Trial reportThe journal of headache and pain2017
Effects of non-invasive vagus nerve stimulation on attack frequency over time and expanded response rates in patients with chronic cluster headache: a post hoc analysis of the randomised, controlled PREVA study.
Trial report in The journal of headache and pain, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.
- Noninvasive Vagus Nerve Stimulation for Cluster Headache and Migraine: A Health Technology Assessment.Ontario health technology assessment series · 2025Pooled it
- Transcutaneous Cervical Vagus Nerve Stimulation Modulates Prefrontal Cortex Activity During Opioid Withdrawal in Individuals With Opioid Use Disorder.Neuromodulation : journal of the International Neuromodulation Society · 2025Trial
- Non-Invasive Neuromodulation in the Treatment of Headache.Current neurology and neuroscience reports · 2025Review
- Non-Invasive Vagus Nerve Stimulation in Cluster Headache: A Clinical Practice Guideline.Pain practice : the official journal of World Institute of Pain · 2025Review
- Acute and long-term effects of COVID-19 on brain and mental health: A narrative review.Brain, behavior, and immunity · 2025Review
- Effects of Non-Invasive Neuromodulation of the Vagus Nerve for the Management of Cluster Headache: A Systematic Review.Journal of clinical medicine · 2023Review
- An open-label observational study and meta-analysis of non-invasive vagus nerve stimulation in medically refractory chronic cluster headache.Frontiers in neurology · 2023Article
- Noninvasive Vagal Nerve Stimulation for Opioid Use Disorder.Annals of depression and anxiety · 2023Article
- Devices for Episodic Migraine: Past, Present, and Future.Current pain and headache reports · 2022Review
- gammaCore for Cluster Headaches: A NICE Medical Technologies Guidance.PharmacoEconomics - open · 2021Review
- Melatonin Moderates the Triangle of Chronic Pain, Sleep Architecture and Immunometabolic Traffic.Biomedicines · 2021Review
- Application of Noninvasive Vagal Nerve Stimulation to Stress-Related Psychiatric Disorders.Journal of personalized medicine · 2020Review
- Reducing Episodic Cluster Headaches: Focus on Galcanezumab.Journal of pain research · 2020Review
- Migraine and cluster headache - the common link.The journal of headache and pain · 2018Review
- A new era in headache treatment.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2018Review
- Therapeutic Approaches for the Management of Trigeminal Autonomic Cephalalgias.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2018Review
- Treatment of the Patient with Refractory Headache.Current pain and headache reports · 2018Review
- Spotlight on cervical vagus nerve stimulation for the treatment of primary headache disorders: a review.Journal of pain research · 2018Review
- Electrical stimulation of cranial nerves in cognition and disease.Brain stimulationReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn the PREVention and Acute treatment of chronic cluster headache (PREVA) study, attack frequency reductions from baseline were significantly more pronounced with non-invasive vagus nerve stimulation plus standard of care (nVNS + SoC) than with SoC alone. Given the intensely painful and frequent nature of chronic cluster headache attacks, additional patient-centric outcomes, including the time to and level of therapeutic response, were evaluated in a post hoc analysis of the PREVA study.
findingsAfter a 2-week baseline phase, 97 patients with chronic cluster headache entered a 4-week randomised phase to receive nVNS + SoC (n = 48) or SoC alone (n = 49). All 92 patients who continued into a 4-week extension phase received nVNS + SoC. Compared with SoC alone, nVNS + SoC led to a significantly lower mean weekly attack frequency by week 2 of the randomised phase; the attack frequency remained significantly lower in the nVNS + SoC group through week 3 of the extension phase (P < 0.02). Attack frequencies in the nVNS + SoC group were significantly lower at all study time points than they were at baseline (P < 0.05). Response rates were significantly greater with nVNS + SoC than with SoC alone when response was defined as attack frequency reductions of ≥25%, ≥50%, and ≥75% from baseline (≥25% and ≥50%, P < 0.001; ≥75%, P = 0.009). The 100% response rate was 8% with nVNS + SoC and 0% with SoC alone.
conclusionsProphylactic nVNS led to rapid, significant, and sustained reductions in chronic cluster headache attack frequency within 2 weeks after its addition to SoC and was associated with significantly higher ≥25%, ≥50%, and ≥75% response rates than SoC alone. The rapid decrease in weekly attack frequency justifies a 4-week trial period to identify responders to nVNS, with a high degree of confidence, among patients with chronic cluster headache.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.