits for eCH but not for cCH, which affected results in the total population. This safe and well-tolerated treatment represents a novel and promising option for eCH. ClinicalTrials.gov identifier: NCT01792817.

Project description:BackgroundNon-invasive stimulation of the vagus nerve has been proposed as a new neuromodulation therapy to treat primary headache disorders, as the vagus nerve is hypothesized to modulate the headache pain pathways in the brain. Vagus nerve stimulation can be performed by placing an electrode on the ear to stimulate the tragus nerve, which contains about 1% of the vagus fibers. Non-invasive vagus nerve stimulation (nVNS) conventionally refers to stimulation of the cervical branch of the vagus nerve, which is made up entirely of vagal nerve fibers. While used interchangeably, most of the research to date has been performed with nVNS or an implanted vagus nerve stimulation device. However, the exact mechanism of action of nVNS remains hypothetical and no clear overview of the effectiveness of nVNS in primary headache disorders is available.MethodsIn the present study, the clinical trials that investigated the effectiveness, tolerability and safety of nVNS in primary headache disorders were systematically reviewed. The second part of this study reviewed the central connections of the vagus nerve. Papers on the clinical use of nVNS and the anatomical investigations were included based on predefined criteria, evaluated, and results were reported in a narrative way.ResultsThe first part of this review shows that nVNS in primary headache disorders is moderately effective, safe and well-tolerated. Regarding the anatomical review, it was reported that fibers from the vagus nerve intertwine with fibers from the trigeminal, facial, glossopharyngeal and hypoglossal nerves, mostly in the trigeminal spinal tract. Second, the four nuclei of the vagus nerve (nuclei of the solitary tract, nucleus ambiguus, spinal nucleus of the trigeminal nerve and dorsal motor nucleus (DMX)) show extensive interconnections. Third, the efferents from the vagal nuclei that receive sensory and visceral input (i.e. nuclei of the solitary tract and spinal nucleus of the trigeminal nerve) mainly course towards the main parts of the neural pain matrix directly or indirectly via other vagal nuclei.ConclusionThe moderate effectiveness of nVNS in treating primary headache disorders can possibly be linked to the connections between the trigeminal and vagal systems as described in animals.

Project description:Background:Cluster headache (CH) is considered to be a catastrophic disease presenting the most severe human pain condition. Available pharmacological treatments are hampered by unwanted side effects, and there is an urgent need for non-pharmacological treatment alternatives. We present a novel therapeutic approach for chronic CH, having evolved from an episodic CH, using a non-invasive percutaneous bioelectric current stimulation (PBCS), which generates static electric fields in the range of the naturally occurring electric potentials. Patients and Methods:This study employed a retrospective data analysis of 20 cases of chronic cluster headache (CCH) patients, four of those having had cluster-related surgery (SPG, ONS). All patients were treated with PBCS between 2014 and 2018. Data of these patients were analyzed with respect to frequency of CH attacks and triptan application and followed up for one (20 cases) or two (12 cases) years. Results:Four weeks after the first PBCS treatment, cluster headache attacks were reduced from 2.8 to 1.7 per day and triptan application decreased from 2.5 to 1.5 times/day. Six non-responders, 4 of which had pre-CH surgery, did not show any reaction to PBCS, while 14 responders improved within 4 weeks from 2.2 to 0.7 attacks/day and 2.0 to 0.4 triptan applications/day. A 50% or greater reduction of attack frequency was observed in 10 patients after 4 weeks and in 11 patients after 12 weeks. One year after the first treatment, 13/20 patients experienced a reduction of attack frequency of 50% or more, while remarkably 10 patients were completely free of attack. After 2 years, 8 of 12 patients experienced a reduction of attack frequency of 50% or more and 7 of those were completely symptom-free. No serious adverse effects were observed. Conclusion:PBCS is a promising transformative treatment approach for CCH patients. Drug consumption was reduced significantly, and the CCH may revert back to an episodic cluster headache with increasingly long times of remission. Responders can be clearly differentiated from non-responders. The data support the need for randomized controlled trials.

Dataset Information

Non-invasive vagus nerve stimulation for PREVention and Acute treatment of chronic cluster headache (PREVA): A randomised controlled study.

Publications

Non-invasive vagus nerve stimulation for PREVention and Acute treatment of chronic cluster headache (PREVA): A randomised controlled study.

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