Evidence map›Paper›PMID 34276328›Full record

ArticleFrontiers in human neuroscience2021

Randomized Cross Over Study Assessing the Efficacy of Non-invasive Stimulation of the Vagus Nerve in Patients With Axial Spondyloarthritis Resistant to Biotherapies: The ESNV-SPA Study Protocol.

Eric Azabou, Guillaume Bao, Félicie Costantino, Madalina Jacota, Chanez Lazizi, Lionelle Nkam, Martin Rottman, Anne-Laure Roux, Sylvain Chevallier, Lamiae Grimaldi and 1 more

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In one paragraph

Article in Frontiers in human neuroscience, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.1field-weighted citation impact, top 56% of its field
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Eric AzabouClinical Neurophysiology and Neuromodulation Unit, Department of Physiology, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
Guillaume BaoClinical Neurophysiology and Neuromodulation Unit, Department of Physiology, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
Félicie CostantinoLaboratory of Infection and Inflammation (2I)-Inserm UMR 1173, University of Versailles Saint-Quentin en Yvelines (UVSQ), Paris-Saclay University, Paris, France.
Madalina JacotaClinical Research Unit, Ambroise Paré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Boulogne-Billancourt, France, University of Versailles Saint-Quentin en Yvelines, Paris-Saclay University, Paris, France.
Chanez LaziziClinical Research Unit, Ambroise Paré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Boulogne-Billancourt, France, University of Versailles Saint-Quentin en Yvelines, Paris-Saclay University, Paris, France.
Lionelle NkamClinical Research Unit, Ambroise Paré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Boulogne-Billancourt, France, University of Versailles Saint-Quentin en Yvelines, Paris-Saclay University, Paris, France.
Martin RottmanLaboratory of Infection and Inflammation (2I)-Inserm UMR 1173, University of Versailles Saint-Quentin en Yvelines (UVSQ), Paris-Saclay University, Paris, France.
Anne-Laure RouxLaboratory of Infection and Inflammation (2I)-Inserm UMR 1173, University of Versailles Saint-Quentin en Yvelines (UVSQ), Paris-Saclay University, Paris, France.
Sylvain ChevallierVersailles Engineering Systems Laboratory (LISV), University of Versailles Saint Quentin en Yvelines (UVSQ), Vélizy, France.
Lamiae GrimaldiClinical Research Unit, Ambroise Paré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Boulogne-Billancourt, France, University of Versailles Saint-Quentin en Yvelines, Paris-Saclay University, Paris, France.
Maxime BrebanLaboratory of Infection and Inflammation (2I)-Inserm UMR 1173, University of Versailles Saint-Quentin en Yvelines (UVSQ), Paris-Saclay University, Paris, France.
Assistance Publique – Hôpitaux de Paris · FRInfection et inflammationUniversité de Versailles Saint-Quentin-en-Yvelines · FRHôpital Raymond-Poincaré · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Axial spondyloarthritis (SpA), is a major cause of chronic pain and disability that profoundly alters the quality of life of patients. Nearly half of patients with SpA usually develop drug resistance. Non-pharmacological treatments targeting inflammation are an attractive alternative to drug administration. Vagus nerve stimulation (VNS), by promoting a cholinergic anti-inflammatory reflex holds promise for treating inflammatory disease. Inflammatory reflex signaling, which is enhanced by electrically stimulating the vagus nerve, significantly reduces cytokine production and attenuates disease severity in animal models of endotoxemia, sepsis, colitis, and other preclinical models of inflammatory diseases. It has been proposed that vagal efferent fibers release acetylcholine (Ach), which can interact with α7-subunit-containing nicotinic receptors expressed by tissue macrophages and other immune cells to rapidly inhibit the synthesis/release of pro-inflammatory cytokines such as TNFα, IL-1β, IL-6, and IL-18. External vagal nerve stimulation devices are now available that do not require surgery nor implantation to non-invasively stimulate the vagal nerve. This double-blind randomized cross-over clinical trial aims to study the change in SpA disease activity, according to Assessment in Ankylosing Spondylitis 20 (ASAS20) definition, after 12 weeks of non-invasive VNS treatment vs. non-specific dummy stimulation (control group). One hundred and twenty adult patients with drug resistant SpA, meeting the ASAS classification criteria, will be included in the study. Patients will be randomized into two parallel groups according to a cross over design: either active VNS for 12 weeks, then dummy stimulation for 12 weeks, or dummy stimulation for 12 weeks, then active VNS for 12 weeks. The two stimulation periods will be separated by a 4 weeks wash-out period. A transcutaneous auricular vagus nerve stimulator Tens Eco Plus SCHWA MEDICO

Indexed as

axial spondyloarthritismedical deviceneuromodulationprotocoltrialvagus nerve

Identifiers

PMID34276328
PMCPMC8278783
OpenAlexW3174257999

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.