Evidence map›Paper›PMID 42552546›Full record

ArticleBMC psychology2026

tVNS and obesity-related inflammation: a prospective sham-controlled randomized crossover study protocol.

Luisa Kaluza, Anne Kühnel, Ernesto Picòn-Galindo, Mona Hergenröther, Hesham Alkhateeb, Simon Michalski, Dalila Juliana Silva Ribeiro, Susanne V Schmidt, Dagmar Wachten, Nils B Kroemer

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06954844 (tVNS to Provide Mechanistic Insights Into the Relationship Between Systemic Inflammation and Altered Motivation and Mood in Healthy Individuals Who Are Overweight or Obese), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT06954844 naenrolling by invitationnot on this map

tVNS to Provide Mechanistic Insights Into the Relationship Between Systemic Inflammation and Altered Motivation and Mood in Healthy Individuals Who Are Overweight or Obese

TypeinterventionalSponsorUniversity of BonnRan2025 to 2027Enrolled60ConditionsOverweight/Obesity (BMI: 27 and 35 kg/m2)ArmsTranscutaneous non-invasive vagus nerve stimulation (tVNS), Low intensity stimulation
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Luisa KaluzaDepartment of Psychiatry and Psychotherapy, Section of Medical Psychology, University Hospital Bonn, University of Bonn, Venusberg Campus 1, Bonn, 53127, Germany.ORCID http://orcid.org/0009-0006-1450-0163
Anne KühnelDepartment of Psychiatry and Psychotherapy, Section of Medical Psychology, University Hospital Bonn, University of Bonn, Venusberg Campus 1, Bonn, 53127, Germany.ORCID http://orcid.org/0000-0003-3066-3801
Ernesto Picòn-GalindoInstitute of Innate Immunity, Biophysical Imaging, University Hospital Bonn, University of Bonn, Bonn, Germany.ORCID http://orcid.org/0000-0001-7174-6561
Mona HergenrötherDepartment of Psychiatry and Psychotherapy, Section of Medical Psychology, University Hospital Bonn, University of Bonn, Venusberg Campus 1, Bonn, 53127, Germany.
Hesham AlkhateebDepartment of Psychiatry and Psychotherapy, Section of Medical Psychology, University Hospital Bonn, University of Bonn, Venusberg Campus 1, Bonn, 53127, Germany.
Simon MichalskiDepartment of Psychiatry and Psychotherapy, Section of Medical Psychology, University Hospital Bonn, University of Bonn, Venusberg Campus 1, Bonn, 53127, Germany.
Dalila Juliana Silva RibeiroInstitute of Innate Immunity, Biophysical Imaging, University Hospital Bonn, University of Bonn, Bonn, Germany.
Susanne V SchmidtInstitute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Bonn, 53127, Germany.
Dagmar WachtenInstitute of Innate Immunity, Biophysical Imaging, University Hospital Bonn, University of Bonn, Bonn, Germany.ORCID http://orcid.org/0000-0003-4800-6332
Nils B KroemerDepartment of Psychiatry and Psychotherapy, Section of Medical Psychology, University Hospital Bonn, University of Bonn, Venusberg Campus 1, Bonn, 53127, Germany. nkroemer@uni-bonn.de.ORCID http://orcid.org/0000-0002-9552-3781

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOverweight and obesity are characterized by detrimental effects on energy metabolism and an increase in adipose tissue, leading to chronic low-grade inflammation. This metaflammation may contribute to mental symptoms, such as reduced mood and motivation. Inflammatory processes are modulated by the cholinergic anti-inflammatory pathway (CAIP) that can be targeted with vagus nerve stimulation (VNS). However, the effects of non-invasive transcutaneous VNS (tVNS) on inflammation have predominantly been investigated in small feasibility studies in humans. Whereas acute anti-inflammatory effects of tVNS have been reported, no study has investigated the effect of daily home-based application on obesity-related metaflammation to date.

methodsTo assess tVNS-induced effects on inflammation, motivation, and mood, we are conducting a single-blind, randomized crossover study in participants with an elevated BMI (target N = 60, 27-35 kg/m², 18-40 y). Participants will self-administer high- (active) and low-intensity (sham) stimulation daily (≥ 30 min) for ~ 14 days each (≥ 7 d washout). We will assess peripheral (cytokine levels, circulating immune cells) and central (diffusion weighted imaging) inflammation, motivation (using an effort allocation task during functional MRI), and mood at baseline and after each stimulation phase. During each stimulation phase, participants will complete daily ecological momentary assessments of mood and food choices. We will use mixed-effects models to evaluate differences in slopes of high- vs. low-intensity tVNS. DISCUSSION: This study uses a 14-day home-based tVNS protocol (≥ 30 min daily) accompanied by daily ecologocial momentary assessments to investigate mid-term effects on chronic low-grade inflammation, mood, and motivation. The multimodal study design including a comprehensive panel of peripheral and central inflammatory markers enables the integration of inflammatory and behavioral outcomes and will provide important evidence regarding the efficacy of tVNS in chronic inflammation, based on a study with sufficient statistical power. In addition, the study could provide pathophysiological insights into the link between obesity and symptoms of depression via inflammatory processes. Ultimately, the study will facilitate future research on vagus nerve stimulation to complement the current set of therapies in overweight and obesity.

trial registrationThe study has been preregistered at ClinicalTrials.gov ( https://clinicaltrials.gov/study/NCT06954844 ) on March 21, 2025, Version 1.

Indexed as

InflammationObesityVagus Nerve StimulationAdolescentAdultAffectCross-Over StudiesCytokinesFemaleHumansMaleMotivationProspective StudiesRandomized Controlled Trials as TopicSingle-Blind MethodYoung AdultCytokinesEffortMetaflammationMotivationOverweightVagus nerve stimulation

Identifiers

PMID42552546
PMCPMC13435442

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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 OpenQuestion graph.