Evidence map›Paper›PMID 32192678›Full record

Trial reportJACC. Clinical electrophysiology2020

TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial.

Stavros Stavrakis, Julie A Stoner, Mary Beth Humphrey, Lynsie Morris, Adrian Filiberti, Justin C Reynolds, Khaled Elkholey, Isma Javed, Nicholas Twidale, Pavel Riha and 5 more

6 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in JACC. Clinical electrophysiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 148 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
148citing papers in PubMed, 7 pooled it
11.5field-weighted citation impact, top 1% 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.

NCT02548754 nacompletednot on this map

TRanscutaneous Electrical vAgus Nerve sTimulation to Suppress Atrial Fibrillation

TypeinterventionalSponsorUniversity of OklahomaRan2016 to 2020Enrolled53ConditionsAtrial Fibrillation, InflammationArmsParasym device
NCT04514757 nacompletednot on this mapstarted 2021, after this paper: background citation

Transcutaneous (Tragus) Vagal Nerve Stimulation (tVNS) for Post-op Atrial Fibrillation (POAF)

TypeinterventionalSponsorUniversity of California, Los AngelesRan2021 to 2024Enrolled77ConditionsAtrial FibrillationArmsactive tVNS, sham tVNS
NCT05230628 naactive not recruitingnot on this mapstarted 2022, after this paper: background citation

The Effectiveness of Transcutaneous Electrical Nerve Stimulation of the Auricular Branch of the Vagus Nerve in Loss Weight and Improving the Quality of Life in Patients With Obesity

TypeinterventionalSponsorNational Medical Research Center for Therapy and Preventive MedicineRan2022 to 2026Enrolled131ConditionsVagus Nerve Stimulation, ObesityArmsActive TENS, Sham TENS
NCT05350150 naactive not recruitingnot on this mapstarted 2022, after this paper: background citation

Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study (VNS-EPS)

TypeinterventionalSponsorNorthwell HealthRan2022 to 2026Enrolled10ConditionsNeuromodulationArmsAuricular Vagal Nerve Stimulation
NCT05944575 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Ventricular Rate Control in Patients With Persistent Atrial Fibrillation

TypeinterventionalSponsorBurrell College of Health SciencesRan2023 to 2025Enrolled30ConditionsAtrial Fibrillation, PersistentArmsactive taVNS, sham-taVNS
NCT07093034 nacompletednot on this mapstarted 2025, after this paper: background citation

Sustained Auricular Nerve Stimulation for PVC Suppression

TypeinterventionalSponsorUniversity of California, San DiegoRan2025 to 2026Enrolled16ConditionsPremature Ventricular Complexes, PVC - Premature Ventricular Contraction, Auricular Vagus Nerve StimulationArmsExtended nocturnal use of auricular vagus nerve stimulator device
3 · Its place in the literature

Who cites it

148 citing papers in PubMed, 7 syntheses or guidelines pooled it, 226 citations in OpenAlex.

  1. Pooled it
  2. Pulmonary vein isolation plus adjunctive therapy for the treatment of atrial fibrillation: a systematic review and meta-analysis.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Acute right-sided transcutaneous vagus nerve stimulation improves cardio-vagal baroreflex gain in patients with chronic heart failure.Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2025
    Trial
  11. Trial
  12. Trial
  13. Noninvasive low-level tragus stimulation attenuates inflammation and oxidative stress in acute heart failure.Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2023
    Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Hypertension: a missing piece in HFpEF?Hypertension research : official journal of the Japanese Society of Hypertension · 2026
    Review
  20. Article

88 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 1 institution in 1 country.

Stavros StavrakisUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA. Electronic address: stavros-stavrakis@ouhsc.edu.
Julie A StonerUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Mary Beth HumphreyUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Lynsie MorrisUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Adrian FilibertiUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Justin C ReynoldsUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Khaled ElkholeyUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Isma JavedUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Nicholas TwidaleUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Pavel RihaUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Subha VarahanUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Benjamin J ScherlagUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Warren M JackmanUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Tarun W DasariUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Sunny S PoUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
University of Oklahoma Health Sciences Center · US

Funding

Tracking and Evaluation CoreU54GM104938 · NIGMS · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI JENNIFER DAVID PECK · 2013 to 2026
$68.2M
Proteomics CoreP20GM103447 · NIGMS · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI David W Dyer · 2012 to 2026
$60.2M
Neuromodulation of Inflammation to Treat Heart Failure with Preserved Ejection FractionR21AG057879 · NIA · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI STAVRAKIS, STAVROS · 2018 to 2019
$407k
NIA NIH HHS R21 AG057879NIGMS NIH HHS P20 GM103447NIGMS NIH HHS U54 GM104938
6 · The paper itself

Abstract

objectivesThis study was a sham-controlled, double-blind, randomized clinical trial to examine the effect of chronic low level tragus stimulation (LLTS) in patients with paroxysmal AF.

backgroundLow-level transcutaneous electrical stimulation of the auricular branch of the vagus nerve at the tragus (LLTS) acutely suppresses atrial fibrillation (AF) in humans, but the chronic effect remains unknown.

methodsLLTS (20 Hz, 1 mA below the discomfort threshold) was delivered using an ear clip attached to the tragus (active arm) (n = 26) or the ear lobe (sham control arm) (n = 27) for 1 h daily over 6 months. AF burden over 2-week periods was assessed by noninvasive continuous electrocardiogram monitoring at baseline, 3 months, and 6 months. Five-minute electrocardiography and serum were obtained at each visit to measure heart rate variability and inflammatory cytokines, respectively.

resultsBaseline characteristics were balanced between the 2 groups. Adherence to the stimulation protocol (≤4 sessions lost per month) was 75% in the active arm and 83% in the control arm (p > 0.05). At 6 months, the median AF burden was 85% lower in the active arm compared with the control arm (ratio of medians: 0.15; 95% confidence interval: 0.03 to 0.65; p = 0.011). Tumor necrosis factor-alpha was significantly decreased by 23% in the active group relative to the control group (ratio of medians: 0.77; 95% confidence interval: 0.63 to 0.94; p = 0.0093). Frequency domain indices of heart rate variability were significantly altered with active versus control stimulation (p < 0.01). No device-related side effects were observed.

conclusionsChronic, intermittent LLTS resulted in lower AF burden than did sham control stimulation, supporting its use to treat paroxysmal AF in selected patients. (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation [TREAT-AF]; NCT02548754).

Indexed as

AgedAtrial FibrillationDouble-Blind MethodEar, ExternalElectrocardiographyFemaleHumansMaleMiddle AgedTranscutaneous Electric Nerve StimulationVagus Nerveatrial fibrillationneuromodulationrandomized clinical trial

Identifiers

PMID32192678
PMCPMC7100921
OpenAlexW3004048302

What Socratic holds

Textmetadata
LicenceTDM
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 Socratic graph.