Evidence map›Paper›PMID 39888101›Full record

Trial reportNeurogastroenterology and motility2025

Cardiac Vagal Efficiency Is Enhanced by Percutaneous Auricular Neurostimulation in Adolescents With Nausea: Moderation by Antidepressant Drug Exposure.

Jacek Kolacz, Olivia K Roath, Gregory F Lewis, Katja Karrento

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurogastroenterology and motility, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06863207 (Autonomic Reactivity to Restore a Dysregulated Brain-Gut Axis Via Targeted Therapy), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT06863207 narecruitingnot on this map

Autonomic Reactivity to Restore a Dysregulated Brain-Gut Axis Via Targeted Therapy

TypeinterventionalSponsorMedical College of WisconsinRan2025 to 2029Enrolled120ConditionsFunctional Gastrointestinal Disorders (FGIDs), Cyclic Vomiting Syndrome, Functional Dyspepsia, DysautonomiaArmsPercutaneous electrical nerve field stimulation, Hypnotherapy
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. 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

4 authors.

Jacek KolaczDepartment of Psychiatry and Behavioral Health, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Olivia K RoathDepartment of Psychiatry and Behavioral Health, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Gregory F LewisTraumatic Stress Research Consortium, Kinsey Institute, Indiana University, Bloomington, Indiana, USA.
Katja KarrentoDivision of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.

Funding

Defining Adolescent Nausea through Brain-Gut Physiology and Neurostimulation ResponseK23DK116969 · NIDDK · MEDICAL COLLEGE OF WISCONSIN · PI KARRENTO, KATJA KRISTINA · 2018 to 2022
$964k
Chaja FoundationChildren's Wisconsin Research InstituteNIDDK NIH HHS K23 DK116969
6 · The paper itself

Abstract

objectivesPercutaneous electrical nerve field stimulation (PENFS) is an effective treatment for disorders of gut-brain interaction (DGBI), proposed to influence vagal pathways. Cardiac metrics such as respiratory sinus arrythmia (RSA) and vagal efficiency (VE) can noninvasively assess parasympathetic output. Commonly used antidepressant drugs inhibit vagal signaling and may interfere with PENFS. This study examined immediate effects of active compared to sham PENFS on cardiac vagal function in adolescents with chronic nausea with and without concurrent drug therapy. MATERIALS AND

methodsParticipants (n = 84) were randomized to active (3.2 V, 1-10 Hz) or sham PENFS within an 8-week prospective, double-blind clinical trial. Subjects underwent posture challenges to elicit a vagal response before and after PENFS device placement mid-way through the study. RSA, mean heart period (HP), and VE were calculated from electrocardiogram recordings. Exposure to antidepressant drugs was recorded.

resultsThe mean (SD) age was 15.61 (2.07) years (83% female). Fifty percent were treated with antidepressants. PENFS neurostimulation enhanced VE in patients without antidepressant exposure (mean increase after PENFS stimulation =7.56 [95% CI: 0.26, 14.86], d = 0.30, 17% increase) but not in those treated with antidepressants (mean change = -5.30 [95% CI:-14.28, 3.68]). Sham PENFS did not produce significant VE changes regardless of medication use (both p > 0.40). There were no significant effects on RSA or HP.

conclusionsAcute enhancement of cardiac VE is demonstrated with PENFS in patients not exposed to chronic antidepressant drug therapy. Findings indicate that VE is a sensitive metric for rapid assessment of PENFS effects but raise concern for possible interaction or interference by standard of care medications.

trial registrationClinicaltrials.gov #: 1064187-2.

Indexed as

Antidepressive AgentsNauseaTranscutaneous Electric Nerve StimulationVagus NerveAdolescentDouble-Blind MethodFemaleHumansMaleProspective StudiesVagus Nerve StimulationAntidepressive Agentsdisorders of gut–brain interactionfunctional gastrointestinal disordersfunctional nauseaneuromodulationneurostimulationvagal efficiency

Identifiers

PMID39888101
PMCPMC11996051

What Socratic holds

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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 Socratic graph.