Trial reportNeurology2018
Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study.
4 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph
Trial report in Neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 115 papers, 10 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
115citing papers in PubMed, 10 pooled it
–field-weighted citation impact
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Prospective, Multi-centre, Randomized, Double-blind, Sham-controlled Study of gammaCore® Non-invasive Vagus Nerve Stimulator (nVNS), for the Acute Treatment of Migraine
A Randomized, Single-Center, Double-Blind, Parallel, Sham-Controlled Study of Gammacore Sapphire (Non-Invasive Vagus Nerve Stimulator) for the Acute and Preventive Treatment of Post-Traumatic Headache (GAP-PTH)
The Effect Of Transcutaneous Auricular Vagus Nerve Stimulation On Sports Performance And Physiological Parameters In Healthy Young Individuals: Randomized, Double-Blind Study
Effects of Vagal Nerve Stimulation on Pain Frequency and Intensity in Chronic Migraine
Who cites it
115 citing papers in PubMed, 10 syntheses or guidelines pooled it.
- Efficacy, IHS Guideline Adherence, and Methodological Quality of Noninvasive Neuromodulation Clinical Trials in Migraine and Cluster Headache: A Systematic Review.European journal of neurology · 2026Pooled it
- Noninvasive Vagus Nerve Stimulation for Cluster Headache and Migraine: A Health Technology Assessment.Ontario health technology assessment series · 2025Pooled it
- Outcomes of transcutaneous nerve stimulation for migraine headaches: a systematic review and meta-analysis.Journal of neurology · 2022Pooled it
- The potential for autonomic neuromodulation to reduce perioperative complications and pain: a systematic review and meta-analysis.British journal of anaesthesia · 2022Pooled it
- Non-invasive neuromodulation in the acute treatment of migraine: a systematic review and meta-analysis of randomized controlled trials.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022Pooled it
- Pooled it
- Non-invasive Autonomic Neuromodulation Is Opening New Landscapes for Cardiovascular Diseases.Frontiers in physiology · 2020Pooled it
- Vagus nerve stimulation for primary headache disorders: An anatomical review to explain a clinical phenomenon.Cephalalgia : an international journal of headache · 2019Pooled it
- Non-invasive neuromodulation for migraine and cluster headache: a systematic review of clinical trials.Journal of neurology, neurosurgery, and psychiatry · 2019Pooled it
- The effectiveness of non-invasive vagus nerve stimulation in migraine management: a meta-analysis of randomized controlled trials.Frontiers in neurologyPooled it
- Feasibility and Safety of a Single-Session of Transcutaneous Cervical Magnetic Stimulation, taVNS, and iTBS on Heart Rate Variability, Safety, and Pain Modulation.The European journal of neuroscience · 2025Trial
- Efficacy of transauricular vagus nerve stimulation for the treatment of chemotherapy-induced painful peripheral neuropathy: a randomized controlled exploratory study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024Trial
- Heart rate variability and cold-induced vascular dilation after stimulation of two different areas of the ear: a prospective, single-blinded, randomized crossover study.BMC complementary medicine and therapies · 2024Trial
- A Randomized, Sham-Controlled Trial of Cranial Electrical Stimulation for Fibromyalgia Pain and Physical Function, Using Brain Imaging Biomarkers.Journal of visualized experiments : JoVE · 2024Trial
- A Prospective, Multicenter Study to Assess the Safety and Efficacy of Translingual Neurostimulation Plus Physical Therapy for the Treatment of a Chronic Balance Deficit Due to Mild-to-Moderate Traumatic Brain Injury.Neuromodulation : journal of the International Neuromodulation Society · 2021Trial
- Trial
- Effect and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Recovery of Upper Limb Motor Function in Subacute Ischemic Stroke Patients: A Randomized Pilot Study.Neural plasticity · 2020Trial
- Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial.Cephalalgia : an international journal of headache · 2019Trial
- Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial.Headache · 2019Trial
- Remote electrical neuromodulation (REN) in the acute treatment of migraine: a comparison with usual care and acute migraine medications.The journal of headache and pain · 2019Trial
55 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Cristina TassorelliFrom the Headache Science Centre (C.T.), IRCCS C. Mondino Foundation, Pavia; University of Pavia (C.T.); Headache Center (L.G.), Carlo Besta Neurological Institute and Foundation, Milan; Neurophysiology and Pain Unit (M.d.T.), University of Bari Aldo Moro; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) (G.P.), Istituto delle Scienze Neurologiche di Bologna; Department of Clinical and Molecular Medicine (P.M.), Sapienza University, Rome; Department of Neuroscience (I.R.), University of Turin, Italy; MedLogix Communications, LLC (S.D.), Itasca IL; Headache Centre (P.G.), University Hospital of Careggi, Florence; IRCCS Neuromed (A.A.), Pozzilli (IS); Neurologic Clinic (P.S.), Santa Maria della Misericordia Hospital, Perugia, Italy; electroCore, LLC (E.L.), Basking Ridge, NJ; and Headache and Pain Unit (P.B.), IRCCS San Raffaele Pisana, Rome, Italy. cristina.tassorelli@mondino.it.
Licia GrazziFrom the Headache Science Centre (C.T.), IRCCS C. Mondino Foundation, Pavia; University of Pavia (C.T.); Headache Center (L.G.), Carlo Besta Neurological Institute and Foundation, Milan; Neurophysiology and Pain Unit (M.d.T.), University of Bari Aldo Moro; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) (G.P.), Istituto delle Scienze Neurologiche di Bologna; Department of Clinical and Molecular Medicine (P.M.), Sapienza University, Rome; Department of Neuroscience (I.R.), University of Turin, Italy; MedLogix Communications, LLC (S.D.), Itasca IL; Headache Centre (P.G.), University Hospital of Careggi, Florence; IRCCS Neuromed (A.A.), Pozzilli (IS); Neurologic Clinic (P.S.), Santa Maria della Misericordia Hospital, Perugia, Italy; electroCore, LLC (E.L.), Basking Ridge, NJ; and Headache and Pain Unit (P.B.), IRCCS San Raffaele Pisana, Rome, Italy.
Marina de TommasoFrom the Headache Science Centre (C.T.), IRCCS C. Mondino Foundation, Pavia; University of Pavia (C.T.); Headache Center (L.G.), Carlo Besta Neurological Institute and Foundation, Milan; Neurophysiology and Pain Unit (M.d.T.), University of Bari Aldo Moro; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) (G.P.), Istituto delle Scienze Neurologiche di Bologna; Department of Clinical and Molecular Medicine (P.M.), Sapienza University, Rome; Department of Neuroscience (I.R.), University of Turin, Italy; MedLogix Communications, LLC (S.D.), Itasca IL; Headache Centre (P.G.), University Hospital of Careggi, Florence; IRCCS Neuromed (A.A.), Pozzilli (IS); Neurologic Clinic (P.S.), Santa Maria della Misericordia Hospital, Perugia, Italy; electroCore, LLC (E.L.), Basking Ridge, NJ; and Headache and Pain Unit (P.B.), IRCCS San Raffaele Pisana, Rome, Italy.
Giulia PierangeliFrom the Headache Science Centre (C.T.), IRCCS C. Mondino Foundation, Pavia; University of Pavia (C.T.); Headache Center (L.G.), Carlo Besta Neurological Institute and Foundation, Milan; Neurophysiology and Pain Unit (M.d.T.), University of Bari Aldo Moro; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) (G.P.), Istituto delle Scienze Neurologiche di Bologna; Department of Clinical and Molecular Medicine (P.M.), Sapienza University, Rome; Department of Neuroscience (I.R.), University of Turin, Italy; MedLogix Communications, LLC (S.D.), Itasca IL; Headache Centre (P.G.), University Hospital of Careggi, Florence; IRCCS Neuromed (A.A.), Pozzilli (IS); Neurologic Clinic (P.S.), Santa Maria della Misericordia Hospital, Perugia, Italy; electroCore, LLC (E.L.), Basking Ridge, NJ; and Headache and Pain Unit (P.B.), IRCCS San Raffaele Pisana, Rome, Italy.
Paolo MartellettiFrom the Headache Science Centre (C.T.), IRCCS C. Mondino Foundation, Pavia; University of Pavia (C.T.); Headache Center (L.G.), Carlo Besta Neurological Institute and Foundation, Milan; Neurophysiology and Pain Unit (M.d.T.), University of Bari Aldo Moro; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) (G.P.), Istituto delle Scienze Neurologiche di Bologna; Department of Clinical and Molecular Medicine (P.M.), Sapienza University, Rome; Department of Neuroscience (I.R.), University of Turin, Italy; MedLogix Communications, LLC (S.D.), Itasca IL; Headache Centre (P.G.), University Hospital of Careggi, Florence; IRCCS Neuromed (A.A.), Pozzilli (IS); Neurologic Clinic (P.S.), Santa Maria della Misericordia Hospital, Perugia, Italy; electroCore, LLC (E.L.), Basking Ridge, NJ; and Headache and Pain Unit (P.B.), IRCCS San Raffaele Pisana, Rome, Italy.
Innocenzo RaineroFrom the Headache Science Centre (C.T.), IRCCS C. Mondino Foundation, Pavia; University of Pavia (C.T.); Headache Center (L.G.), Carlo Besta Neurological Institute and Foundation, Milan; Neurophysiology and Pain Unit (M.d.T.), University of Bari Aldo Moro; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) (G.P.), Istituto delle Scienze Neurologiche di Bologna; Department of Clinical and Molecular Medicine (P.M.), Sapienza University, Rome; Department of Neuroscience (I.R.), University of Turin, Italy; MedLogix Communications, LLC (S.D.), Itasca IL; Headache Centre (P.G.), University Hospital of Careggi, Florence; IRCCS Neuromed (A.A.), Pozzilli (IS); Neurologic Clinic (P.S.), Santa Maria della Misericordia Hospital, Perugia, Italy; electroCore, LLC (E.L.), Basking Ridge, NJ; and Headache and Pain Unit (P.B.), IRCCS San Raffaele Pisana, Rome, Italy.
Stefanie DorlasFrom the Headache Science Centre (C.T.), IRCCS C. Mondino Foundation, Pavia; University of Pavia (C.T.); Headache Center (L.G.), Carlo Besta Neurological Institute and Foundation, Milan; Neurophysiology and Pain Unit (M.d.T.), University of Bari Aldo Moro; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) (G.P.), Istituto delle Scienze Neurologiche di Bologna; Department of Clinical and Molecular Medicine (P.M.), Sapienza University, Rome; Department of Neuroscience (I.R.), University of Turin, Italy; MedLogix Communications, LLC (S.D.), Itasca IL; Headache Centre (P.G.), University Hospital of Careggi, Florence; IRCCS Neuromed (A.A.), Pozzilli (IS); Neurologic Clinic (P.S.), Santa Maria della Misericordia Hospital, Perugia, Italy; electroCore, LLC (E.L.), Basking Ridge, NJ; and Headache and Pain Unit (P.B.), IRCCS San Raffaele Pisana, Rome, Italy.
Pierangelo GeppettiFrom the Headache Science Centre (C.T.), IRCCS C. Mondino Foundation, Pavia; University of Pavia (C.T.); Headache Center (L.G.), Carlo Besta Neurological Institute and Foundation, Milan; Neurophysiology and Pain Unit (M.d.T.), University of Bari Aldo Moro; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) (G.P.), Istituto delle Scienze Neurologiche di Bologna; Department of Clinical and Molecular Medicine (P.M.), Sapienza University, Rome; Department of Neuroscience (I.R.), University of Turin, Italy; MedLogix Communications, LLC (S.D.), Itasca IL; Headache Centre (P.G.), University Hospital of Careggi, Florence; IRCCS Neuromed (A.A.), Pozzilli (IS); Neurologic Clinic (P.S.), Santa Maria della Misericordia Hospital, Perugia, Italy; electroCore, LLC (E.L.), Basking Ridge, NJ; and Headache and Pain Unit (P.B.), IRCCS San Raffaele Pisana, Rome, Italy.
Anna AmbrosiniFrom the Headache Science Centre (C.T.), IRCCS C. Mondino Foundation, Pavia; University of Pavia (C.T.); Headache Center (L.G.), Carlo Besta Neurological Institute and Foundation, Milan; Neurophysiology and Pain Unit (M.d.T.), University of Bari Aldo Moro; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) (G.P.), Istituto delle Scienze Neurologiche di Bologna; Department of Clinical and Molecular Medicine (P.M.), Sapienza University, Rome; Department of Neuroscience (I.R.), University of Turin, Italy; MedLogix Communications, LLC (S.D.), Itasca IL; Headache Centre (P.G.), University Hospital of Careggi, Florence; IRCCS Neuromed (A.A.), Pozzilli (IS); Neurologic Clinic (P.S.), Santa Maria della Misericordia Hospital, Perugia, Italy; electroCore, LLC (E.L.), Basking Ridge, NJ; and Headache and Pain Unit (P.B.), IRCCS San Raffaele Pisana, Rome, Italy.
Paola SarchielliFrom the Headache Science Centre (C.T.), IRCCS C. Mondino Foundation, Pavia; University of Pavia (C.T.); Headache Center (L.G.), Carlo Besta Neurological Institute and Foundation, Milan; Neurophysiology and Pain Unit (M.d.T.), University of Bari Aldo Moro; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) (G.P.), Istituto delle Scienze Neurologiche di Bologna; Department of Clinical and Molecular Medicine (P.M.), Sapienza University, Rome; Department of Neuroscience (I.R.), University of Turin, Italy; MedLogix Communications, LLC (S.D.), Itasca IL; Headache Centre (P.G.), University Hospital of Careggi, Florence; IRCCS Neuromed (A.A.), Pozzilli (IS); Neurologic Clinic (P.S.), Santa Maria della Misericordia Hospital, Perugia, Italy; electroCore, LLC (E.L.), Basking Ridge, NJ; and Headache and Pain Unit (P.B.), IRCCS San Raffaele Pisana, Rome, Italy.
Eric LieblerFrom the Headache Science Centre (C.T.), IRCCS C. Mondino Foundation, Pavia; University of Pavia (C.T.); Headache Center (L.G.), Carlo Besta Neurological Institute and Foundation, Milan; Neurophysiology and Pain Unit (M.d.T.), University of Bari Aldo Moro; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) (G.P.), Istituto delle Scienze Neurologiche di Bologna; Department of Clinical and Molecular Medicine (P.M.), Sapienza University, Rome; Department of Neuroscience (I.R.), University of Turin, Italy; MedLogix Communications, LLC (S.D.), Itasca IL; Headache Centre (P.G.), University Hospital of Careggi, Florence; IRCCS Neuromed (A.A.), Pozzilli (IS); Neurologic Clinic (P.S.), Santa Maria della Misericordia Hospital, Perugia, Italy; electroCore, LLC (E.L.), Basking Ridge, NJ; and Headache and Pain Unit (P.B.), IRCCS San Raffaele Pisana, Rome, Italy.
Piero BarbantiFrom the Headache Science Centre (C.T.), IRCCS C. Mondino Foundation, Pavia; University of Pavia (C.T.); Headache Center (L.G.), Carlo Besta Neurological Institute and Foundation, Milan; Neurophysiology and Pain Unit (M.d.T.), University of Bari Aldo Moro; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) (G.P.), Istituto delle Scienze Neurologiche di Bologna; Department of Clinical and Molecular Medicine (P.M.), Sapienza University, Rome; Department of Neuroscience (I.R.), University of Turin, Italy; MedLogix Communications, LLC (S.D.), Itasca IL; Headache Centre (P.G.), University Hospital of Careggi, Florence; IRCCS Neuromed (A.A.), Pozzilli (IS); Neurologic Clinic (P.S.), Santa Maria della Misericordia Hospital, Perugia, Italy; electroCore, LLC (E.L.), Basking Ridge, NJ; and Headache and Pain Unit (P.B.), IRCCS San Raffaele Pisana, Rome, Italy.
PRESTO Study Group
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the efficacy, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS; gammaCore; electroCore, LLC, Basking Ridge, NJ) for the acute treatment of migraine in a multicenter, double-blind, randomized, sham-controlled trial.
methodsA total of 248 participants with episodic migraine with/without aura were randomized to receive nVNS or sham within 20 minutes from pain onset. Participants were to repeat treatment if pain had not improved in 15 minutes.
resultsnVNS (n = 120) was superior to sham (n = 123) for pain freedom at 30 minutes (12.7% vs 4.2%;
conclusionThis randomized sham-controlled trial supports the abortive efficacy of nVNS as early as 30 minutes and up to 60 minutes after an attack. Findings also suggest effective pain relief, tolerability, and practicality of nVNS for the acute treatment of episodic migraine. CLINICALTRIALSGOV IDENTIFIER: NCT02686034. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free 2 hours poststimulation (absolute difference 13.2%).
Indexed as
AdultDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersPain MeasurementProspective StudiesTreatment OutcomeVagus Nerve Stimulation
Identifiers
What OpenQuestion holds
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LicenceCC BY-NC-ND
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Registered trials
NCT02686034ClinicalTrials.gov
NCT04071743ClinicalTrials.gov
NCT04768738ClinicalTrials.gov
NCT06191016ClinicalTrials.gov
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.