Evidence map›Paper›PMID 26049730›Full record

Trial reportArthritis research & therapy2015

Transvenous vagus nerve stimulation does not modulate the innate immune response during experimental human endotoxemia: a randomized controlled study.

Matthijs Kox, Lucas T van Eijk, Tim Verhaak, Tim Frenzel, Harmke D Kiers, Jelle Gerretsen, Johannes G van der Hoeven, Lilian Kornet, Avram Scheiner, Peter Pickkers

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01944228 (Effects of Transvenous Vagus Nerve Stimulation on Immune Response), which is not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 13% 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.

NCT01944228 phase1completednot on this map

Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a Pilot Study

TypeinterventionalSponsorMedtronic Cardiac Rhythm and Heart FailureRan2013 to 2013Enrolled22ConditionsInflammationArmsVagal Nerve Stimulation, Sham Stimulation
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Septic acute kidney injury: a review of basic research.Clinical and experimental nephrology · 2020
    Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Neuroimmune interactions and kidney disease.Kidney research and clinical practice · 2019
    Review
  17. Review
  18. Article
  19. Review
  20. Effort but not Reward Sensitivity is Altered by Acute Sickness Induced by Experimental Endotoxemia in Humans.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2018
    Article
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

10 authors at 4 institutions in 2 countries.

Matthijs KoxDepartment of Intensive Care Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), Geert Grooteplein 10, 6500, HB, Nijmegen, The Netherlands. matthijs.kox@radboudumc.nl.
Lucas T van EijkDepartment of Intensive Care Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), Geert Grooteplein 10, 6500, HB, Nijmegen, The Netherlands. lucas.vaneijk@radboudumc.nl.
Tim VerhaakDepartment of Intensive Care Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), Geert Grooteplein 10, 6500, HB, Nijmegen, The Netherlands. tim_verhaak@hotmail.com.
Tim FrenzelDepartment of Intensive Care Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), Geert Grooteplein 10, 6500, HB, Nijmegen, The Netherlands. tim.frenzel@radboudumc.nl.
Harmke D KiersDepartment of Intensive Care Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), Geert Grooteplein 10, 6500, HB, Nijmegen, The Netherlands. dorien.kiers@radboudumc.nl.
Jelle GerretsenDepartment of Intensive Care Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), Geert Grooteplein 10, 6500, HB, Nijmegen, The Netherlands. jelle.gerretsen@radboudumc.nl.
Johannes G van der HoevenDepartment of Intensive Care Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), Geert Grooteplein 10, 6500, HB, Nijmegen, The Netherlands. hans.vanderhoeven@radboudumc.nl.
Lilian KornetMedtronic Inc., Endepolsdomein 5, 6229, GW, Maastricht, The Netherlands. lilian.kornet@medtronic.com.
Avram ScheinerMedtronic Inc., 8200 Coral Sea St NE, Mounds View, MN, 55112, USA. avram.scheiner@medtronic.com.
Peter PickkersDepartment of Intensive Care Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), Geert Grooteplein 10, 6500, HB, Nijmegen, The Netherlands. peter.pickkers@radboudumc.nl.
Radboud University Medical Center · NLRadboud University Nijmegen · NLMedtronic (Netherlands) · NLMedtronic (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionVagus nerve stimulation (VNS) exerts beneficial anti-inflammatory effects in various animal models of inflammation, including collagen-induced arthritis, and is implicated in representing a novel therapy for rheumatoid arthritis. However, evidence of anti-inflammatory effects of VNS in humans is very scarce. Transvenous VNS (tVNS) is a newly developed and less invasive method to stimulate the vagus nerve. In the present study, we determined whether tVNS is a feasible and safe procedure and investigated its putative anti-inflammatory effects during experimental human endotoxemia.

methodsWe performed a randomized double-blind sham-controlled study in healthy male volunteers. A stimulation catheter was inserted in the left internal jugular vein at spinal level C5-C7, adjacent to the vagus nerve. In the tVNS group (n = 10), stimulation was continuously performed for 30 minutes (0-10 V, 1 ms, 20 Hz), starting 10 minutes before intravenous administration of 2 ng kg(-1) Escherichia coli lipopolysaccharide (LPS). Sham-instrumented subjects (n = 10) received no electrical stimulation.

resultsNo serious adverse events occurred throughout the study. In the tVNS group, stimulation of the vagus nerve was achieved as indicated by laryngeal vibration. Endotoxemia resulted in fever, flu-like symptoms, and hemodynamic changes that were unaffected by tVNS. Furthermore, plasma levels of inflammatory cytokines increased sharply during endotoxemia, but responses were similar between groups. Finally, cytokine production by leukocytes stimulated with LPS ex vivo, as well as neutrophil phagocytosis capacity, were not influenced by tVNS.

conclusionstVNS is feasible and safe, but does not modulate the innate immune response in humans in vivo during experimental human endotoxemia.

trial registrationClinicaltrials.gov NCT01944228. Registered 12 September 2013.

Indexed as

AdultDouble-Blind MethodEndotoxemiaHumansImmunity, InnateInflammationLipopolysaccharidesMaleVagus Nerve StimulationYoung AdultLipopolysaccharides

Identifiers

PMID26049730
PMCPMC4480894
OpenAlexW1814430977

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.